Muscle wasting in chronic obstructive pulmonary disease (COPD): the role of resistance training and protein supplementation
| ISRCTN | ISRCTN22764439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22764439 |
| Secondary identifying numbers | MRC ref: G0501985; UHL 10146 |
- Submission date
- 21/10/2009
- Registration date
- 09/12/2009
- Last edited
- 25/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Steiner
Scientific
Scientific
Consultant Respiratory Physician
University Hospitals of Leicester NHS Trust
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 256 3450 |
|---|---|
| michael.steiner@uhl-tr.nhs.uk |
Study information
| Study design | Double-blind randomised placebo-controlled single-centre trial |
|---|---|
| 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 | Molecular approaches to reversing skeletal muscle wasting in chronic obstructive pulmonary disease (COPD): the role of resistance training and protein supplementation - a double-blind randomised placebo-controlled trial |
| Study objectives | This project will test the following principal hypotheses: 1. That muscle wasting in chronic obstructive pulmonary disease (COPD) is characterised by alterations in the expression of catabolic and anabolic genes (mRNA) and signalling pathways (protein and protein phosphorylation) that have been implicitly associated with the regulation of skeletal muscle protein degradation and synthesis when compared with non-wasted COPD patients, and similar aged healthy controls. 2. That a carefully controlled resistance training programme known to restore muscle mass in immobilised young healthy humans will have similar restorative effects in COPD patients and that these benefits will be mediated through changes in these candidate gene and signalling pathways. We will also determine how these effects differ between wasted and non wasted COPD patients and between patients and healthy controls. 3. That changes in the expression and activation of these regulatory pathways occurs early (within 24 hours) from the onset of rehabilitation as was seen following limb immobilisation in young healthy subjects. 4. That the positive effects of resistance training on skeletal muscle mass in COPD patients can be augmented when training is combined with dietary protein supplementation. More details can be found at the following links: UK Clinical Research Network Study Portfolio: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4049 MRC research portfolio: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0501985&CaseId=6937 |
| Ethics approval(s) | 1. Leicestershire, Northamptonshire & Rutland Research Ethics Committee 1, 26/09/2006, ref: 06/Q2501/138 2. University Hospitals of Leicester (UHL) NHS Trust R&D, 05/01/2007, ref: 10146 3. Leicester City Primary Care Trust (PCT), 12/02/2008, ref: LNR PCRA 0696 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | 1. Resistance training: The training programme will last 8 weeks and comprise three supervised half-hour lower limb resistance training sessions per week. Training will take place on an isokinetic dynamometer (Cybex II Norm: CSMi, USA). Subjects will perform 5 sets of 30 maximal knee extensions performed at 180 degrees/sec. Sets will be separated by 1 minute rest. Both legs will be trained. 2. Protein supplementation: COPD patients will be randomly allocated to receive a dietary protein (with carbohydrate) supplement or placebo throughout training. Healthy volunteers will receive a placebo. The supplement will contain 19 g protein and 49 g carbohydrate (Vitargo® Gainers Gold: Swecarb, Sweden) made up to 500 ml of water. The placebo will be an identical volume non-nutritive and non-caloric drink. Supplementation will take place immediately following each training session, as the timing of protein intake appears to be critical. |
| Intervention type | Mixed |
| Primary outcome measure | Muscle gene and protein expression (vastus lateralis needle biopsy samples) at baseline, 24 hours, 4 weeks and 8 weeks. |
| Secondary outcome measures | 1. Muscle strength (isometric and isokinetic quadriceps strength) at baseline, 4 weeks, 8 weeks and 6 months 2. Total body and quadriceps fat-free (muscle) mass (dual energy X-ray absorptiometry [DEXA]) at baseline, 4 weeks and 8 weeks 3. Circulating inflammatory cytokines (blood tests) at baseline, 24 hours, 4 weeks and 8 weeks 4. Whole-body exercise performance (incremental cycle ergometry test) at baseline and 8 weeks 5. Physical activity (questionnaire and activity monitor) at baseline and 8 weeks 6. Lung function and capillary blood gas tensions at baseline |
| Overall study start date | 14/02/2007 |
| Completion date | 31/10/2010 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | For both COPD subjects and healthy control subjects: 1. Both males and females, aged between 50-85 years COPD subjects: 1. Moderate-severe airflow obstruction (Forced expiratory volume in one second [FEV1] <50% predicted, FEV1/forced vital capacity [FVC] ratio <70%) 2. Reduced exercise tolerance (MRC grades III-V) 3. Stable 4. Able to carry out lower-limb resistance training Healthy age-matched control subjects: 1. No evidence of airflow obstruction (FEV1 >80% predicted) 2. Able to carry out lower-limb resistance training |
| Key exclusion criteria | COPD subjects: 1. Long-term oral corticosteriods 2. Anticoagulant therapy or disorders 3. long term oxygen therapy (LTOT) 4. Diabetes 5. Co-morbid conditions preventing exercise training 6. Subects who have completed pulmonary rehabilitation in the previous 12-months Healthy age-matched controls: Same as for COPD subjects, also those who meet the criteria for fat-free mass depletion are excluded. |
| Date of first enrolment | 14/02/2007 |
| Date of final enrolment | 31/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
LE3 9QP
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Offices
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| carolyn.maloney@uhl-tr.nhs.uk | |
| Website | http://www.uhl-tr.nhs.uk |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
Medical Research Council (ref: G0501985; grant ID: 77170)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results (inflammatory and satellite cells in the quadriceps) | 01/11/2012 | Yes | No | |
| Results article | results (ultrasound assessment of lower limb muscle mass) | 28/12/2012 | Yes | No | |
| Results article | results (ventilatory requirements of quadriceps resistance training) | 05/06/2014 | Yes | No |
