The feasibility of performing a walking programme in patients with rectal cancer undergoing chemo-radiotherapy (the REx trial)

ISRCTN	ISRCTN62859294
DOI	https://doi.org/10.1186/ISRCTN62859294
Secondary identifying numbers	The REx Trial GN130N328

Submission date: 21/01/2014
Registration date: 17/03/2014
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-walking-programme-chemoradiotherapy-rectal-cancer-rex

Contact information

Miss Susan Moug
Scientific

Level 5, Surgical Block
Royal Alexandra Hospital
Corsebar Road
Paisley
PA2 9PN
United Kingdom

Phone	+44 (0)141 314 6965
Email	susanmoug@nhs.net

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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(s)	West of Scotland Research Ethics Service (WoSRES), 22/04/2014, ref: 14/WS/0079
Condition	Rectal cancer
Intervention	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	Other
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 study start date	01/06/2014
Overall study end date	01/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
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 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 patients 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	01/06/2014
Recruitment end date	01/06/2016

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Royal Alexandra Hospital

Paisley
PA2 9PN
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

c/o Nathaniel Brittain
Academic Research Co-ordinator
Research and Development Central Office
Tennent Institute
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Phone	+44 (0)141 211 8544
Email	nathaniel.brittain@ggc.scot.nhs.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Chief Scientist Office (UK), ref.: CZH/4/984
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	feasibility results	01/05/2019	21/01/2019	Yes	No
Plain English results			20/02/2020	No	Yes
Results article	muscle mass results	01/09/2020	22/06/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

25/10/2022: Internal review.
22/06/2020: Publication reference added.
20/02/2020: Added link to basic results (scientific field)
21/01/2019: Publication reference added.