Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Miss Susan Moug


Contact details

Level 5
Surgical Block
Royal Alexandra Hospital
Corsebar Road
United Kingdom
+44 (0)141 314 6965

Additional identifiers

EudraCT number number

Protocol/serial number

The REx Trial GN130N328

Study information

Scientific title

A pilot study of the feasibility and patient-related outcomes of performing a walking intervention in patients undergoing treatment for rectal cancer (the REx trial)


Study hypothesis

It is hypothesised that improving exercise capacity pre-operatively (pre-habilitation) by performing an individualised walking intervention will be feasible and lead to improvement in peri-operative psychological and physical health.

Ethics approval

West of Scotland Research Ethics Service (WoSRES), 22/04/2014, ref: 14/WS/0079

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Rectal cancer


The patients randomized to the walking group will have a consultation with the Project Co-ordinator (PC) where the walking intervention, including the use of the pedometer, will be explained with stepping count targets described. Pedometers have been used successfully by this research team and have been shown to be a motivational tool, which will increase walking in the short term and sustain walking over 12 months. The walking programme will consist of 15-17 weeks of intervention with the first 6 weeks consisting of graduated bi-weekly goals.
The aim will be that walking behaviour is either maintained over the remaining weeks or increased according to the individual. The goal is for the participants to increase their average daily step count by 3000 accumulated above their baseline value: based on the assumption that an adult walking at a moderate pace produces 100 steps/minute, an increase of 3000 steps on 5 days of the week would correspond to approximately 150 minutes of moderate physical activity over the course of the week, which is the recommended physical activity level for older adults in Scotland.

Control group: No walking intervention

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. To assess the feasibility of performing a walking intervention in patients with rectal cancer undergoing pre-operative chemo-radiotherapy.
2. How many patients can be recruited per month on average and what proportion of eligible patients are willing to be recruited?
3. Are patients willing to be randomised?
4. What is the initial retention and adherence levels that can be achieved for the programme in both interventional and control groups?
5. How many patients drop out of such a study and for what reasons?
6. Are patients able to carry out the intervention as planned and can it be successfully implemented?
7. How acceptable are the intervention, the delivery of, the duration of, the intensity of and the exit strategy to the participants?
8. What are the indicative cost implications of intervention delivery?

To assess primary and secondary outcomes, Tests 1 and 2 will be performed at two time points: pre-chemo-radiotherapy and post-chemo-radiotherapy/pre-surgery (referred to as Test 1 and Test 2, respectively). These tests include: feasibility measurements; body mass index, hip and waist circumference; sit-to-stand test, 6-minute walking test; sedentary time, active time, average steps walked per day. Psychological and quality of life will also be assessed at Tests 1 and 2 by: Becks Depression Inventory (BDI-II), FACT-C, PANAS, EORTC-QLQ C30. Peri-operative outcomes will be recorded during the patient's in-hospital stay post-surgery and for up to 30 days after surgery (length of hospital stay, length of level 2 stay, complications, time to medical discharge, mortality).

Secondary outcome measures

1. Does pre-habilitation increase the number of steps walked per day?
2. Does pre-habilitation lead to improved recovery after surgery (in terms of time to step down
from critical care; incidence of morbidity and time to discharge from hospital)?
3. Does pre-habilitation increase the average time spent per day in physical activity?
4. Does pre-habilitation decrease the average time spent per day in sedentary behaviour?
5. Does pre-habilitation lead to reduced fatigue and improved psychological and quality of life parameters?

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Any patient over 18 years of age
2. Independently mobile
3. Has been diagnosed with rectal cancer
4. Planned first line of treatment is chemotherapy and radiotherapy followed by curative surgery
(timing at discretion of surgeon, but expected between 10-12 weeks post-CRX)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Chemotherapy and radiotherapy not first-line treatment
2. Patient has had previous malignancies
3. Significant co-morbidity where inclusion into this trial would put the patient’s health at risk
4. Patient has any mental, physical or psychological impairment that prevents them from giving signed informed consent
5. Patient is already achieving their recommended activity level per week where participation in a walking programme would mean he/she would be exercising at a lower level than normal

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal Alexandra Hospital
United Kingdom

Sponsor information


NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Nathaniel Brittain
Academic Research Co-ordinator
Research and Development Central Office
Tennent Institute
38 Church Street
G11 6NT
United Kingdom
+44 (0)141 211 8544

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Chief Scientist Office (UK), ref.: CZH/4/984

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Local government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

See (added 20/02/2020)

Publication list

2019 feasibility results in (added 21/01/2019)
2020 muscle mass results in (added 22/06/2020)

Publication citations

Additional files

Editorial Notes

22/06/2020: Publication reference added. 20/02/2020: Added link to basic results (scientific field) 21/01/2019: Publication reference added.