RecruitingNAINTERVENTIONAL

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

This study is investigating a personalised video-based exercise programme, called SAFE, designed to help older adults who are frail or becoming frail, reduce their risk of falling. We know that as people get older, their muscles can weaken, increasing the chance of falls. The study will involve 100 people aged 75 and over from the Montreal area. Half of them will do the SAFE exercises at home three times a week for 12 weeks, while the other half will continue their normal daily activities. Researchers will check muscle strength, movement, thinking skills, and quality of life before and after the exercise programme. After the study, everyone will have the chance to try the exercises.

At a glance

Status

Recruiting

Phase

Sponsor

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

Enrolment target

100

Start

01 Jul 2024

Estimated completion

15 Apr 2026

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

What is this study about?

As we get older, it's common for our muscles to become weaker, which can make us less steady and increase our chances of falling. Falls can lead to serious injuries and can affect our independence. This study is looking into a special exercise programme called SAFE (which stands for something like Stay Active, Feel Empowered) that uses videos to guide people through exercises at home. The main goal is to see if these exercises can help older people who are feeling a bit frail or are at risk of becoming frail, to become stronger, more balanced, and ultimately reduce their risk of falling.

The researchers want to find out if doing these specific exercises can make a real difference to people's health and well-being. They will compare a group of people who do the exercises with a group who don't, to understand the benefits. Both groups will have careful checks of their physical abilities, how well they can remember things, and their overall quality of life before and after the 12-week programme. This helps the researchers see if the exercises really make a positive change and if they can help people stay active and independent for longer.

This kind of study, where people are randomly put into different groups (like picking names out of a hat), is called a 'randomised interventional clinical trial'. It's a reliable way to test if a new treatment or programme works. At the end of the study, everyone involved will either be encouraged to continue the exercises or given the chance to start them, so everyone benefits in the long run. Researchers will also check in with participants by phone a few months later to see if they're still keeping up with the exercises.

Key takeaways

Study aims to prevent falls in older adults.
Uses a home-based video exercise programme (SAFE).
Involves regular home visits and one phone call.
Compares an exercise group to a non-exercise group for 12 weeks.
All participants eventually get access to the SAFE exercises.
Focuses on improving strength, balance, and quality of life.

Who may be eligible?

This study is looking for men and women aged 75 or older who live in the greater Montreal area. You might be a good fit if you're considered 'frail' or 'pre-frail'. This means you might be feeling a bit weaker, moving slower, or feeling tired more often than before.

However, there are some reasons why you wouldn't be able to join. For example, if you have a diagnosis of dementia, or if you've smoked recently (within the last 6 months). You also wouldn't be able to participate if you've had issues with drug or alcohol abuse recently, or if you have certain serious health conditions like heart disease, a history of heart attacks, or certain kidney problems.

The researchers also need to make sure that any medicines you're taking won't make it difficult to understand the study results. So, if you have a history of blood clots, very low calcium levels, certain balance problems, significant muscle or joint issues (like chronic back pain), or severe migraines, you wouldn't be able to take part. This helps ensure the study is safe for everyone and that the results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 75 years old or older?
Do you live in the greater Montreal area?
Do you feel a bit weaker or less steady than before (frail or pre-frail)?
Have you *not* smoked in the last 6 months?
Do you *not* have a diagnosis of dementia?
Do you *not* have a serious heart condition or a history of heart attacks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of 100 people in the study. You'll have four visits that take place at your home. The first visit is to check if you're suitable for the study. The second visit involves some tests to look at your thinking skills and how well you can move around, and you'll learn about the exercise programme.

After that, you'll be randomly put into one of two groups. If you're in the 'exercise group', you'll do the SAFE exercises at home three times a week for 12 weeks. You'll also continue your usual daily activities without change. If you're in the 'control group', you'll continue your normal daily activities but won't do the SAFE exercises during the 12 weeks. There will be a virtual check-in (a phone call) during this time.

At the end of the 12 weeks, you'll have a final visit at home where the researchers will repeat the physical and thinking skills tests. After this, if you were in the exercise group, you'll be encouraged to keep doing the exercises. If you were in the control group, you'll then get the chance to learn and do the SAFE exercises. Finally, about 12 weeks after the programme finishes, the researchers will call you to see if you're still doing the exercises. The total duration of active participation (before the follow-up call) is 12 weeks.

Potential risks and benefits

Taking part in this study could offer some potential benefits, especially if you're in the exercise group. The SAFE programme is designed to help improve your muscle strength, balance, and overall movement, which could reduce your risk of falls and help you feel more confident and independent. Even if you're in the control group initially, you'll get the chance to learn the exercises later. Regular exercise is generally good for your health and can improve your quality of life. As for risks, any exercise programme carries a small risk of muscle soreness or minor injury, but the exercises are designed to be safe and suitable for older adults. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Royal Victoria Hospital - Glen site
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is the SAFE programme?

It's an exercise programme based on videos, designed to help older people improve their strength and balance to prevent falls.

How long will I need to do the exercises?

If you're in the exercise group, you'll do them three times a week for 12 weeks. After the study, you'll be encouraged to continue.

Do I have to go to a clinic?

No, all your visits and the exercises will happen in your own home, with one check-in by phone.

What if I don't want to do the exercises?

If you're in the control group, you won't do the exercises during the main 12-week study period, but you'll get the chance to learn them afterwards.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

Guy Hajj Boutros

guyelhajj@gmail.com 514-501-9975 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.