A trial looking at a planned exercise programme after surgery for non small cell lung cancer - RAPS

Please note this trial is no longer recruiting patients.

This trial is to see if a planned exercise programme after surgery for non small cell lung cancer can help people recover better.

If you have non small cell lung cancer, you may have surgery to remove it with the aim of curing the cancer. But after surgery people often have pain, tiredness and shortness of breath. It takes some time to feel better and get back to your normal level of activity. Doctors call this rehabilitation.

The researchers think that having a planned programme of regular exercise that gradually increases may help people rehabilitate more quickly.

The aim of this trial is to find out if an exercise programme started in hospital, and continued with support at home, can help increase the levels of people’s activity 4 weeks after surgery.

Recruitment

Start 01/10/2010

End 30/12/2011

Phase

Other

Who can enter

You may be able to enter this trial if you

Have non small cell lung cancer
Are having surgery to remove part of one of your lungs (lobectomy) or the whole lung (pneumonectomy) with the aim of curing your cancer

You cannot enter this trial if you were in the intensive care unit for more than 48 hours after surgery to remove your cancer.

Trial design

This trial will recruit up to 120 people. It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in.

Everyone will have an Actiwatch activity monitor that you wear on your wrist like a wristwatch. It records your activity and you can use it as a watch. You wear this for at least 72 hours before you go in to hospital. You continue to wear it in hospital until discharge. You will also wear it for at least 72 hours during the 4 weeks after your discharge from hospital. You can wear the activity monitor all the time. It is waterproof for up to 20 minutes.

People in group1 will have standard care after surgery. The physiotherapist will see you on the 1st, 2nd and 3rd days after surgery. They will get you to walk, step on the spot or do some easy cycling on an exercise bike. They will help you to continue with regular activity and walking around while you are in hospital.

Before you go home, the physiotherapist will give you general advice about how to stay active. When you are at home, they will call you each week to encourage you and see how you are.

People in group 2 will have the same standard care. In addition you will cycle for up to 30 minutes on an exercise bike. For the first 2 minutes you warm up with some easy cycling. After that the physiotherapist will increase the difficulty. You can stop before the 30 minutes if you start to feel out of breath or tired.

Before you go home the physiotherapist will give you a home exercise programme. You take home a small device that records how many steps you walk each day. When you are at home, the physiotherapist will call you twice a week to record your average daily step count. They will encourage you to increase the number of steps you take each day.

Everyone will have a weekly diary card to record what exercise they do. You return the diary to the research team at the end of the trial.

If you agree to take part in the trial the researchers will ask you to fill in 2 questionnaires, before surgery and 4 weeks after leaving hospital. They will ask you about how you are and any side effects you have. These are called quality of life questionnaires.

Hospital visits

You see the physiotherapist or a member of the research team before surgery, and then about 5 days and 4 weeks after you go home from hospital. They will measure your

Height and weight
Thigh muscle strength – this is done by asking you to squeeze your legs together against resistance
Exercise tolerance by using a simple walking test