Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT06245135
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIME™ at Home Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single: Outcomes Assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning'}], 'secondaryOutcomes': [{'measure': '7-item Berg balance scale (7BBS)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 28 points on 7-item performance-based measure'}, {'measure': '30-second sit-to-stand test (30STS)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Number of stands completed in 30 seconds'}, {'measure': "Timed 'up and go' (TUG) test", 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Time in seconds, taken to stand up from a standard armchair, walk a distance of 3 metres, turn around, walk back to the chair, and sit down again'}, {'measure': '3-metre walk test (3mWT, comfortable pace)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Comfortable walking speed in metres/second based on time taken to walk 3 metres'}, {'measure': '3-metre walk test (3mWT, fast pace)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Fast walking speed in metres/second based on time taken to walk 3 metres'}, {'measure': '2-minute step test (2ST)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Number of times the knee reaches the required height in 2 minutes'}, {'measure': 'Activities-specific balance confidence (ABC) scale', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 100 points on the 16-item self-report scale'}, {'measure': 'Center for epidemiological studies depression (CES-D) scale', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 60 points on the 20-item self-report scale'}, {'measure': 'PROMIS v2.0 Social Isolation short form', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 20 points on the 4-item self-report scale'}, {'measure': 'EuroQoL-5D-5L visual analog scale (EQ-VAS)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 100 points on the visual analog scale'}, {'measure': 'Caregiver Assistance Scale (CAS)', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 102 points on the 17-item self-report scale, completed by caregiver'}, {'measure': 'Center for epidemiological studies depression (CES-D) scale-Caregiver', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 60 points on the 20-item self-report scale, completed by caregiver'}, {'measure': 'Activities-specific balance confidence (ABC) scale-Caregiver', 'timeFrame': '0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)', 'description': 'Score from 0 to 100 points on the 16-item self-report scale, completed by caregiver'}, {'measure': 'Program delivery cost', 'timeFrame': '2 months (immediately post-intervention)', 'description': 'Cost ($) for community organizations to run the TIME at Home program in the Experimental group'}, {'measure': 'Cost ($) of exercise participation', 'timeFrame': '2 months (immediately post-intervention)', 'description': 'Cost ($) for a participant in the Experimental group to participate in the TIME at Home program'}, {'measure': 'Amount ($) willing to pay to register for TIME at Home', 'timeFrame': '2 months (immediately post-intervention)', 'description': 'Amount ($) that participants in the Experimental group would be willing to pay out-of-pocket to receive the program'}, {'measure': 'Quality-adjusted life-years (QALYs)', 'timeFrame': '2 months (immediately post-intervention)', 'description': 'Scores on the EQ-5D-5L convert to a single index value used to calculate quality-adjusted life-years (QALYs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Exercise', 'Community-based Exercise', 'Mobility', 'Balance', 'Randomized Controlled Trial'], 'conditions': ['Mobility Limitation']}, 'referencesModule': {'references': [{'pmid': '40721264', 'type': 'DERIVED', 'citation': "Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a waitlist control on increasing everyday function among adults with mobility limitations: protocol for the TIME at Home randomised controlled trial. BMJ Open. 2025 Jul 28;15(7):e102694. doi: 10.1136/bmjopen-2025-102694."}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations.\n\nThe main questions the trial aims to answer are:\n\n1. Will there be improvements in physical and mental health outcomes, and caregiver mood and assistance, following participation in the TIME™ at Home exercise program that are greater than in the waitlist control group?\n2. Will level of mobility limitation, sex, or gender influence the experiences of people in the exercise program?\n3. What will be the costs of the TIME™ at Home exercise program for the organization delivering the program, and the people who are in the exercise program?\n\nParticipants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later.\n\n* Participants will complete tests of balance and walking and questionnaires.\n* Caregivers will only complete questionnaires.\n\nAfter the first evaluation, participants will be randomly assigned to either participate in:\n\n* the 8-week TIME™ at Home exercise program from their homes using Zoom, or\n* to wait 5 months (waitlist control group) before beginning the 8-week TIME™ at Home exercise program', 'detailedDescription': "Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.\n\nThe objectives of the TIME™ at Home randomized controlled trial are:\n\n1. To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations;\n2. To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function;\n3. To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and\n4. To explore exercise participants', caregivers' and program providers' experiences during the intervention phase."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adult defined as age 18 years or older;\n2. mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);\n3. living independently in the community (in own home or assisted living settings);\n4. able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision from another person;\n5. able to stand up from and sit down onto a chair independently, without supervision;\n6. able to maintain balance while exercising in standing (e.g., marching on the spot) holding onto the back of a chair or a sturdy countertop;\n7. has a study partner (e.g., caregiver, family member or friend) willing to be present, at minimum, during the first evaluation in the home via Zoom;\n8. able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;\n\nExclusion Criteria:\n\n1. involvement in another formal exercise or rehabilitation program in the next 2 months;\n2. previous participation in the TIME at Home exercise program;\n3. health conditions or symptoms preventing participation in exercise;\n4. cognitive impairment, defined as a score of \\<11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);\n5. severe visual impairment;\n6. severe hearing impairment\n\nCaregivers\n\nInclusion criteria:\n\n1. caregiver defined as an individual who helps the exercise participant to live at home by providing support and assistance with at least one basic (e.g., self-care) and/or instrumental activity of daily living (e.g., doing groceries, cleaning, managing finances, making meals, doing laundry, etc.) at least once a week;\n2. able to speak and read English.\n\nExclusion criteria:\n\n1\\. Is a paid personal support worker.'}, 'identificationModule': {'nctId': 'NCT06245135', 'briefTitle': 'TIME™ at Home Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Short-term Effects of a Virtual, Community-based, Task-oriented Group Exercise Program Compared to a Waitlist Control in Increasing Function Among Adults With Balance and Mobility Limitations: The TIME™ at Home Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '45343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIME at Home', 'description': 'TIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom.', 'interventionNames': ['Behavioral: TIME at Home']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation.'}], 'interventions': [{'name': 'TIME at Home', 'type': 'BEHAVIORAL', 'description': 'Sessions involve a 15-minute pre-video safety check and social time; streaming a 1-hour pre-recorded exercise video; and a 15-minute post-video social time. Two trained facilitators run each class, with a maximum group size of 10 people.\n\nThe 1-hour exercise videos include a seated warm-up and cooldown, and 40 minutes of functional, self-paced exercises. In the video, 2 healthcare professionals demonstrate a lower and higher difficulty level of each exercise. The program starts with a level 1 video and switches to a level 2 video midway.\n\nA registered healthcare professional, called the healthcare partner, visits select classes and serves as a resource to participants and facilitators.', 'armGroupLabels': ['TIME at Home']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2G5', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Doyeon Hwang, MScPH', 'role': 'CONTACT', 'email': 'rehab.timestudy@ualberta.ca', 'phone': '(825) 975-4800'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E 0T6', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roheema Ewesesan, MD', 'role': 'CONTACT', 'email': 'Roheema.Ewesesan@umanitoba.ca', 'phone': '(204) 787-8015'}], 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'K1N 5C8', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Asefeh Memarian, MSc', 'role': 'CONTACT', 'email': 'amemarian@bruyere.org', 'phone': '(613) 562-6262 ext. 1419'}], 'facility': 'Bruyère Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1V7', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Renato Barbosa dos Santos, MSc', 'role': 'CONTACT', 'email': 'timestudy@utoronto.ca', 'phone': '(416) 946-7579'}, {'name': 'Nancy Salbach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Renato Barbosa dos Santos, MSc', 'role': 'CONTACT', 'email': 'timestudy@utoronto.ca', 'phone': '416-946-7579'}, {'name': 'Nancy Salbach, PhD', 'role': 'CONTACT', 'email': 'nancy.salbach@utoronto.ca', 'phone': '416-946-8558'}], 'overallOfficials': [{'name': 'Nancy Salbach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the study ends.', 'ipdSharing': 'YES', 'description': 'The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form, will be shared with qualified researchers engaging in REB-approved independent scientific research, upon request to the research team.', 'accessCriteria': 'Please contact the research team'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'March of Dimes, Canada', 'class': 'OTHER'}, {'name': 'Heart and Stroke Foundation of Canada', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'University of Manitoba', 'class': 'OTHER'}, {'name': 'Bruyère Health Research Institute.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Nancy Salbach', 'investigatorAffiliation': 'University of Toronto'}}}}