Not yet recruitingNAINTERVENTIONAL

Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery

This research wants to see if a special preparation programme, called 'prehabilitation', can help people recover better after shoulder surgery for a torn rotator cuff. This programme involves exercises you do at home, information about your condition, and advice on managing pain, all before your operation. We are comparing this to the usual care provided. Adults who are planning to have surgery for a rotator cuff tear can take part. Researchers will check things like how well your shoulder works and how you feel about your recovery over two years after surgery. The aim is to find out if prehabilitation improves surgical outcomes and patient satisfaction.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Prof. Arasch Wafaisade

Enrolment target

Start

18 Mar 2025

Estimated completion

01 Feb 2029

Rotator Cuff

What is this study about?

Imagine you're getting ready for a big run, and you do some training beforehand – that's a bit like what 'prehabilitation' is for surgery. This study is looking at whether getting prepared for shoulder surgery can help you recover better and feel happier with the results. It focuses on adults in the UK who are having an operation because they've torn a muscle in their shoulder, known as a rotator cuff.

Researchers want to see if a special programme before surgery makes a difference. This programme includes doing exercises at home, learning about your shoulder condition and how to manage pain, and getting advice on things you can do to help yourself. Some people in the study will do this special programme, while others will receive the usual information given before surgery. By comparing these two groups, doctors hope to learn if this preparation can lead to a quicker and more satisfying recovery.

The main thing doctors will measure is how well your shoulder works and how you feel about it both before and after the surgery, over a period of two years. This helps them understand whether getting ready for surgery like this could become a standard part of care for people having shoulder operations in the future.

Key takeaways

This study evaluates preparing for shoulder surgery to improve recovery.
It's for adults planning surgery for a torn rotator cuff.
It compares a 'prehabilitation' programme to standard care.
The programme includes exercises and information before surgery.
Recovery and satisfaction will be tracked for up to 2 years.
Voluntary participation, with the right to withdraw at any time.

Who may be eligible?

To be part of this study, you need to be an adult who has been told by a doctor that you have a torn rotator cuff in your shoulder and that surgery is planned to fix it. This tear could have happened from an injury or developed over time.

There are certain reasons why you might not be able to join the study. For example, if you've recently broken a bone in your arm or shoulder, or if you have conditions like rheumatoid arthritis (which causes joint inflammation) or fibromyalgia (a condition causing widespread body pain). You also can't take part if you have other shoulder problems like a 'frozen shoulder' or if your shoulder keeps dislocating. People with nerve problems, or those who have difficulty understanding or speaking, would also not be able to join.

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 an adult aged 18 or over?
Have you been diagnosed with a torn rotator cuff that needs surgery?
Do you currently have any other arm/shoulder fractures, inflammatory arthritis, or neurological conditions?
Do you feel able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be put into one of two groups by chance – like flipping a coin. One group will get the usual information about their hospital stay. The other group will do a special prehabilitation programme for about six weeks before their surgery. This programme includes information about your condition and pain relief, advice on things you can do to help yourself, and exercises you can do at home.

No matter which group you're in, you'll have your shoulder assessed several times. These assessments happen when you join the study, just before your surgery, and then again after your surgery at 6 months, 12 months, and 24 months. These assessments involve checking how well your shoulder is working and asking you questions about how you feel. The total duration of your participation, including follow-up, will be around two years after your surgery.

Potential risks and benefits

Taking part in this study may offer benefits, such as potentially improving your recovery after shoulder surgery if you are in the prehabilitation group. Even if you are in the control group, your progress will be carefully monitored, which can be reassuring. The main 'risk' is the time commitment for the follow-up assessments. While there are no direct medical risks from the study interventions mentioned, participating in any research involves sharing personal information, which will be kept confidential. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Kliniken der Stadt Köln gGmbH
Verified postcode
Cologne, Germany

Common questions

What is a rotator cuff tear?

It's when one or more of the tendons (strong cords of tissue) in your shoulder, which help you lift and rotate your arm, are torn. This often causes pain and weakness.

What does 'prehabilitation' mean?

It means preparing your body and mind for surgery with exercises, information, and advice, helping you get ready before the operation.

How long will the study last if I join?

Your participation would involve assessments over a period of about two years after your surgery.

Will I know which group I'm in?

Yes, if you're in the prehabilitation group, you'll be given the exercises and information. If you're in the control group, you'll receive standard hospital information.

Does this study involve new medications?

No, this study focuses on a pre-surgery preparation programme and does not involve any new medications.

How to find out more

Arasch Wafaisade, Prof. Dr. med.

wafaisadea@kliniken-koeln.de +49-221-8907-18600 Official trial record

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