Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT03704194
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bminor@wustl.edu', 'phone': '314-273-4118', 'title': 'Brittany Minor', 'organization': 'Washington university in St.louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected through a 16-week period when a participant was enrolled in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Berg Balance Scale (BBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '40.63', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '35.25', 'spread': '11.52', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '38.38', 'spread': '12.59', 'groupId': 'OG000'}, {'value': '35.88', 'spread': '9.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic balance. Performance quality, time, and assistance required are rated on a scale of 0-4 based on pre-specified criteria. Total scores range from 0-56, with a score of 45 or below indicating high risk of falls.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the intervention were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'The Self-Reported Habit Index (SRHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '47.50', 'spread': '21.67', 'groupId': 'OG000'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '57.13', 'spread': '19.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Self-Reported Habit Index (SRHI) is a 12-item assessment assesses habit exercise strength, frequency, relevance to self-identity, and automaticity. Items are self-rated with a seven-point Likert scale (1=strongly disagree, 7= strongly agree). Total score range from 12 to 84, where higher scores indicate stronger the habit is.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the treatment group were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'The Activities-specific Balance Confidence Scale (ABC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '60.77', 'spread': '20.83', 'groupId': 'OG000'}, {'value': '52.46', 'spread': '22.26', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '60.63', 'spread': '21.57', 'groupId': 'OG000'}, {'value': '60.7', 'spread': '12.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Activities-specific Balance Confidence Scale (ABC) is 16-item self-report measure in which participates rate their balance confidence for performing activities. Each item is rated on a 0-100 scale (0= no confidence, 100 = complete confidence). A final score is the average of all items ( range from 0 to 100).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the interventions were included.'}, {'type': 'SECONDARY', 'title': 'The Short Physical Performance Battery (SPPB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'Pre-test', 'categories': [{'measurements': [{'value': '6.38', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Post-test', 'categories': [{'measurements': [{'value': '5.25', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Short Physical Performance Battery-Balance Test (SPPB) assess balance and mobility with three subtests (score range: 0 to 4): standing balance, three-meter gait speed, and five repetitions of sit-to-stand motion. Total score are sums of subtest scores ranging from 0 (worst performance) to 12 (best performance).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the interventions were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Center of Pressure (CoP) Path (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'HS CoP Mean distance (cm) Pre-test', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'HS CoP Mean distance (cm) Post-test', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'HSEC CoP Mean distance (cm) Pre-test', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'HSEC CoP Mean distance (cm) Post-test', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'NS CoP Mean distance (cm) Pre-test', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'NS CoP Mean distance (cm) Post-test', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'NSEC CoP Mean distance (cm) Pre-test', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'NSEC CoP Mean distance (cm) Post-test', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Center of Pressure (Cop) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Trajectory and mean velocity of CoP in each postures are calculated to represent static balance. Larger trajectory or velocity indicates lower static balance.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the interventions were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Center of Pressure (CoP) Velocity (cm/s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'HS CoP Mean velocity (cm/s) Pre-test', 'categories': [{'measurements': [{'value': '2.38', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'HS CoP Mean velocity (cm/s) Post-tes', 'categories': [{'measurements': [{'value': '2.59', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'HSEC CoP Mean velocity (cm/s) Pre-test', 'categories': [{'measurements': [{'value': '3.22', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'HSEC CoP Mean velocity (cm/s) Post-test', 'categories': [{'measurements': [{'value': '4.01', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'NS CoP Mean velocity (cm/s) Pre-test', 'categories': [{'measurements': [{'value': '3.18', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'NS CoP Mean velocity (cm/s) Post-test', 'categories': [{'measurements': [{'value': '3.88', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'NSEC CoP Mean velocity (cm/s) Pre-test', 'categories': [{'measurements': [{'value': '4.55', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'NSEC CoP Mean velocity (cm/s) Post-test', 'categories': [{'measurements': [{'value': '5.05', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Center of Pressure (Cop) mean velocity (cm/s) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Larger velocity indicates a lower static balance.', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the interventions were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Lower Extremity Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'title': 'Hip flexors (right limb) Pre-test', 'categories': [{'measurements': [{'value': '18.11', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '19.86', 'spread': '8.95', 'groupId': 'OG001'}]}]}, {'title': 'Hip flexors (right limb) Post-test', 'categories': [{'measurements': [{'value': '18.73', 'spread': '12.55', 'groupId': 'OG000'}, {'value': '21.58', 'spread': '15.75', 'groupId': 'OG001'}]}]}, {'title': 'Hip flexors (left limb) Pre-test', 'categories': [{'measurements': [{'value': '17.10', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '15.97', 'spread': '7.67', 'groupId': 'OG001'}]}]}, {'title': 'Hip flexors (left limb) Post-test', 'categories': [{'measurements': [{'value': '19.79', 'spread': '13.23', 'groupId': 'OG000'}, {'value': '19.25', 'spread': '8.70', 'groupId': 'OG001'}]}]}, {'title': 'Knee flexors (right limb) Pre-test', 'categories': [{'measurements': [{'value': '23.83', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '24.15', 'spread': '8.91', 'groupId': 'OG001'}]}]}, {'title': 'Knee flexors (right limb) Post-test', 'categories': [{'measurements': [{'value': '16.48', 'spread': '9.51', 'groupId': 'OG000'}, {'value': '18.65', 'spread': '8.22', 'groupId': 'OG001'}]}]}, {'title': 'Knee flexors (left limb) Pre-test', 'categories': [{'measurements': [{'value': '21.34', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '23.40', 'spread': '6.66', 'groupId': 'OG001'}]}]}, {'title': 'Knee flexors (left limb) Post-test', 'categories': [{'measurements': [{'value': '15.01', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '8.77', 'groupId': 'OG001'}]}]}, {'title': 'Knee extensors (right limb) Pre-test', 'categories': [{'measurements': [{'value': '25.38', 'spread': '6.90', 'groupId': 'OG000'}, {'value': '27.38', 'spread': '7.53', 'groupId': 'OG001'}]}]}, {'title': 'Knee extensors (right limb) Post-test', 'categories': [{'measurements': [{'value': '22.62', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '27.15', 'spread': '10.84', 'groupId': 'OG001'}]}]}, {'title': 'Knee extensors (left limb) Pre-test', 'categories': [{'measurements': [{'value': '23.25', 'spread': '8.06', 'groupId': 'OG000'}, {'value': '26.56', 'spread': '6.84', 'groupId': 'OG001'}]}]}, {'title': 'Knee extensors (left limb) Post-test', 'categories': [{'measurements': [{'value': '21', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '26.81', 'spread': '11.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Lower extremity muscle strength of hip and knee are measured by a dynamometer.', 'unitOfMeasure': 'pound', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the interventions were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Recruitment and Retention Rate Are Documented by Therapist Logs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}, {'id': 'OG001', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}], 'classes': [{'title': 'Recruitment rate', 'categories': [{'measurements': [{'value': '42.02', 'groupId': 'OG000'}, {'value': '42.02', 'groupId': 'OG001'}]}]}, {'title': 'Retention rate', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'The status of each potential participant we contacted is documented in an electronic therapist log. Treatment and control groups share the same recruitment rate since randomization took place after enrollment, and the two groups were not recruited separately. Recruitment rate will be measured by the percentage of participants successfully enrolled in the study. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among 39 potentially eligible participants, 16 successfully enrolled. The 16 enrolled participants were randomized to treatment (n=8) and control (n=8)groups, and all completed the intervention and one-month follow-up, which resulted in a 100% retention rate.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptance of the Intervention Programs is Measured by a Question.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.88', 'spread': '0.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'A question, "Are you satisfied with the program?," using a seven-point Likert scale from one (very unsatisfied) to seven (very satisfied) is used to represent acceptance. Score range: 1-7. Higher values indicate higher satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completed treatment intervention were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adherence Rate is Documented by LiFE Activity Calendar', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}], 'classes': [{'title': 'Session 1', 'categories': [{'measurements': [{'value': '79', 'spread': '33', 'groupId': 'OG000'}]}]}, {'title': 'Session 2', 'categories': [{'measurements': [{'value': '87', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Session 3', 'categories': [{'measurements': [{'value': '73', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'Session 4', 'categories': [{'measurements': [{'value': '76', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Session 5', 'categories': [{'measurements': [{'value': '73', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'Session 6', 'categories': [{'measurements': [{'value': '74', 'spread': '34', 'groupId': 'OG000'}]}]}, {'title': 'Session 7', 'categories': [{'measurements': [{'value': '51', 'spread': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Participants in the treatment group documents their exercise activities in the LiFE activity calendar. Adherence rate is defined as the average percentage of exercise activities achieved during the intervention period.', 'unitOfMeasure': 'percentage of achieved exercise activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant in the treatment group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fidelity is Documented by a Visit-by-visit Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Therapists in both treatment and control group complete a checklist after every visit. The checklist consist of pre-determined key activities. The number of delivered key activities divided by the number of planned key activities in all visits calculates a fidelity score.', 'unitOfMeasure': 'percentage of treatment delivery', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completed the interventions were included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.', 'unitOfMeasure': 'counts of adverse events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completed the interventions were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'FG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAdapted LiFE: The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.'}, {'id': 'BG001', 'title': 'Attention Control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.\n\nAttention control: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '77.9', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '77.0', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'sex', 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-18', 'size': 437898, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T15:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled feasibility trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2018-09-18', 'resultsFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-07-09', 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recruitment and Retention Rate Are Documented by Therapist Logs', 'timeFrame': '16 weeks', 'description': 'The status of each potential participant we contacted is documented in an electronic therapist log. Treatment and control groups share the same recruitment rate since randomization took place after enrollment, and the two groups were not recruited separately. Recruitment rate will be measured by the percentage of participants successfully enrolled in the study. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled. Retention rate is calculated by the number of participants completed divided by the number of participants enrolled.'}, {'measure': 'Acceptance of the Intervention Programs is Measured by a Question.', 'timeFrame': '12 weeks', 'description': 'A question, "Are you satisfied with the program?," using a seven-point Likert scale from one (very unsatisfied) to seven (very satisfied) is used to represent acceptance. Score range: 1-7. Higher values indicate higher satisfaction.'}, {'measure': 'Adherence Rate is Documented by LiFE Activity Calendar', 'timeFrame': '12 weeks', 'description': 'Participants in the treatment group documents their exercise activities in the LiFE activity calendar. Adherence rate is defined as the average percentage of exercise activities achieved during the intervention period.'}, {'measure': 'Fidelity is Documented by a Visit-by-visit Checklist', 'timeFrame': '12 weeks', 'description': 'Therapists in both treatment and control group complete a checklist after every visit. The checklist consist of pre-determined key activities. The number of delivered key activities divided by the number of planned key activities in all visits calculates a fidelity score.'}, {'measure': 'Adverse Events', 'timeFrame': '16 weeks', 'description': 'Safety of the program will be evaluated by the number of adverse events documented throughout the study duration.'}], 'primaryOutcomes': [{'measure': 'The Berg Balance Scale (BBS)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Berg Balance Scale (BBS) is a 14-item assessment of static and dynamic balance. Performance quality, time, and assistance required are rated on a scale of 0-4 based on pre-specified criteria. Total scores range from 0-56, with a score of 45 or below indicating high risk of falls.'}], 'secondaryOutcomes': [{'measure': 'The Self-Reported Habit Index (SRHI)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Self-Reported Habit Index (SRHI) is a 12-item assessment assesses habit exercise strength, frequency, relevance to self-identity, and automaticity. Items are self-rated with a seven-point Likert scale (1=strongly disagree, 7= strongly agree). Total score range from 12 to 84, where higher scores indicate stronger the habit is.'}, {'measure': 'The Activities-specific Balance Confidence Scale (ABC)', 'timeFrame': '12 weeks', 'description': 'The Activities-specific Balance Confidence Scale (ABC) is 16-item self-report measure in which participates rate their balance confidence for performing activities. Each item is rated on a 0-100 scale (0= no confidence, 100 = complete confidence). A final score is the average of all items ( range from 0 to 100).'}, {'measure': 'The Short Physical Performance Battery (SPPB)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Short Physical Performance Battery-Balance Test (SPPB) assess balance and mobility with three subtests (score range: 0 to 4): standing balance, three-meter gait speed, and five repetitions of sit-to-stand motion. Total score are sums of subtest scores ranging from 0 (worst performance) to 12 (best performance).'}, {'measure': 'Center of Pressure (CoP) Path (cm)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Center of Pressure (Cop) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Trajectory and mean velocity of CoP in each postures are calculated to represent static balance. Larger trajectory or velocity indicates lower static balance.'}, {'measure': 'Center of Pressure (CoP) Velocity (cm/s)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Center of Pressure (Cop) mean velocity (cm/s) is measured by a balance board system BtracKS. Participant stands on the balance board in 4 posture in three 30-second trials for each posture: hip-width stand (HS), hip-width stand with eyes closed (HSEC), narrow stand (NS), narrow stand with eyes closed (NSEC). Larger velocity indicates a lower static balance.'}, {'measure': 'Lower Extremity Muscle Strength', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Lower extremity muscle strength of hip and knee are measured by a dynamometer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['falls', 'exercise program', 'medically underserved'], 'conditions': ['Accidental Fall']}, 'descriptionModule': {'briefSummary': 'This study will test the feasibility of a study design for the Adapted Lifestyle-integrated Functional Exercise (LiFE) program for medically underserved older adults and to explore factors related to implementation. A feasibility trial will be conducted with a total of 16 participants. The control group will receive flexibility exercise program as attention control.', 'detailedDescription': 'This study will test the feasibility the Adapted Lifestyle-integrated Functional Exercise (LiFE) program among medically underserved older adults. Sixteen medically underserved older adults will be recruited in the study and randomized to Adapted LiFE or attention control group (flexibility exercise program). Process outcomes and preliminary outcomes will be collected to determine feasibility and preliminary efficacy. Process outcomes such as reach, acceptance, adherence, fidelity, and safety will also be collected throughout the study. Preliminary efficacy outcomes include habit formation, balance, muscle strength will be collected at baseline and at immediately after intervention is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (1) age 70 or older;\n* (2) live independently;\n* (3) live in a medically underserved/health professional shortage area;\n* (4) self-report two falls or one injurious fall.\n\nExclusion Criteria:\n\n* (1) Short Blessed Test score ≥8, indicating cognitive impairment consistent with dementia;\n* (2) inability to stand independently with a walking device;\n* (3) having a serious health condition with a physician's order where exercise is contraindicated."}, 'identificationModule': {'nctId': 'NCT03704194', 'acronym': 'LiFE', 'briefTitle': 'Adapted Lifestyle-integrated Functional Exercise Program for Medically Underserved Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Adapted Lifestyle-integrated Functional Exercise Program for Older Adults in Under Resourced Communities: A Pilot Study', 'orgStudyIdInfo': {'id': '201807067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adapted LiFE', 'description': 'Participants in the Adapted LiFE group learns to imbed 19 exercise activities (7 balance and 12 lower extremity muscle strength activities) into daily routines. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.', 'interventionNames': ['Behavioral: Adapted LiFE']}, {'type': 'SHAM_COMPARATOR', 'label': 'Attention control', 'description': 'Participants in the attention control group will learn gentle stretch exercise. An Occupational Therapy practitioner conducts 7 in-home visits over 12 weeks and a follow phone call a month after the last in-home visit.', 'interventionNames': ['Behavioral: Attention control']}], 'interventions': [{'name': 'Adapted LiFE', 'type': 'BEHAVIORAL', 'description': 'The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.', 'armGroupLabels': ['Adapted LiFE']}, {'name': 'Attention control', 'type': 'BEHAVIORAL', 'description': 'Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.', 'armGroupLabels': ['Attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Susan Stark, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The results are not published yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}