Active not recruitingNAINTERVENTIONAL

Home-based Exercise in Renal Transplant Recipients

This study is investigating if a personalised exercise program, done at home, can improve heart health in people who have received a kidney transplant. Even though a transplant significantly improves health compared to dialysis, heart problems are still the main cause of death for these patients. This is often due to conditions like high blood pressure and diabetes, and the medicines transplant patients need to take. Exercise is known to help with heart disease, and this study will look at its effects on the heart and blood vessels using detailed scans. Half the participants will follow the exercise program for 12 weeks, while the other half will continue their usual care. Researchers will also check physical fitness, body changes, and how people feel about their quality of life.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Leicester

Enrolment target

Start

30 Jan 2020

Estimated completion

30 Jun 2027

Kidney Transplant; Complications

What is this study about?

If you've had a kidney transplant, your health has likely improved a lot compared to being on dialysis. However, even with a successful transplant, heart problems remain the most common cause of death for people like you. This might seem surprising, but it's often linked to conditions that are more common in people with kidney transplants, such as high blood pressure and diabetes. The medicines you need to take to stop your body from rejecting the new kidney can also play a role.

We know that exercise is generally very good for heart health. It can help manage many of the risk factors that contribute to heart disease, not just in the general population, but also in people who have had a kidney transplant. Because of this, researchers want to find out if a special exercise program, designed for individuals and done at home, can help improve the health of the heart and blood vessels in kidney transplant recipients.

This study will involve two groups of people. Half will take part in a 12-week home-based exercise program, while the other half will continue with their usual medical care. To understand the effects of exercise, researchers will use detailed MRI scans to look at participants' hearts and blood vessels both at the beginning and end of the study. They will also measure things like your physical fitness, how well you can exercise, certain markers in your blood related to heart health, changes in your body shape, and how your overall quality of life might improve.

Key takeaways

This study investigates home-based exercise for kidney transplant patients.
It aims to improve heart health, a key concern after transplant.
Detailed heart scans (MRI) will measure changes.
Half of participants will do a 12-week home exercise program.
You must be an adult with a kidney transplant and certain heart risk factors.
Participation involves assessments, potentially exercise, and questionnaires.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 or over and have had a kidney transplant at least one year ago. You also need to be willing to give your informed consent, which means understanding what the study involves and agreeing to participate.

Additionally, you should have at least one of the following risk factors that can affect heart health: diabetes, high cholesterol, high blood pressure, a history of heart attack or stroke, or obesity (a BMI over 30).

There are also some reasons why you might not be able to join. These include if you can't exercise due to physical or mental health reasons, if you can't have an MRI scan, or if your doctor advises against exercise for you. If you are pregnant, breastfeeding, or planning to become pregnant during the study, you also wouldn't be able to participate. Lastly, if you have other serious health problems that could make taking part risky or affect the study results, you won't be eligible.

Quick self-check

Are you 18 years old or older?
Did you have your kidney transplant over a year ago?
Do you have diabetes, high blood pressure, high cholesterol, a history of heart/stroke, or obesity?
Can you safely do exercise?
Can you have an MRI scan?
Are you not pregnant or planning pregnancy during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first be assessed to see which group you'll be in (either the home exercise group or the usual care group). If you're in the exercise group, you'll follow a personalised exercise program at home for 12 weeks. Both groups will have detailed MRI scans of their heart and blood vessels at the beginning and again at the end of the 12-week period. Researchers will also measure your physical fitness, how well you can exercise, and take blood samples to check for markers of heart health. You'll also be asked to complete questionnaires about your quality of life. The total duration of active participation in the study, including assessments, will be approximately 12 weeks, with follow-up appointments depending on the study's specific schedule.

Potential risks and benefits

Taking part in this study could offer several potential benefits, especially if you are in the exercise group. These might include improvements in your heart health, physical fitness, and overall well-being. However, as with any exercise program, there's always a small risk of muscle soreness, minor injury, or that your health might not improve as expected. The MRI scans involve exposure to strong magnetic fields and a contrasting agent, which carries minimal risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Leicester NHS Trust
Leicester, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to see if a home exercise program can improve heart health in people who have had a kidney transplant.

How long does the study last?

The exercise program lasts for 12 weeks, and the full study participation, including all assessments, will be around that time frame.

Will I have to pay to participate?

No, you will not have to pay to participate in the study. All study-related assessments and interventions are free.

What are MRI scans for?

MRI scans are used to get detailed pictures of your heart and blood vessels to see if there are any changes as a result of the exercise program.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without giving a reason, and it will not affect your medical care.