Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02963558
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2016-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Promoting Critical Illness Recovery in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dfiles@wakehealth.edu', 'phone': '336-716-8898', 'title': 'D Clark Files, MD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'through hospital discharge (an average of 10 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'exacerbation of underlying condition resulting in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 hours after randomization', 'description': 'Feasibility will be assessed by quantifying the ability to apply the MOTOmed device for at least a 15-minute session within 48 hours of randomization and meeting safety criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only pertains to the interventional arm.'}, {'type': 'SECONDARY', 'title': 'Short Physical Performance Battery (SPPB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Intensive Care Unit (ICU) discharge (through study completion, on average day 10)', 'description': 'Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores range from 0-12. A higher score denotes a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Physical Performance Battery (SPPB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '4.25', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (through study completion, on average day 10)', 'description': 'Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Score ranges from 0 to 12. A higher score denotes a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Handgrip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '11.33', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18.6'}, {'value': '11.33', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '21.33'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '14.33', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '8.67', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'ICU Discharge, Hospital discharge (through study completion, on average day 10)', 'description': 'Assessed with a Jamar hand-held dynamometer.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mobility Assessment Tool-short Form (MAT-sf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '64.7'}, {'value': '49.12', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '62.3'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '48.1'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '49.1', 'upperLimit': '62.1'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '46.9'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0, ICU discharge, Hospital discharge', 'description': 'A scoring system from 30 to 80 with 80 meaning higher physcial function', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Hospital discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '16.75', 'upperLimit': '22.0'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '23.5'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'hospital discharge, month 3, month 6', 'description': 'screening instrument for mild cognitive dysfunction; range 0-30; lower score means more cognitive impairment', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not adminstered at month 3 and month 6; no data collected for those time frames'}, {'type': 'SECONDARY', 'title': 'Quad Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18.9'}, {'value': '12.37', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '22.4'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20.03'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'ICU Discharge, Hospital discharge', 'description': 'Measurement of quadriceps strength while sitting.', 'unitOfMeasure': 'newtons', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Short Form-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '45'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '20'}]}]}, {'title': 'Role Limited Due to Physical Health', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Energy/Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.33', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '66.67'}]}]}, {'title': 'Emotional Well-Being', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '76'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37.5'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '55'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '77.5'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '60'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'hospital discharge', 'description': 'Assesses quality of life. Score for each part of the questionnaire ranges from 0 to 100. Data will be collected for the following parts: Physical functioning, Role Limited Due to Physical Health, Role Limited Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, General Health. For each of these a higher score means better function/less impariment in regards to each item.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only completed at hospital discharge; data not collected at any other time frame'}, {'type': 'SECONDARY', 'title': 'Muscle Ultrasound--tibialis Anterior Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '103'}, {'value': '102', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '104'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '102'}, {'value': '102', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '102'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '110'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '103'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '110'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the tibialis anterior. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.', 'unitOfMeasure': 'percentage of starting amount', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Ultrasound--echogenicity in the Tibialis Anterior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '76.07', 'spread': '24.50', 'groupId': 'OG000'}, {'value': '74.94', 'spread': '24.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '74.98', 'spread': '24.64', 'groupId': 'OG000'}, {'value': '73.62', 'spread': '24.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '78.03', 'spread': '26.20', 'groupId': 'OG000'}, {'value': '74.78', 'spread': '24.90', 'groupId': 'OG001'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '75.89', 'spread': '25.06', 'groupId': 'OG000'}, {'value': '73.31', 'spread': '24.62', 'groupId': 'OG001'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '75.22', 'spread': '25.75', 'groupId': 'OG000'}, {'value': '73.30', 'spread': '22.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Ultrasound--muscle Depth Quadriceps', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '110'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '113'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '109'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '87'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '94'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '87'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '104'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the quadriceps. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.', 'unitOfMeasure': 'percent of starting amount', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '105'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '119'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '113'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '95'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '83'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '88'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '93'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '103'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the rectus femoris. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.', 'unitOfMeasure': 'percent of starting amount', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '73.34', 'spread': '23.45', 'groupId': 'OG000'}, {'value': '70.41', 'spread': '23.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '74.34', 'spread': '25.73', 'groupId': 'OG000'}, {'value': '67.73', 'spread': '27.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '71.78', 'spread': '24.38', 'groupId': 'OG000'}, {'value': '69.01', 'spread': '23.29', 'groupId': 'OG001'}]}]}, {'title': 'ICU Discharge', 'categories': [{'measurements': [{'value': '72.06', 'spread': '26.03', 'groupId': 'OG000'}, {'value': '64.50', 'spread': '24.05', 'groupId': 'OG001'}]}]}, {'title': 'Hospital Discharge', 'categories': [{'measurements': [{'value': '68.27', 'spread': '25.39', 'groupId': 'OG000'}, {'value': '63.62', 'spread': '23.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Accelerometer Activity Monitoring Results', 'timeFrame': 'Up through two weeks after discharge', 'description': 'Used to determine activity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Hospital Readmissions', 'timeFrame': 'up to 6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Emergency Department Visits', 'timeFrame': 'up to 6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Ventilator Free Days', 'timeFrame': 'Up to 28 days from hospital admission or hospital discharge, whichever is first', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Translational Outcomes', 'timeFrame': 'up to 6 months', 'description': 'MuRF1, NFKB, myofiber size and type, etc', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Length of Stay', 'timeFrame': 'Hospital discharge (through study completion, on average day 10)', 'description': 'Number of days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality', 'timeFrame': 'up through 6 months post-discharge', 'description': 'total number affected', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intensive Care Unit (ICU) Length of Stay', 'timeFrame': 'ICU discharge (through study completion, on average day 7)', 'description': 'Number of days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawn by investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\ncycle ergometry: The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling."}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '70'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '64.5', 'upperLimit': '72.5'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '61.25', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', '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': '0', 'groupId': 'BG001'}, {'value': '0', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-21', 'size': 622576, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-18T13:30', 'hasProtocol': True}, {'date': '2022-05-31', 'size': 229520, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-18T13:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2016-11-07', 'resultsFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-17', 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accelerometer Activity Monitoring Results', 'timeFrame': 'Up through two weeks after discharge', 'description': 'Used to determine activity.'}, {'measure': 'Number of Hospital Readmissions', 'timeFrame': 'up to 6 months'}, {'measure': 'Number of Emergency Department Visits', 'timeFrame': 'up to 6 months'}, {'measure': 'Number of Ventilator Free Days', 'timeFrame': 'Up to 28 days from hospital admission or hospital discharge, whichever is first'}, {'measure': 'Translational Outcomes', 'timeFrame': 'up to 6 months', 'description': 'MuRF1, NFKB, myofiber size and type, etc'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Hospital discharge (through study completion, on average day 10)', 'description': 'Number of days'}, {'measure': 'Mortality', 'timeFrame': 'up through 6 months post-discharge', 'description': 'total number affected'}, {'measure': 'Intensive Care Unit (ICU) Length of Stay', 'timeFrame': 'ICU discharge (through study completion, on average day 7)', 'description': 'Number of days'}], 'primaryOutcomes': [{'measure': 'Number of Patients in the Intervention Arm Who Are Able to Undergo a Cycling Session', 'timeFrame': 'up to 48 hours after randomization', 'description': 'Feasibility will be assessed by quantifying the ability to apply the MOTOmed device for at least a 15-minute session within 48 hours of randomization and meeting safety criteria.'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Intensive Care Unit (ICU) discharge (through study completion, on average day 10)', 'description': 'Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Scores range from 0-12. A higher score denotes a better outcome.'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Hospital discharge (through study completion, on average day 10)', 'description': 'Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Score ranges from 0 to 12. A higher score denotes a better outcome.'}, {'measure': 'Handgrip Strength', 'timeFrame': 'ICU Discharge, Hospital discharge (through study completion, on average day 10)', 'description': 'Assessed with a Jamar hand-held dynamometer.'}, {'measure': 'Mobility Assessment Tool-short Form (MAT-sf)', 'timeFrame': 'Day 0, ICU discharge, Hospital discharge', 'description': 'A scoring system from 30 to 80 with 80 meaning higher physcial function'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'hospital discharge, month 3, month 6', 'description': 'screening instrument for mild cognitive dysfunction; range 0-30; lower score means more cognitive impairment'}, {'measure': 'Quad Strength', 'timeFrame': 'ICU Discharge, Hospital discharge', 'description': 'Measurement of quadriceps strength while sitting.'}, {'measure': 'Short Form-36', 'timeFrame': 'hospital discharge', 'description': 'Assesses quality of life. Score for each part of the questionnaire ranges from 0 to 100. Data will be collected for the following parts: Physical functioning, Role Limited Due to Physical Health, Role Limited Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, General Health. For each of these a higher score means better function/less impariment in regards to each item.'}, {'measure': 'Muscle Ultrasound--tibialis Anterior Depth', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the tibialis anterior. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.'}, {'measure': 'Muscle Ultrasound--echogenicity in the Tibialis Anterior', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.'}, {'measure': 'Muscle Ultrasound--muscle Depth Quadriceps', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the quadriceps. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.'}, {'measure': 'Muscle Ultrasound--muscle Size CSA of Rectus Femoris Muscle', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'The study team is measuring the percentage of the size of the cross-sectional area of the rectus femoris. Day 0 for everyone is 100% (starting point). The study team is measuring the percentage of that starting point at other time points.'}, {'measure': 'Muscle Ultrasound--echogenicity in the Rectus Femoris Muscle', 'timeFrame': 'day 0, day 3, day 5, ICU discharge, Hospital Discharge', 'description': 'Obtain preliminary data to estimate the treatment effect size. Echogenicity is a measure called the "grey scale measure". Scores range from 0-255. A higher score is brighter/more white on ultrasound. A lower score is darker. Think of this as exposure on a black and white picture.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome', 'Critical Illness', 'Critical Care']}, 'referencesModule': {'references': [{'pmid': '21470008', 'type': 'BACKGROUND', 'citation': 'Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.'}, {'pmid': '26974173', 'type': 'BACKGROUND', 'citation': 'Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, Santos CD, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Cameron JI; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. The RECOVER Program: Disability Risk Groups and 1-Year Outcome after 7 or More Days of Mechanical Ventilation. Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. doi: 10.1164/rccm.201512-2343OC.'}, {'pmid': '11777361', 'type': 'BACKGROUND', 'citation': 'Ely EW, Wheeler AP, Thompson BT, Ancukiewicz M, Steinberg KP, Bernard GR. Recovery rate and prognosis in older persons who develop acute lung injury and the acute respiratory distress syndrome. Ann Intern Med. 2002 Jan 1;136(1):25-36.'}, {'pmid': '18596631', 'type': 'BACKGROUND', 'citation': 'Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.'}, {'pmid': '19446324', 'type': 'BACKGROUND', 'citation': 'Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.'}, {'pmid': '23883525', 'type': 'BACKGROUND', 'citation': 'Denehy L, Skinner EH, Edbrooke L, Haines K, Warrillow S, Hawthorne G, Gough K, Hoorn SV, Morris ME, Berney S. Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up. Crit Care. 2013 Jul 24;17(4):R156. doi: 10.1186/cc12835.'}, {'pmid': '26651376', 'type': 'BACKGROUND', 'citation': 'Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel SK, Warner ML, Kriekels W, McNulty M, Fairclough DL, Schenkman M. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure. Am J Respir Crit Care Med. 2016 May 15;193(10):1101-10. doi: 10.1164/rccm.201505-1039OC.'}, {'pmid': '19623052', 'type': 'BACKGROUND', 'citation': 'Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.'}, {'pmid': '25761888', 'type': 'BACKGROUND', 'citation': "Files DC, Liu C, Pereyra A, Wang ZM, Aggarwal NR, D'Alessio FR, Garibaldi BT, Mock JR, Singer BD, Feng X, Yammani RR, Zhang T, Lee AL, Philpott S, Lussier S, Purcell L, Chou J, Seeds M, King LS, Morris PE, Delbono O. Therapeutic exercise attenuates neutrophilic lung injury and skeletal muscle wasting. Sci Transl Med. 2015 Mar 11;7(278):278ra32. doi: 10.1126/scitranslmed.3010283."}, {'pmid': '25867659', 'type': 'BACKGROUND', 'citation': 'Walsh TS, Salisbury LG, Merriweather JL, Boyd JA, Griffith DM, Huby G, Kean S, Mackenzie SJ, Krishan A, Lewis SC, Murray GD, Forbes JF, Smith J, Rattray JE, Hull AM, Ramsay P; RECOVER Investigators. Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial. 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Ann Am Thorac Soc. 2015 Feb;12(2):209-15. doi: 10.1513/AnnalsATS.201410-480OC.'}, {'pmid': '25309124', 'type': 'BACKGROUND', 'citation': 'Jolley SE, Regan-Baggs J, Dickson RP, Hough CL. Medical intensive care unit clinician attitudes and perceived barriers towards early mobilization of critically ill patients: a cross-sectional survey study. BMC Anesthesiol. 2014 Oct 1;14:84. doi: 10.1186/1471-2253-14-84. eCollection 2014.'}, {'pmid': '24040200', 'type': 'BACKGROUND', 'citation': 'Camargo Pires-Neto R, Fogaca Kawaguchi YM, Sayuri Hirota A, Fu C, Tanaka C, Caruso P, Park M, Ribeiro Carvalho CR. Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One. 2013 Sep 9;8(9):e74182. doi: 10.1371/journal.pone.0074182. eCollection 2013.'}, {'pmid': '26318234', 'type': 'BACKGROUND', 'citation': 'Kho ME, Martin RA, Toonstra AL, Zanni JM, Mantheiy EC, Nelliot A, Needham DM. Feasibility and safety of in-bed cycling for physical rehabilitation in the intensive care unit. J Crit Care. 2015 Dec;30(6):1419.e1-5. doi: 10.1016/j.jcrc.2015.07.025. Epub 2015 Jul 29.'}, {'pmid': '24768534', 'type': 'BACKGROUND', 'citation': 'Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.'}, {'pmid': '20382284', 'type': 'BACKGROUND', 'citation': 'Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.'}]}, 'descriptionModule': {'briefSummary': 'This proposal will test the hypothesis that EARLY application of a novel early rehabilitation therapy in critically ill patients will improve functional outcomes, and change the functional trajectory of this population. A pilot study of early mobilization with a cycle ergometer will be performed and translate into humans the pre-clinical mechanisms that may mediate the effects of early mobility. A second phase of the study was added in September 2019, which will focus on clinical outcomes.', 'detailedDescription': "Patients will be randomized to intervention or control groups. Patients will receive therapies according to their group assignment until hospital discharge or day 28, whichever comes first.\n\nThe intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. In-bed cycle ergometry has been shown to be safe and feasible in the critically ill and is approved for use in this population. Subjects enrolled in the intervention arm will be screened at least 5 days per week to evaluate if they meet pre-defined safety criteria based on other studies of early mobilization and cycling in the Intensive Care Unit (ICU). Patients will be positioned in the semi-recumbent position for cycling as per ICU guidelines. The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The investigators will start with passive cycling and the patient may progress to active-assisted and active cycling. The goal duration of cycling will be 30 minutes. Subjects will receive in-bed cycling at least 5 times per week for the duration of the ICU stay or until day 14, whichever comes first. During cycling and therapy sessions, the physical therapist will also complete a case report form noting vital signs, level of mobilization, and other safety measures.\n\nIn addition to cycling, the intervention arm will receive early physical therapy (PT). This physical therapy will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that were previously developed. Patients will receive 30 minutes of Physical Therapy (PT) at least 5 times per week when they are conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through the different levels of PT with an emphasis on ambulation.\n\nPhysical therapy for the intervention arm patients will continue while hospitalized through day 28. Outpatient therapy will be provided at the discretion of the patient's treating physicians.\n\nThe control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their physicians."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥55 years old\n* Admission to Wake Forest Baptist Medical Center Medical Intensive Care Unit\n* Acute Hypoxic respiratory failure on mechanical ventilation for \\<48 hours with a P:F ratio of \\<300 (or equivalent S:F ratio)\n* Previously Functional (over past 3 months, as reported by proxy):\n\nPhysical Function: Able to walk 4 m (with or without assistive device)\n\nExclusion Criteria:\n\n* Neuromuscular Disease\n* Cardiopulmonary Arrest with return of spontaneous circulation \\<6 hrs\n* Palliative Goals of Care; witholding life-sustaining therapy\n* Elevated Intracranial Pressure (\\>20 mm Hg)\n* BMI\\>45; absolute weight \\>= 150 kg\n* Inability to cycle (including absent limbs, body length \\<1.5m, body habitus not fitting the cycle, inflammatory arthritis, significant joint problems including inability to bend arms/legs; pelvic and/or LE fracture, LE bypass surgery)\n* Pregnancy\n* Unable to speak English\n* Use of continuous neuromuscular blockade\n* Temporary Pacemaker or Swan Ganz catheter or femoral ECMO catheter/IABP\n* Rhabdomyolysis with most recent CK \\>5000\n* Clinical diagnosis of dementia on medication\n* Moribund\n* Possible Exclusion: If the patient is on spine precautions, a discussion with the spine team will be necessary to determine eligibility for the study'}, 'identificationModule': {'nctId': 'NCT02963558', 'acronym': 'ASPIRE', 'briefTitle': 'A Study Promoting Critical Illness Recovery in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly', 'orgStudyIdInfo': {'id': 'IRB00039558'}, 'secondaryIdInfos': [{'id': '5UL1TR001420-03', 'link': 'https://reporter.nih.gov/quickSearch/5UL1TR001420-03', 'type': 'NIH'}, {'id': '1R03AG060076', 'link': 'https://reporter.nih.gov/quickSearch/1R03AG060076', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.", 'interventionNames': ['Device: cycle ergometry']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.'}], 'interventions': [{'name': 'cycle ergometry', 'type': 'DEVICE', 'otherNames': ['MOTOmed'], 'description': 'The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'D. Clark Files, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}