'Prehab' or 'Rehab'? Minimising the loss of lean body mass after curative gastrointestinal resection and speeding rehabilitation by exercise and optimised nutrition
| ISRCTN | ISRCTN17506204 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17506204 |
| Protocol serial number | N0077170542 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/02/2020
- 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 of protocol
Not provided at time of registration
Contact information
Prof M Larvin
Scientific
Scientific
Southern Derbyshire Acute Hospitals NHS Trust - DCGH
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 'Prehab' or 'Rehab'? Minimising the loss of lean body mass after curative gastrointestinal resection and speeding rehabilitation by exercise and optimised nutrition |
| Study objectives | To determine if patients scheduled for a curative resection of a gastrointestinal tumour are able to overcome the demands of surgery and metabolic derangements associated with it, more easily, following an optimized nutrition and resistance training programme. The expediated rehabilitation will be judged by body composition, cardiovascular and muscle function and anabolic responses of muscle and whole body protein metabolism. They will be compared with patients receiving only the current best standard care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Gastrointestinal |
| Intervention | During a routine NHS 76 patients who have been identified as suitable patients at MDT meetings and are agreeable to participating will receive informed consent. Screening investigations will be performed. Patients will be randomised into two groups; a treatment group and a control group. The treatment group will enter into an eight week fitness regimen consisting of resistance exercises for twenty minutes three times a week followed by a high energy/ high protein food bar. The control group will receive advice on nutrition and exercise alone. There will be two study days for all patients in the study. These will be separated and may be either pre and post intervention of pre and post operative. On each study day DEXA scanning will be performed and fractional synthetic rate determined in fasted and fed states. All subjects will attend 7 days after their last acute study. A general examination will be performed with particular attention pain to sites of cannulation and muscle biopsies. Recent similar studies have attracted large numbers of patients, suggesting that they will be recruitable. Opinions from patients with gastrointestinal cancer have been obtained regarding the study design and information sheets. |
| Intervention type | Other |
| Primary outcome measure(s) |
Difference in factional synthetic rate as determined by incorporation of leucine and D%-Phenyalanine between treatment group and control group. Quantification of NFf>>B expression, mTOR and p70S6 kinase phosphorylation and protein expression in muscle samples by western analysis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 76 |
| Key inclusion criteria | During a routine NHS visit 76 patients who have been identified as suitable patients at multidisciplinary team (MDT) meetings and are agreeable to participating will receive informed consent. Inclusion Criteria: patients with curative colonic cancer. |
| Key exclusion criteria | 1. Metastatic disease 2. Too weak to manage the exercise 3. Unable to give informed consent 4. Patients with insufficient command of the English language 5. Patients taking steroids or betablockers |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust - DCGH
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/02/2020: No publications found. All search options exhausted.
