Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT04745169
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elizabeth.lorenz@bcm.edu', 'phone': '713-798-2694', 'title': 'Elizabeth Lorenz, MD', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Transient musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Short Physical Performance Battery Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '1.5'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks of home-based exercise', 'description': 'The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week score compared to baseline score'}, {'type': 'SECONDARY', 'title': 'Change in Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Grip strength will be measured using a hand-held dynamometer.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week grip strength compared to baseline'}, {'type': 'SECONDARY', 'title': 'Change in Gait Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': "Gait speed at the participant's self-selected walking speed will be measured.", 'unitOfMeasure': 'meters/second', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week gait speed compared to baseline'}, {'type': 'SECONDARY', 'title': 'Change in Exhaustion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '20.0'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Patients will self-report their level of exhaustion using the Center for Epidemiologic Studies Depression Scale (CES-D) which consists of a 4-point scale. Items on the CES-D are scored from minimum to maximum values (1 point to 4 points) which are indicated on the CES-D as "rarely or none of the time," "some or a little of the time," "occasionally or a moderate amount of time," "most or all of the time," respectively. A higher number of points indicates a worse outcome. Energy/fatigue scores on the Kidney Disease Quality of Life Short Form (KDQOL-SF) will also be calculated. Energy/fatigue scores range from 0 to 100 points with a higher number of points indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week energy/fatigue score compared to baseline score'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Energy expenditure will be measured using an activity monitor worn on the wrist for 7 days. Low activity is defined as activity in the lowest 20% (\\<383 Kcals/week for men or \\<270 Kcals/week for women). Patients will also self-report their activity level using the Minnesota Leisure Time Physical Activity Questionnaire.', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in moderate to vigorous physical activity at 8-week score compared to baseline'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-9.4', 'upperLimit': '8.4'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Health-related quality of life will be measured using the Kidney Disease Quality of Life Short Form. This questionnaire includes scales with minimum values of 0 and maximum values of 100. Higher scores indicate better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week mental health score compared to baseline score'}, {'type': 'SECONDARY', 'title': 'Change in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Weight will be measured using a scale.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week weight compared to baseline'}, {'type': 'SECONDARY', 'title': 'Change in Percent Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.3'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis.', 'unitOfMeasure': 'percentage of body fat', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week percent body fat compared to baseline'}, {'type': 'SECONDARY', 'title': 'Change in Physical Frailty Phenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Median difference in 8-week score compared to baseline score'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Kidney transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant health problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention\n\n8 week home-based exercise program: Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White race', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Dialysis dependent', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Never smoked', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'BG000', 'lowerLimit': '27.7', 'upperLimit': '37.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Physical Frailty Phenotype score', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Short Physical Performance Battery score', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-07', 'size': 148061, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-08T13:06', 'hasProtocol': True}, {'date': '2024-02-07', 'size': 3204354, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-25T18:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot study to be conducted at Baylor College of Medicine in Houston, TX examining the feasibility, safety, acceptability, and preliminary efficacy of home-based exercise on frailty parameters and SPPB score in patients with varying levels of kidney function. The effects of exercise on HRQOL, physical activity, and adverse outcomes including hospitalizations, will also be explored.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2021-01-29', 'resultsFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-14', 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Short Physical Performance Battery Score', 'timeFrame': '8 weeks of home-based exercise', 'description': 'The Short Physical Performance Battery is a composite measure which includes component tests of balance, gait speed, and chair stand time. Participants receive a score of 0-4 for each of the 3 component tests with lower scores indicating worse physical function. Component scores are then summed providing a total score of 0-12 with lower scores again indicating worse physical function.'}], 'secondaryOutcomes': [{'measure': 'Change in Grip Strength', 'timeFrame': '8 weeks', 'description': 'Grip strength will be measured using a hand-held dynamometer.'}, {'measure': 'Change in Gait Speed', 'timeFrame': '8 weeks', 'description': "Gait speed at the participant's self-selected walking speed will be measured."}, {'measure': 'Change in Exhaustion', 'timeFrame': '8 weeks', 'description': 'Patients will self-report their level of exhaustion using the Center for Epidemiologic Studies Depression Scale (CES-D) which consists of a 4-point scale. Items on the CES-D are scored from minimum to maximum values (1 point to 4 points) which are indicated on the CES-D as "rarely or none of the time," "some or a little of the time," "occasionally or a moderate amount of time," "most or all of the time," respectively. A higher number of points indicates a worse outcome. Energy/fatigue scores on the Kidney Disease Quality of Life Short Form (KDQOL-SF) will also be calculated. Energy/fatigue scores range from 0 to 100 points with a higher number of points indicating a worse outcome.'}, {'measure': 'Change in Physical Activity', 'timeFrame': '8 weeks', 'description': 'Energy expenditure will be measured using an activity monitor worn on the wrist for 7 days. Low activity is defined as activity in the lowest 20% (\\<383 Kcals/week for men or \\<270 Kcals/week for women). Patients will also self-report their activity level using the Minnesota Leisure Time Physical Activity Questionnaire.'}, {'measure': 'Change in Quality of Life', 'timeFrame': '8 weeks', 'description': 'Health-related quality of life will be measured using the Kidney Disease Quality of Life Short Form. This questionnaire includes scales with minimum values of 0 and maximum values of 100. Higher scores indicate better quality of life.'}, {'measure': 'Change in Weight', 'timeFrame': '8 weeks', 'description': 'Weight will be measured using a scale.'}, {'measure': 'Change in Percent Body Fat', 'timeFrame': '8 weeks', 'description': 'Change in percent body fat from baseline to 8 weeks was measured in the subset of participants from Mayo Clinic using bioelectrical impedance analysis.'}, {'measure': 'Change in Physical Frailty Phenotype', 'timeFrame': '8 weeks', 'description': 'The Physical Frailty Phenotype score is based on 5 criteria: unintentional weight loss, exhaustion, low physical activity, slowness, weakness. Participants receive a score of 1 for each criterion they meet. The criterion scores are then summed to provide a total score ranging from 0-5 with higher scores indicating greater frailty. Specifically, a total score of 0 indicates that the participant is not frail, a score of 1-2 indicates that the participant is pre-frail, and a score of 3-5 indicates that the participant is frail.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a pilot study to determine whether home-based exercise is an effective intervention to improve decreased physical function in kidney transplant candidates. The investigators will determine if home-based exercise improves frailty parameters and SPPB scores. The investigators will also determine if home-based exercise improves health-related quality of life (HRQOL), physical activity, and adverse clinical outcomes, including hospitalizations.', 'detailedDescription': 'Screening and Recruitment:\n\nPotential participants will be identified from dialysis units, nephrology clinics, primary care clinics, or kidney transplant clinics at Baylor College of Medicine. Patients who express interest in the study will go through the informed consent process with a member of the study team, and patients wishing to participate in the study will complete written consent. If patients have not had frailty and SPPB testing within the two weeks prior to consent, the study team member will perform frailty and SPPB testing at baseline in a supervised setting. Patients who are not frail or pre-frail and have a SPPB score \\> 10 will be ineligible for study participation.\n\nExercise Intervention:\n\nParticipants will be provided with a pedal exerciser, resistance bands, and exercise pamphlets. Participants will be asked to complete an 8-week home-based exercise program with a focus on the core components of physical activity counseling and exercise training according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. Participants will receive an individualized exercise prescription. Recommended aerobic exercises will include arm and/or leg ergometry using a pedal exerciser, and recommended resistance training will include resistance bands. During the program, participants will receive weekly semi-scripted phone calls from an exercise physiologist and gradual increases in the volume of physical activity will be recommended over time. Participants will be asked to log information regarding their exercise sessions.\n\nStudy Measures:\n\nParticipants will complete the Short Physical Performance Battery (SPPB), and Fried Frailty phenotype at baseline and after completion of the exercise intervention. The SPPB consists of gait speed, balance, and repeat chair stand tests. The Fried Frailty Phenotype consists of gait speed and grip strength tests, in addition to self-reported measurement of physical activity, weight loss, and exhaustion. Participants will also be asked to complete questionnaires and wear a physical activity monitor at baseline and after completion of the exercise intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Consenting to research\n* Chronic kidney disease (stages 1-5)\n* An SPPB score ≤10 or considered frail or pre-frail according to the Fried Frailty Phenotype\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Patients being evaluated for combined organ transplantation\n* Significant comorbidities that limit rehabilitation potential including pulmonary disease requiring continuous oxygen supplementation, active angina, critical aortic sclerosis, decompensated heart failure, or known ventricular arrhythmia.\n* An SPPB score \\>10 or not considered frail or pre-frail by the Fried Frailty Phenotype\n* Non-English speaker without availability of adequate interpreter services (safety concern)\n* Failure to pass submaximal exercise test in patients not approved for kidney transplantation at our center'}, 'identificationModule': {'nctId': 'NCT04745169', 'briefTitle': 'Home-Based Exercise to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Home-Based Exercise as an Intervention to Treat Decreased Physical Function in Patients With Varying Levels of Kidney Function', 'orgStudyIdInfo': {'id': 'H-52019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Participants will be asked to complete an 8-week home-based exercise intervention', 'interventionNames': ['Behavioral: 8 week home-based exercise program']}], 'interventions': [{'name': '8 week home-based exercise program', 'type': 'BEHAVIORAL', 'description': 'Participants will be asked to complete an 8-week home-based exercise program according to guidelines from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation. At study baseline, participants will receive exercise equipment and an individualized exercise prescription from an exercise physiologist followed by 8 weekly phone calls from an exercise physiologist. Participant safety will be monitored.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Elizabeth C Lorenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elizabeth Coite Lorenz', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}