RecruitingPHASE3INTERVENTIONAL

Home-based Cycling for People With Lumbar Spinal Stenosis

This study explores if using a special at-home exercise bike can help improve back-related activity problems for people suffering from lumbar spinal stenosis. This condition causes back and leg pain, especially when standing or walking, which usually feels better when sitting. The research compares a home-based cycling program plus their usual medical care to just receiving usual care. Doctors want to see if adding home cycling makes a real difference in how much pain people experience and how easily they can do daily activities over a 4-month period. It's for people aged 50 and older who have been diagnosed with this condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

302

Start

10 Feb 2025

Estimated completion

01 Feb 2028

Symptomatic Lumbar Spinal Stenosis

What is this study about?

Lumbar spinal stenosis is a common problem, especially for older people. It happens when the spaces in your spine narrow, putting pressure on the nerves. This often leads to pain in your lower back, buttocks, and legs, particularly when you stand or walk for a while. The good news is that these symptoms usually get better when you sit down.

Because this pain can make it hard to get around and enjoy life, doctors are always looking for effective treatments. Currently, there are two main ways to treat it: conservative treatments (like physical therapy or medication) or surgery. While surgery can sometimes help a lot, it's not always the best choice for everyone, especially older people who might have other health conditions. This is why conservative treatments are usually tried first.

This study is focusing on a specific type of conservative treatment: exercise. While exercise is often recommended, there isn't a lot of strong research yet about the best exercises for lumbar spinal stenosis. Previous, smaller studies have hinted that exercises that involve bending forward, like cycling, might help with pain and how well people can move. This larger study aims to find out if a home-based cycling program, using a special exercise bike, can really make a difference for people with lumbar spinal stenosis when combined with their usual care.

Key takeaways

This study investigates home cycling for lumbar spinal stenosis.
It aims to improve daily activities for people with back and leg pain.
Compares home cycling with usual care versus usual care alone.
Participants must be 50 or older with a diagnosed condition.
The study lasts for 4 months of observation.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 50 years old and have a doctor's diagnosis of lumbar spinal stenosis. This means you experience pain in your lower back, buttocks, and/or legs when walking, which gets better when you sit or bend your back forward. Your doctor will also need to confirm your diagnosis with an MRI or CT scan report.

There are several reasons you might not be able to join. For example, if you've had back surgery in the last year, have certain brain or nerve problems, or other serious health conditions that would make exercise unsafe, this study isn't for you. You also need to be willing and able to use an exercise bike at home. This study is taking place in areas where French is spoken, so you would need to be able to understand and read French.

If you already own an exercise bike or currently have a legal guardian (like someone with power of attorney over your financial and medical decisions), you wouldn't be able to participate either. The research team needs to make sure everyone in the study starts from a similar point regarding access to cycling equipment and their health situation.

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 50 years old or older?
Has a doctor told you that you have lumbar spinal stenosis?
Do you get back or leg pain when walking that gets better when you sit?
Are you able and willing to use an exercise bike at home?
Have you *not* had back surgery in the last 12 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two groups by chance. One group will continue with their usual care (which could be anything your doctor normally recommends) and also receive a special exercise bike to use at home. The other group will only receive their usual care.

No matter which group you're in, the researchers will check in with you and assess your back pain and how easily you can do daily tasks at the beginning of the study, and then again after 4 months. The home cycling program would involve regular use of the provided ergometric bicycle. The total duration of the main assessment period for the study is 4 months.

Potential risks and benefits

Taking part in this study could potentially help you understand if a home cycling program might improve your back pain and ability to do daily activities. However, it's also possible that you won't experience any benefit, or that home cycling might not be suitable for you. As with any exercise, there's always a small risk of muscle soreness or mild discomfort, but the researchers will ensure you are medically fit for exercise. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What is Lumbar Spinal Stenosis?

It's a condition where the spaces in your lower spine narrow, putting pressure on nerves, which often causes back and leg pain when standing or walking, but feels better when sitting.

What is 'usual care'?

Usual care means the kind of treatment or advice your doctor would normally give you for your condition, which could include things like medication, physical therapy, or other recommendations.

Will I have to pay for the exercise bike?

No, if you are assigned to the cycling group, a special exercise bike will be provided for your use at home for the duration of the study.

How long will the study last for me?

The main part of the study where your progress is being closely monitored will last for 4 months.

What if I don't speak French?

Unfortunately, if you are unable to speak or read French, you wouldn't be able to participate in this particular study.

How to find out more

Christelle Nguyen, MD, PhD

christelle.nguyen2@aphp.fr +33 1 58 41 25 35 Official trial record

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