Condition category
Cancer
Date applied
07/07/2016
Date assigned
07/07/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Miss Jennifer Wilkinson

ORCID ID

Contact details

Norwich Medical School
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 1603 591224
J.Wilkinson@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30965

Study information

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

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

22/06/2016, ref: 16/EE/0190

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural, Physical

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Cancer, Primary sub-specialty: Colorectal; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs

Intervention

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 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 sign posted 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 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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 statusis measured 6 and 12 months

Overall trial start date

01/11/2016

Overall trial end date

01/05/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1146; UK Sample Size: 1146

Participant exclusion criteria

1. Contra-indications to exercise (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 (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

01/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norwich Medical School
University of East Anglia Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

Norfolk and Norwich University Hospitals NHS Foundation Trust

Sponsor details

Colney Lane
Norwich
NR4 7UY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review