Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 11:05 PM
Study NCT ID:
NCT06886256
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation for Kidney Transplant Candidates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.', 'timeFrame': 'Day 1', 'description': 'Moderate intensity exercise is defined as a score of 3-5 on the Modified BORG CR10 Rating Perceived Exertion (RPE)'}], 'secondaryOutcomes': [{'measure': 'Muscle strength - Grip strength', 'timeFrame': 'Baseline', 'description': 'hand-held dynamometer, Newtons; Measures upper body strength'}, {'measure': 'Muscle strength - Chair stand test', 'timeFrame': 'Baseline', 'description': 'Number of times from chair sitting to standing in 30 seconds; Measures lower body strength and balance'}, {'measure': 'Physical performance - Gait speed', 'timeFrame': 'Baseline', 'description': 'meters per second; Measures walking speed over a short distance'}, {'measure': 'Physical performance - Timed up and go', 'timeFrame': 'Baseline', 'description': 'seconds; time to stand up from a chair, walk a short distance, turn around, walk back to the chair, and sit down; Assess mobility and balance'}, {'measure': 'Physical performance - Walking test, 6-minute walk', 'timeFrame': 'Baseline', 'description': '6-minute walk distance, meters; If the test is not available a 5-meter test can be used'}, {'measure': 'Physical performance - Walking test, 5-meter walk', 'timeFrame': 'Baseline', 'description': '5-meter test, seconds; If the 6-minute walk test is not available a 5-meter test can be used'}, {'measure': 'Respiratory capacity - Maximal inspiratory pressure', 'timeFrame': 'Baseline', 'description': 'Record in units of cmH20; Measure of strength of inspiratory muscles'}, {'measure': 'Respiratory capacity - Adjust Inspiratory Muscle Trainer completion', 'timeFrame': 'Baseline', 'description': 'A binary assessment of whether the inspiratory muscle trainer required adjustment'}, {'measure': 'Physical therapy - Aerobic exercise', 'timeFrame': 'Day 1', 'description': 'Rate of perceived exertion as measured by Modified BORG CR10 Rating Perceived Exertion (RPE) scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).'}, {'measure': 'Physical therapy - Resistance exercise', 'timeFrame': 'Day 1', 'description': 'Rate of perceived exertion as measured by Modified BORG CR10 Rating Perceived Exertion (RPE) scale of 0 (no exertion or resting) to 10 (pushing yourself to the max).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'Frailty', 'Chronic Kidney Insufficiency'], 'conditions': ['Kidney Transplantation', 'Frailty', 'Chronic Kidney Insufficiency']}, 'referencesModule': {'references': [{'pmid': '32573816', 'type': 'BACKGROUND', 'citation': 'Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.'}, {'type': 'BACKGROUND', 'citation': 'Yamagami M, Mack K, Mankoff J, Steele KM. "I\'m Just Overwhelmed": Investigating Physical Therapy Accessibility and Technology Interventions for People with Disabilities and/or Chronic Conditions. ACM Transactions on Accessible Computing. 2022;15(4):1-22. doi: doi.org/10.1145/3563396.'}]}, 'descriptionModule': {'briefSummary': 'This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.', 'detailedDescription': 'This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney transplant candidates who meet criteria for the study will have wearable sensors placed for monitoring during the exercise session of their prehabilitation. The sensors will capture data during the single exercise session and transfer the data to a mobile health (mHealth) platform. The study aims to use the information from the sensors to develop future studies where the exercise is adjusted based on the sensor reports.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital\n2. Male or Female, aged 55 or older\n3. Provision of signed and dated informed consent by the participant\n4. Willingness to comply with study procedures and the duration of the study\n\nExclusion Criteria:\n\n1. Inability or contraindication to exercise\n2. Refusal to participate\n3. Inability to consent or effectively communicate'}, 'identificationModule': {'nctId': 'NCT06886256', 'briefTitle': 'Prehabilitation for Kidney Transplant Candidates', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail', 'orgStudyIdInfo': {'id': 'PRO00038084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Each participant will have 3 wearable sensors placed during a single exercise event. The data collected from the sensors will be transferred to a mHealth platform for monitoring feasibility.', 'interventionNames': ['Device: Polar H10 Heart Rate Monitor', 'Device: Empatica EmbracePlus', 'Device: Apple Watch Ultra 2']}], 'interventions': [{'name': 'Polar H10 Heart Rate Monitor', 'type': 'DEVICE', 'description': 'Wearable sensors to capture movement-based data during physical therapy session. The Polar H10 Heart Rate Monitor measures heart rate and will transfer the data to the mHealth app.', 'armGroupLabels': ['Intervention']}, {'name': 'Empatica EmbracePlus', 'type': 'DEVICE', 'description': 'Wearable sensors to capture movement-based data during physical therapy session. The Empatica EmbracePlus measures physiological parameters and will transfer the data to the mHealth app.', 'armGroupLabels': ['Intervention']}, {'name': 'Apple Watch Ultra 2', 'type': 'DEVICE', 'description': 'Wearable sensors to capture movement-based data during physical therapy session. The Apple Watch Ultra 2 measures heart rate, will transfer the data to the mHealth app, and will provide an alert when the heart rate is too high or too low.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darrel Cleere, BSN', 'role': 'CONTACT', 'email': 'dwcleere@houstonmethodist.org', 'phone': '713-441-6232'}, {'name': 'Shondra Word', 'role': 'CONTACT', 'email': 'sword@houstonmethodist.org', 'phone': '713-441-5122'}, {'name': 'Atiya Dhala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital System', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Darrel Cleere, BSN CCRP', 'role': 'CONTACT', 'email': 'dwcleere@houstonmethodist.org', 'phone': '713-441-6232'}, {'name': 'Linda W Moore, PhD CCRP', 'role': 'CONTACT', 'email': 'lwmoore@houstonmethodist.org', 'phone': '713-441-6144'}], 'overallOfficials': [{'name': 'Atyia Dhala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing will be available from this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Medicine in Clinical Surgery', 'investigatorFullName': 'Atiya Dhala', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}