About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Considered Frail or Pre frail according to Fried's criteria
Disqualifiers
Smoked within 6 months prior to study enrollment,
dementia diagnosos,
Abused drugs, medication or alcohol within up to 30 days prior to the start of the study.
drug or alcohol-addiction,
Trial design
Parallel
Treatments tested in this trial
SAFE program (exercise intervention)
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Sponsors and contacts
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