RecruitingNAINTERVENTIONAL

Trial of an Exercise Intervention for Children With Haemophilia

Haemophilia can lead to weak muscles and painful joints, making it hard for boys to play with friends. This study explores if a new 12-week exercise programme, designed with input from boys with haemophilia, their parents, and physiotherapists, can help improve muscle strength and overall well-being. We know exercise is good for us, but for children with haemophilia, there's not much clear evidence about strengthening exercises. Researchers want to find out if this programme can reduce pain and improve joint movement without causing any harm. Boys aged 6-12 will be randomly put into two groups: one doing the exercise programme and one continuing with their usual care, to compare the results safely and fairly.

At a glance

Status

Recruiting

Phase

Sponsor

East Kent Hospitals University NHS Foundation Trust

Enrolment target

132

Start

06 May 2021

Estimated completion

30 Jun 2025

Hemophilia Child, Only Musculoskeletal Diseases or Conditions

What is this study about?

This study is looking into how exercise might help young boys with a condition called haemophilia. Haemophilia means that a person's blood doesn't clot properly, which can lead to bleeding into their muscles and joints. This often results in weak muscles and painful, stiff joints, making it difficult for children to move around and play. We understand that being able to join in with games and friends is really important for boys with haemophilia, and this study aims to see if an exercise programme can make that easier.

Currently, we don't have a lot of clear information about whether specific muscle-strengthening exercises are good or bad for young children with haemophilia. Because of this, researchers, working closely with boys who have haemophilia, their parents, and physiotherapists, have put together a special exercise plan. They believe this plan could help strengthen muscles, reduce pain, improve how well their joints move, and ultimately help them participate more fully in everyday activities and improve their long-term health.

To find out if this exercise programme works, the researchers are inviting boys with haemophilia aged 6 to 12 years old to take part. Some boys will be asked to follow the 12-week exercise programme specifically designed for hip, knee, and ankle muscles, while others will continue with their usual care. By comparing these two groups, the researchers hope to understand if the exercise programme makes a real difference to the boys' health and well-being. They've already done some early checks and found the exercises were safe and acceptable to the children.

Key takeaways

This study investigates if a new exercise programme can help boys with haemophilia.
The programme is designed to strengthen muscles and potentially improve joint health.
Boys aged 6-12 with moderate or severe haemophilia A or B may be eligible.
Participants will be randomly assigned to either an exercise group or a usual care group.
The study lasts 12 weeks with various assessments to track progress.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, a boy must be between 6 and 12 years old and have a moderate or severe form of haemophilia A or B. This ensures the study focuses on the specific group for whom the exercise programme is designed.

However, some conditions would mean a boy couldn't join. For example, if he has a different bleeding disorder called von Willebrand disease, or if he's had a fracture, trauma, or surgery on his legs in the past. Boys who have had a recent bleed in their leg joint or muscle (within the last 6 weeks), or those experiencing lower leg pain that might affect their ability to exercise, would also not be able to participate.

Additionally, boys with certain brain injuries or conditions affecting their central nervous system, or those who might struggle to understand and follow instructions, couldn't take part. This helps ensure that the boys in the study can safely and fully engage with the exercise programme.

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.

Is your child a boy aged between 6 and 12 years old?
Does your child have moderate or severe haemophilia Type A or B?
Has your child NOT had any recent leg injuries, surgery, or joint bleeds in the last 6 weeks?
Is your child currently free from lower leg pain and able to follow instructions?
Does your child NOT have von Willebrand disease or certain brain conditions?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will be randomly assigned to one of two groups. One group will follow a special 12-week exercise programme designed to strengthen leg muscles. The other group will continue with their usual care, without additional exercises from the study. The aim is to compare results between these two groups.

Over the course of the study, there will be various assessments to monitor their progress. These might include checking their muscle strength, how well their joints move, and asking about any pain they might have. The researchers will also want to understand if the exercises help them participate more in activities they enjoy. We anticipate regular check-ins and assessments throughout the 12-week period. The total duration of active participation in the study, including assessments, will be around 12 weeks, with potential for some follow-up observations after that.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefits of this study include the possibility that the exercise programme could improve muscle strength, reduce pain, enhance joint movement, and allow your child to participate more fully in activities. However, it's also possible that the exercises might not have any effect or, in rare cases, could potentially cause discomfort or, very rarely, lead to a bleed if not done correctly. The exercises have been carefully designed and checked for safety. Your child's well-being is paramount, and you are free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Haemophilia Centre
Verified postcode
Canterbury, United Kingdom· Recruiting

Common questions

What is haemophilia?

Haemophilia is a condition where the blood doesn't clot properly, which can lead to bleeding into muscles and joints, causing pain and difficulty moving.

Why is exercise being studied for haemophilia?

Exercise is known to be good for muscles and joints, but we need more clear information to know if specific strengthening exercises are safe and helpful for children with haemophilia to improve their long-term health.

What will my child do in the exercise programme?

If selected for the exercise group, your child will follow a 12-week programme designed to strengthen hip, knee, and ankle muscles. These exercises were created with help from children with haemophilia, their parents, and experts.

Will my child definitely do the exercises?

No. Your child will be randomly assigned to either the exercise group or a group that continues with their usual care. This helps ensure fair comparison.

What if we change our mind about participating?

You are free to withdraw your child from the study at any point, and this decision will not affect your child's medical care in any way.

How to find out more

David Stephensen, PhD

david.stephensen@nhs.net 01227783166 Official trial record

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