Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT03728257
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2018-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ajdst42@pitt.edu', 'phone': '4126245314', 'title': 'Annette DeVito Dabbs', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 6 months', 'description': 'Per our data safety protocol of the University of Pittsburgh Institutional Review Board (IRB), the definitions of adverse events and or serious adverse events were limited to unanticipated events. Since mortality is an expected event in this population, the causes were reviewed according to our protocol and deemed anticipated and unrelated to participation in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Function- Walking: Change in Average Steps Per Day at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '460', 'spread': '3410', 'groupId': 'OG000'}, {'value': '352', 'spread': '2470', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8793', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in average steps per day between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score).', 'unitOfMeasure': 'average steps per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 3 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function- Walking: Change in Average Steps Per Day at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '445', 'spread': '2310', 'groupId': 'OG000'}, {'value': '405', 'spread': '3570', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9597', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in average steps per day between baseline and 6 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).', 'unitOfMeasure': 'average steps per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 6 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function- Balance: Change in Berg Balance at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in Berg balance between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months.', 'description': 'Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56.\n\nHigher scores indicate a better outcome. Change = (3 month score minus baseline score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 3 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function- Balance: Change From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in Berg balance between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56.\n\nHigher scores indicate a better outcome. Change = (6 month score minus baseline score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 6 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function-Lower Body Strength: Change From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.964', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '0.314', 'spread': '2.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2262', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance is p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months.', 'description': 'Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score).', 'unitOfMeasure': 'repetitiions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 3 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function-Lower Body Strength: Change From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '3.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months.', 'description': 'Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score).', 'unitOfMeasure': 'repetitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 6 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.64', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '-6.45', 'spread': '11.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in SGRQ between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months.', 'description': 'Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of SGRQ between baseline and 3 months.'}, {'type': 'PRIMARY', 'title': 'Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.33', 'spread': '11.26', 'groupId': 'OG000'}, {'value': '-6.83', 'spread': '8.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in SGRQ between baseline and 6 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of respiratory-related quality of life between baseline and 6 months.'}, {'type': 'PRIMARY', 'title': 'Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.18', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7073', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in MVPA between baseline and 3 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months.', 'description': 'The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score).', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 3 months.'}, {'type': 'PRIMARY', 'title': 'Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '9.99', 'groupId': 'OG000'}, {'value': '6.53', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.313', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in MVPA between baseline and 6 months was compared between the two groups.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months.', 'description': 'The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (6 month score minus baseline score).', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 6 months.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Control-Change From Baseline to 3months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold for statistical significance p \\< 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 3 months', 'description': 'Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 3 months.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Control-Change From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'a priori threshold of statistical significance p \\< 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 6 months.', 'description': 'Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'FG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.\n\nLTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1.\n\nIntensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement'}, {'id': 'BG001', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.\n\nEnhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.89', 'spread': '14.01', 'groupId': 'BG000'}, {'value': '57.93', 'spread': '11.79', 'groupId': 'BG001'}, {'value': '56.41', 'spread': '12.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex as documented in the electronic health record.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average steps per day', 'classes': [{'categories': [{'measurements': [{'value': '3169.62', 'spread': '2841.43', 'groupId': 'BG000'}, {'value': '3507.14', 'spread': '2535.84', 'groupId': 'BG001'}, {'value': '3338.16', 'spread': '2682.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Average steps per day calculated by FitBit step tracker (FitBit) worn for 14 day periods at baseline. Minimum = 0, no upper limit. Higher scores mean a better outcome.', 'unitOfMeasure': 'Average steps per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Berg Balance', 'classes': [{'categories': [{'measurements': [{'value': '53.69', 'spread': '2.76', 'groupId': 'BG000'}, {'value': '52.71', 'spread': '4.30', 'groupId': 'BG001'}, {'value': '53.21', 'spread': '3.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Balance was measured using the Berg Balance Score.This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lower body strength', 'classes': [{'categories': [{'measurements': [{'value': '9.64', 'spread': '2.89', 'groupId': 'BG000'}, {'value': '9.78', 'spread': '3.57', 'groupId': 'BG001'}, {'value': '9.70', 'spread': '3.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Lower body strength was measured with the 30-Second Chair-Stand Test. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome', 'unitOfMeasure': 'Repetitions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory-related quality of life St George Respiratory Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '31.65', 'spread': '18.86', 'groupId': 'BG000'}, {'value': '31.16', 'spread': '19.89', 'groupId': 'BG001'}, {'value': '31.40', 'spread': '19.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Respiratory-related quality of life was measured with the St. George Respiratory Questionnaire (SGRQ). The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minutes per day in Moderate and Vigorous Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '13.43', 'groupId': 'BG000'}, {'value': '9.26', 'spread': '9.35', 'groupId': 'BG001'}, {'value': '10.12', 'spread': '11.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph Activity Tracker, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes', 'unitOfMeasure': 'Minutes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-21', 'size': 641381, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-18T11:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two groups. The research study that will compare two methods of self-managing exercise after receiving a lung transplant. These methods are a home-based exercise program plus self-monitoring or self-monitoring alone. The investigator would also like to collect information about the patients health and ability to exercise, and the amount of physical activity the participants do per day. The length of the study will be 6 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2018-10-21', 'resultsFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-18', 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Function- Walking: Change in Average Steps Per Day at Month 3', 'timeFrame': 'Baseline and 3 months', 'description': 'Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score).'}, {'measure': 'Physical Function- Walking: Change in Average Steps Per Day at Month 6', 'timeFrame': 'Baseline and 6 months', 'description': 'Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).'}, {'measure': 'Physical Function- Balance: Change in Berg Balance at Month 3', 'timeFrame': 'Baseline and 3 months.', 'description': 'Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56.\n\nHigher scores indicate a better outcome. Change = (3 month score minus baseline score).'}, {'measure': 'Physical Function- Balance: Change From Baseline to 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56.\n\nHigher scores indicate a better outcome. Change = (6 month score minus baseline score).'}, {'measure': 'Physical Function-Lower Body Strength: Change From Baseline to 3 Months', 'timeFrame': 'Baseline and 3 months.', 'description': 'Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score).'}, {'measure': 'Physical Function-Lower Body Strength: Change From Baseline to 6 Months', 'timeFrame': 'Baseline and 6 months.', 'description': 'Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score).'}, {'measure': 'Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.', 'timeFrame': 'Baseline and 3 months.', 'description': 'Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score).'}, {'measure': 'Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.', 'timeFrame': 'Baseline and 6 months', 'description': 'Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score).'}, {'measure': 'Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.', 'timeFrame': 'Baseline and 3 months.', 'description': 'The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score).'}, {'measure': 'Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.', 'timeFrame': 'Baseline and 6 months.', 'description': 'The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (6 month score minus baseline score).'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Control-Change From Baseline to 3months', 'timeFrame': 'Baseline and 3 months', 'description': 'Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome.'}, {'measure': 'Blood Pressure Control-Change From Baseline to 6 Months', 'timeFrame': 'Baseline and 6 months.', 'description': 'Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Lung Transplantation']}, 'referencesModule': {'references': [{'pmid': '36644217', 'type': 'BACKGROUND', 'citation': 'Hergenroeder AL, Willey B, Vendetti M, Dabbs AD. Exercise Progression Protocol for Lung Transplant GO: A Multicomponent Telerehab Exercise Intervention for Patients After Lung Transplantation. Cardiopulm Phys Ther J. 2023 Jan;34(1):2-12. doi: 10.1097/CPT.0000000000000203. Epub 2022 Mar 23. No abstract available.'}, {'pmid': '34282853', 'type': 'DERIVED', 'citation': 'Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.'}, {'pmid': '33887443', 'type': 'DERIVED', 'citation': 'Moon SJE, Dabbs AD, Hergenroeder AL, Vendetti ML, Jones KB, Willey BM, Morrell MR, Imes CC. Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic. Contemp Clin Trials. 2021 Jun;105:106407. doi: 10.1016/j.cct.2021.106407. Epub 2021 Apr 20.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36644217/', 'label': 'Exercise Progression Protocol for LTGO'}]}, 'descriptionModule': {'briefSummary': "Estimated costs, from thirty days prior to lung transplant up through six months post surgery, exceed 1 million dollars per patient and routine medical costs average approximately fifty thousand dollars per year thereafter. Prior to transplant, lung transplant recipients self restrict activity due to severe respiratory limitations, resulting in reduced muscle mass and qualitative changes in large skeletal muscles. After transplant, despite improved lung function, studies consistently report that lung recipients fail to reach predicted physical function and physical activity. Nearly seventy percent are at risk of developing hypertension within the first five years due to side effects of immunosuppression and an inactive lifestyle worsens this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage lung recipients in self management of exercise and adopt an active lifestyle. Lung Transplant Go LTGO is a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching delivered in the recipient's home. Exercise training will focus on assisting lung recipients to learn and practice exercises to reverse muscle conditioning. Behavioral coaching will assist them to develop the skills to self manage physical activity in daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self-monitoring, feedback and problem solving.", 'detailedDescription': 'This is a two-group randomized controlled trial (RCT) comparing LTGO to enhanced usual care (EUC). Based on estimations using a published RCT, effect sizes measured by Cohen\'s d ranged from 0.64 to 1.45 across outcome variables (i.e., 0.64 for physical function; 0.73-0.99 for physical activity; and 1.19 and1.45 for systolic and diastolic BP with 80% power, α=0.05). With a final sample of 80 subjects (40 per group) we will have 80% power to detect an effect size as small as 0.64 (α=0.05, two-tailed) from independent sample t-test for measures of physical function, physical activity and hypertension onset/control. Recruiting and randomizing 112 individuals (56 in LTGO \\& 56 in EUC) will allow for up to 30% attrition. Participants will be randomized to LTGO or EUC (1:1). The biostatistician will randomize participants using a blocked randomization scheme, stratified by sex (male vs. female) and length of hospital stay (≤2 wks vs.\\>2 wks). The block size (2 or 4) will be randomly selected to prevent prediction of group assignment. An "intention-to-treat" (ITT) approach will be used. All subjects will be analyzed in the group to which they were randomly assigned, regardless of adherence to the protocol, treatment received, and/or withdrawal from the protocol. Endorsed by international regulatory guidelines, the ITT approach is widely used in RCT because it minimizes the potential for the introduction of biases into data analysis and maintains prognostic balance generated from original random treatment allocation. Although the ITT approach is recommended for efficacy analysis in RCTs, the sensitivity of the results assumes that ITT will be explored using information collected regarding fidelity and dosage (e.g., number of sessions completed).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n\n -\\>4 weeks after the participant had lung transplant surgery\n* Discharged from the hospital after your lung transplant surgery\n* MD report of difficulty walking ¼ mile or climbing 10 steps without resting\n* Medical monitor approves patient eligibility for participation\n\nExclusion Criteria:\n\n* concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period with no plans to stop formal exercise\n* having other chronic conditions that may severely limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments\n* does not have home internet or smart device with Bluetooth capabilities\n* medical issue precluding participation\n* declining to be asked screening questions, or declining an introduction to the research team to hear about research\n* greater than 18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)'}, 'identificationModule': {'nctId': 'NCT03728257', 'acronym': 'LTGO', 'briefTitle': 'Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation', 'orgStudyIdInfo': {'id': 'STUDY19020357'}, 'secondaryIdInfos': [{'id': '1R01NR017196-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR017196-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTGO-Home Based Exercise', 'description': 'The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation.', 'interventionNames': ['Behavioral: LTGO-Home Based Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.', 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'LTGO-Home Based Exercise', 'type': 'BEHAVIORAL', 'description': 'The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, Versatile and Integrated System for Tele-Rehabilitation (VISYTER)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement', 'armGroupLabels': ['LTGO-Home Based Exercise']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'description': 'Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, School of Nursing', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Annette DeVito Dabbs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman', 'investigatorFullName': 'Annette DeVito Dabbs, PhD, RN', 'investigatorAffiliation': 'University of Pittsburgh'}}}}