Recruiting

Fall Prevention

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06363942

Conditions

Fall Injury

Frailty

Old Age; Atrophy

Age-Related Atrophy

Age-Related Sarcopenia

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

Interventions

SAFE program (exercise intervention)

Study Details

Brief 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.

Conditions

Fall Injury

Frailty

Old Age; Atrophy

Age-Related Atrophy

Age-Related Sarcopenia

Study ID

NCT06363942

Start date

Jul 1, 2024

Status verified date

Jul, 2024

Completion date

Apr 15, 2026

Anticipated

Primary completion date

Apr 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: SAFE program

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.

no intervention: Control group

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

Interventions

SAFE program (exercise intervention)

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.

Primary outcome measure

  • Objective 1 [ Time Frame: 12 weeks ]
  • Objective 2 [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Guy Hajj Boutros

514-501-9975guyelhajj@gmail.com

Locations

Royal Victoria Hospital - Glen site

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Guy Hajj Boutros

514-8934-1934guyelhajj@gmail.com

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jul 12, 2024

Last verified

Jul, 2024

Keywords

  • frailty
  • exercise
  • older adult
  • ageing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-07-12.