An interventional study of SAFE program (exercise intervention) in Fall Injury, Frailty and Old Age; Atrophy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Prevention
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.
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.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be asked to carry out the SAFE program with the help of a caregiver. Our healthcare professionals will visit them during the first week to explain to them and their caregivers how to perform the exercises correctly while using our website. All exercises will be performed using video capsules available on our website (https://safe-seniors.com/fr). The exercises are divided into 4 levels of difficulty: level 1 (light); level 2 (moderate); level 3 (moderate to vigorous); and level 4 (vigorous). Each level lasts 25 to 30 minutes and includes 5 exercise categories split into 5 videos: warm-up, strength, balance, flexibility, and endurance. The exercise intervention will include 3 sessions per week over 12 weeks.
Other: SAFE program (exercise intervention)
Participants will be asked to continue their activities of daily living without making any changes.
Participants will be asked to carry out the SAFE program with the help of a caregiver. Our healthcare professionals will visit them during the first week to explain to them and their caregivers how to perform the exercises correctly while using our website. All exercises will be performed using video capsules available on our website (https://safe-seniors.com/fr). The exercises are divided into 4 levels of difficulty: level 1 (light); level 2 (moderate); level 3 (moderate to vigorous); and level 4 (vigorous). Each level lasts 25 to 30 minutes and includes 5 exercise categories split into 5 videos: warm-up, strength, balance, flexibility, and endurance. The exercise intervention will include 3 sessions per week over 12 weeks.
Objective 1
Number of participants that displayed changes on their functional testing (SPPB) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.
Time frame: 12 weeks
Objective 2
Number of participants that displayed changes on their cognitive (STROOP) in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.
Time frame: 12 weeks
Objective 4
Number of participants that displayed changes on their FES-I test in comparison with their baseline and the control group after having participated in the SAFE program, following the 12 week intervention.
Time frame: 12 weeks
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
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McGill University Health Centre/Research Institute of the McGill University Health Centre