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

April 10, 2024 updated by: Jose Morais, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital - Glen site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
No Intervention: Control group
Participants will be asked to continue their activities of daily living without making any changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective 1
Time Frame: 12 weeks
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.
12 weeks
Objective 2
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective 4
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-5973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Upon completion of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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