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

McGill University

Status: Enrolling

Conditions: Fall Injury; Age-Related Sarcopenia; Age-Related Atrophy; Old Age; Atrophy; Frailty

Treatments: Other: SAFE program (exercise intervention)

Study type: Interventional

Funder types: Other

Identifiers

NCT06363942

2024-5973

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Considered Frail or Pre frail according to Fried's criteria

Exclusion criteria

• 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,
• Heart disease, history of heart attacks or electrocardiogram abnormalities
• Any family history of thrombosis, thrombosis risk,
• hypocalcaemia,
• uric acidemia,
• orthostatic intolerance,
• vestibular disorders,
• considerable musculoskeletal issues,
• chronic back pain,
• head trauma,
• seizures,
• ulcers,
• renal stones,
• gastro-esophageal reflux disease,
• renal function disorder,
• hiatus hernia,
• migraines,
• mental illness diagnosis
• prescribed medication that may interfere with the interpretation of the results

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

SAFE program

Experimental group

Description:

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.

Treatment:

Other: SAFE program (exercise intervention)

Control group

No Intervention group

Description:

Participants will be asked to continue their activities of daily living without making any changes.