Supportive exercise programmes for accelerating recovery after major abdominal cancer surgery
| ISRCTN | ISRCTN82233115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82233115 |
| Secondary identifying numbers | 30965 |
- Submission date
- 07/07/2016
- Registration date
- 07/07/2016
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Ms Beauty Mutandari
Public
Public
Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603 591263 |
|---|---|
| B.Mutandari@uea.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural, Physical |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | SupPoRtive Exercise Programmes for Accelerating REcovery after major ABdominal Cancer surgery (PREPARE-ABC) – A multicentre, 3 arm, parallel randomised controlled trial of standard care alone versus standard care plus supervised hospital based exercise and standard care plus supported home-based exercise pre and post hospital discharge in cancer patients awaiting curative colorectal cancer surgery |
| Study acronym | PREPARE-ABC |
| Study hypothesis | The aim of this study is to investigate whether an exercise intervention would be beneficial to patients pre and post hospital discharge when undergoing curative colorectal surgery. |
| Ethics approval(s) | 22/06/2016, ref: 16/EE/0190 |
| Condition | Colorectal cancer |
| Intervention | Current interventions as of 19/08/2019: Control arm: Treatment as Usual (TAU) comprising the patient information leaflet and study follow-up visits only. No other information relating to peri-operative exercise will be offered outside of what constitutes current standard practice for each recruiting centre. Intervention arm A (hospital-based supervised exercise): Pre-surgery, participants receive an initial 45 min exercise counselling incorporating behaviour modification techniques. Patients will be offered up to three sessions per week of aerobic interval exercise on a cycle ergometer prior to their procedure. Patients are encouraged to attend as many pre-operative supervised exercise sessions as possible. In addition, patients will undertake twice-weekly resistance exercise. Exercise programmes will be tailored to each patient, taking the previous level of activity, mobility and any barriers to exercise into consideration. Until the end of the study (12 months post-randomisation), patients will be encouraged to comply with current physical activity recommendations: 150 min of moderate-intensity aerobic exercise per week (brisk walking/cycling) and two sessions of resistance exercise per week. They will also be signposted to local exercise facilities and receive monthly supervised exercise sessions. Intervention arm B (supported home-based exercise): Participants receive an initial 45 min exercise counselling incorporating behaviour modification techniques. Patients will then be encouraged to comply with current physical activity recommendations, which will form the basis of the home exercise programme: a minimum of 150 min of moderate-intensity aerobic exercise per week (brisk walking/cycling) and two sessions of resistance exercise. Exercise programmes will be tailored to each patient, taking the previous level of activity, mobility and any barriers to exercise into consideration. Patients will receive weekly 15 min telephone support from a Trial Physiotherapist to encourage compliance with the exercise programme. Until the end of the study (12 months post-randomisation), patients will be encouraged to comply with current physical activity recommendations and sign posted to local exercise facilities and receive monthly 15 min motivational telephone calls from a Trial Physiotherapist. Previous interventions: Participants are randomly allocated to one of three groups. Control arm: Treatment as Usual (TAU) comprising the patient information leaflet only. No other information relating to peri-operative exercise will be offered, consistent with current practice. Intervention arm 1 (Hospital-Based Supervised exercise programme): Pre-surgery, participants receive an initial 45 min exercise counselling incorporating behaviour modification techniques. Patients will be offered three sessions per week of aerobic interval exercise on a cycle ergometer over 3-4 weeks prior to their procedure (aim is to achieve 12 sessions). In addition, patients will undertake twice-weekly resistance exercise. Exercise programmes will be tailored to each patient, taking the previous level of activity, mobility and any barriers to exercise into consideration. Until the end of the study (12 months post-randomisation), patients will be encouraged to comply with current physical activity recommendations: 150 min of moderate-intensity aerobic exercise per week (brisk walking/cycling) and two sessions of resistance exercise per week. They will also be signposted to local exercise facilities and receive monthly supervised ‘booster’ exercise sessions. Intervention arm 2 (Supported Home-Based exercise): Participants receive an initial 45 min exercise counselling incorporating behaviour modification techniques. Patients will then be encouraged to comply with current physical activity recommendations, which will form the basis of the home exercise programme: a minimum of 150 min of moderate-intensity aerobic exercise per week (brisk walking/cycling) and two sessions of resistance exercise. Exercise programmes will be tailored to each patient, taking the previous level of activity, mobility and any barriers to exercise into consideration. Patients will receive weekly 15 min telephone support from a Trial Physiotherapist to encourage compliance with the exercise programme. Until the end of the study (12 months post-randomisation), patients will be encouraged to comply with current physical activity recommendations and signposted to local exercise facilities and receive monthly 15 min motivational telephone calls from a Trial Physiotherapist. |
| Intervention type | Behavioural |
| Primary outcome measure | Health-related quality of life is measured using the Study Short-Form Health Questionnaire (SF-36) at baseline and 12 months post-randomisation. |
| Secondary outcome measures | 1. Post-operative morbidity is measured 30 days post-surgery 2. Cardiopulmonary fitness 3. Grip strength 4. Length of hospital stay is recorded at discharge following operation 5. Fitness for discharge is recorded at discharge following operation 6. Re-admission rate is determined 90 days post-surgery 7. Post-operative mortality is measured 90 days post-surgery 8. Physical activity behaviour is measured 6 and 12 months 9. Psychological health status is measured 6 and 12 months |
| Overall study start date | 01/11/2016 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1146; UK Sample Size: 1146 |
| Participant inclusion criteria | 1. Male and female participants ≥ 18 years old 2. Awaiting a curative elective colorectal resection for cancer 3. American Society of Anaesthesiologists physical status I-III (ASA, 2014) 4. Able and willing to provide informed consent 5. Understand verbal and written instructions in English 6. Patients who are already participating (or have participated) in other trials may be eligible, but this must be agreed in advance by the relevant trial teams |
| Participant exclusion criteria | 1. Contra-indications to exercise (e.g. lower limb amputation without prosthesis, orthopaedic disorder exacerbated by exercise, chronic lung disease causing desaturation with exercise or shortness of breath at rest, severe psychiatric health problems) 2. Cardiovascular contraindications (e.g. unstable angina, acute left ventricular failure, uncontrolled cardiac arrhythmias, uncontrolled hypertension, cardiac event in the previous 6 weeks, cerebral vascular disease resulting in transient ischaemic attacks) 3. Participation in other treatment trials, where this has not been agreed in advance with both trial teams |
| Recruitment start date | 01/11/2016 |
| Recruitment end date | 31/10/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham
B15 2WG
United Kingdom
B15 2WG
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby
DE22 3DT
United Kingdom
DE22 3DT
United Kingdom
Imperial College Healthcare NHS Trust
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Northumbria Healthcare NHS Trust
North Shields
NE29 8NH
United Kingdom
NE29 8NH
United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
North West Anglia NHS Foundation Trust
Peterborough
PE3 9GZ
United Kingdom
PE3 9GZ
United Kingdom
Western General Hospital
NHS Lothian
Edinburgh
EH4 2XU
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Manchester Royal Infirmary
Manchester University NHS Foundation Trust
Manchester
M13 9WL
United Kingdom
Manchester
M13 9WL
United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay
TQ2 7AA
United Kingdom
TQ2 7AA
United Kingdom
Harrogate and District NHS Foundation Trust
Harrogate
HG2 7SX
United Kingdom
HG2 7SX
United Kingdom
Glasgow Royal Infirmary
NHS Greater Glasgow and Clyde
Glasgow
G4 0SF
United Kingdom
Glasgow
G4 0SF
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
South Tyneside District Hospital
South Tyneside and Sunderland NHS Foundation Trust
South Shields
NE34 0PL
United Kingdom
South Shields
NE34 0PL
United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
IP33 2QZ
United Kingdom
Ipswich Hospital
East Suffolk and North Essex NHS Foundation Trust
Ipswich
IP4 5PD
United Kingdom
Ipswich
IP4 5PD
United Kingdom
St Mark’s Hospital
London North West University Healthcare NHS Trust
London
HA1 3UJ
United Kingdom
London
HA1 3UJ
United Kingdom
Royal Free London NHS Foundation Trust
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Raigmore Hospital
NHS Highland
Inverness
IV2 3UJ
United Kingdom
Inverness
IV2 3UJ
United Kingdom
University Hospital Crosshouse
NHS Ayrshire and Arran
Kilmarnock
KA2 0BE
United Kingdom
Kilmarnock
KA2 0BE
United Kingdom
Furness General Hospital
University Hospitals of Morecambe Bay NHS Trust
Lancaster
LA14 4LF
United Kingdom
Lancaster
LA14 4LF
United Kingdom
Sponsor information
Norfolk and Norwich University Hospitals NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Colney Lane
Norwich
NR4 7UY
England
United Kingdom
"ROR" |
https://ror.org/01wspv808 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/10/2021 | 01/11/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/12/2023: Study contact updated.
04/07/2022: The following changes were made to the trial record:
1. Contact details updated.
2. The recruitment end date was changed from 31/10/2022 to 31/10/2022.
3. The overall trial end date was changed from 30/06/2021 to 30/04/2024.
4. The intention to publish date was changed from 30/06/2022 to 30/04/2025.
01/11/2021: Publication reference added.
03/06/2021: Recruitment for this study is no longer paused and the recruitment end date has been changed from 30/06/2021 to 31/10/2022.
09/09/2020: The following changes have been made:
1. The publication and dissemination plans has been added.
2. The IPD sharing statement has been added.
02/06/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2020 to 30/06/2021.
2. The overall end date was changed from 01/05/2020 to 30/06/2021.
3. The intention to publish date was changed from 01/05/2021 to 30/06/2022.
04/05/2020: Due to current public health guidance, recruitment for this study has been paused.
13/09/2019: The trial contact was updated.
19/08/2019: The following changes were made to the trial record:
1. Trial website and trial participating centres added.
2. Interventions updated.
02/04/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Colorectal; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs" to "Colorectal cancer" following a request from the NIHR.
01/11/2017: Internal review.
23/02/2017: The study contact has been changed from Jennifer Wilkinson to Megan Jones.
24/01/2017: Cancer Help UK lay summary link added to plain English summary field.
