Frailty Clinical Trial - A Personalized Video-based Exercise Program for

Status Not yet recruiting

Clinical Trial Summary

This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

Clinical Trial Description

For this study, the investigators will recruit 100 frail men and women aged 75 and over from the greater Montreal area. Enrolled participants will have 4 visits at their residence. The first visit, is a screening visit, the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program. The third visit will be a virtual visit, by phone call, and the final visit will be a post-intervention assessment of cognition and functional abilities. Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living (ADLs) without any changes. Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes. Before and after the 12-week intervention, all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength, functional capacities, cognitive abilities and quality of life. At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06363942
Study type	Interventional
Source	McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact	Guy Hajj Boutros
Phone	514-501-9975
Email	guyelhajj@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	April 15, 2024
Completion date	April 15, 2026

View Details

See also
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Completed	`NCT01126723` - Effects of Tai Chi on Frailty in Elderly Adults	N/A
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Active, not recruiting	`NCT05961319` - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
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Completed	`NCT04956705` - Vitamin D and Calcium Supplementation at Danish Nursing Homes	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms