A trial looking at exercise to help recovery after bowel cancer surgery (PREPARE ABC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Status:

Closed

Phase:

Other

This trial is for people who are going to have an operation to remove their bowel cancer.

More about this trial

Surgery is one of the main treatments used for bowel (colorectal) cancer. Having an operation to remove part of the bowel is physically demanding.

Runners have to train to help their bodies cope with the demands of races. In the same way, doctors think that taking part in an exercise programme might help to train your body to cope with the demands of an operation.

Some people in this trial will take part in an exercise programme before surgery and for about a year after their operation. This might take place in hospital, or at home. Other people in this trial will have routine care and do not take part in an exercise programme.

The trial team will compare the different groups and collect information about:

length of hospital stay
any problems after surgery
motivation and levels of physical activity
physical and psychological well being

The aims of this trial are to:

see if exercise training can improve your recovery after surgery
find out whether exercise before surgery can improve fitness
find out whether an exercise programme at home or in hospital is better than usual care

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply. You

Are due to have bowel (colorectal) surgery with the aim of curing your disease
Are fit and well enough to have surgery
Are able to understand written and spoken instructions in English
Are at least 18 years old

You cannot join this trial if any of these apply. You

Are unable to do the exercise, or it is not safe for you to exercise in this trial. For example, you have joint or muscle problems, a chronic lung disease that causes symptoms such a breathlessness at rest, or a lower limb amputation without a prosthesis
Have a severe mental health problem that the trial team think could affect you taking part
Have any heart conditions that would prevent you from safely doing the exercise in this trial. For example, you have angina or high blood pressure that is not controlled with medication, or you have had a heart attack in the last 6 weeks
Are taking part in another trial (you may still be able to take part if the 2 trial teams agree that this is OK)

Trial design

The researchers need 1146 people to join.

It is a randomised trial. The people taking part are put into 3 different groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

One group takes part in a hospital based exercise programme
One group takes part in a home based exercise programme
One group has routine care (this is the control group)

Prepare ABC trial diagram

Hospital based exercise group
You have an exercise counselling session before you start your exercise programme. This takes about 45 minutes and is at hospital.

During this session, the research physiotherapist will explain what the hospital supervised sessions involve. They will discuss with you how you can become more physically active after your operation. This includes who can help and support you in becoming more active. For example, friends and family and services in your local area.

You then go to hospital for your training sessions with one of the research physiotherapists. You go up to 3 times a week in each of the 4 weeks leading up to your operation. It doesn’t matter if you can’t make all the appointments. But try to go to as many as possible.

About 6 weeks after your operation, you restart your hospital exercise sessions. You have these every month for about 1 year.

Your level of fitness is assessed at the first visit. Your exercise programme is then planned, depending on the results of your assessment. Hospital exercise sessions will take about an hour and will involve exercising on a stationary exercise bike.

You are also asked to do some resistance exercises at home, twice a week. For example, you pull on an elasticated resistance band. This band is provided by the physiotherapist and helps to build up your muscle strength.

Home based supported exercise group
You have an exercise counselling session before you start your exercise programme. This takes about 45 minutes and is at hospital.

During this appointment the research physiotherapist will discuss with you how you can become more physically active after your operation. This includes who can help and support you in becoming more active. For example, friends and family and services in your local area.

The aim of the programme is to help you achieve 150 minutes of moderate intensity exercise each week. This might include brisk walking, jogging, cycling or swimming.

You are also asked to do some resistance exercises twice a week. For example, you pull on an elasticated resistance band. This band is provided by the physiotherapist and helps to build up your muscle strength.

You have a telephone call from a researcher or physiotherapist once a week before your operation. This can be a pre arranged time that suits you. They ask how you are doing, encourage you to stay active and answer any questions you might have.

About 6 weeks after your operation, you are encouraged to restart your exercise. You have a monthly telephone call with a researcher or physiotherapist for about 1 year.

Standard care
You do not take part in an exercise programme. But you have the same tests and fill out the same questionnaires as the 2 other groups (see hospital visits below).

Hospital visits

Everyone has an exercise test on two separate occasions before their operation. This takes place at hospital and measures your fitness. This is called a cardiopulmonary exercise test (CPET). It looks at how well your lungs, heart and muscles work during exercise.

Everyone is asked to fill in some questionnaires on 5 different occasions during the 12 months of the trial. The questionnaires ask you about:

general well being
any visits to your GP or the hospital
the exercise you do

The questionnaires take about 35 minutes to complete, either at home or in hospital.

Your grip strength will also be measured. The researchers use a machine to measure your grip strength on 3 different occasions over the course of the year.

Side effects

Your exercise programme (if you have one) is planned to suit your level of fitness. You are supervised by a physiotherapist as part of the hospital based programme. Or you are supported through telephone contact if you do the home based programme.

The risk of the exercise programmes is thought to be low and no more risky than usual exercise.