Impact of smoking cessation on skeletal muscle
| ISRCTN | ISRCTN85191494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85191494 |
| Secondary identifying numbers | 8238 |
- Submission date
- 14/07/2010
- Registration date
- 14/07/2010
- Last edited
- 21/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
| n.hopkinson@imperial.ac.uk |
Study information
| Study design | Single-centre observational non-randomised diagnosis and screening cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of smoking cessation on skeletal muscle atrophy and hypertrophy pathways in chronic obstructive pulmonary disease (COPD) |
| Study objectives | Our hypothesis is that smoking cessation in patients with chronic obstructive pulmonary disease (COPD) will lead to an increase in skeletal muscle bulk and endurance and that this will be associated with alterations in the pathways controlling skeletal muscle atrophy and hypertrophy including the Akt/FOXO/atrogene, mTOR and MyoD and myostatin pathways. We also propose that smoking cessation will lead to a more oxidative fibre type with an increase in the expression of type I myosin and reduction in the expression of type II myosin heavy chains. We will investigate this by making detailed assessment of skeletal muscle function and examining biopsies from the quadriceps muscle before and after smoking cessation. In parallel with this we will study the effect of smoking cessation on lung function, exercise capacity and systemic inflammation. |
| Ethics approval(s) | UCLH Committee Alpha approved, ref: 09/H0715/37 |
| Health condition(s) or problem(s) studied | Effect of smoking cessation on skeletal muscle strength in people with chronic obstructive pulmonary disease (COPD) and in smokers with normal lung function |
| Intervention | Smoking cessation advice, counselling and pharmacotherapy as clinically indicated. This may include NRT and varenicline. Outcomes will be assessed 8 weeks after the quit date. |
| Intervention type | Mixed |
| Primary outcome measure | Current primary outcome measure as of 18/10/2019: Dynamic hyperinflation during cycle ergometry measured at 8 weeks after quit date Previous primary outcome measure: Activity of the IGF-1 PI3K/Akt/FOXO/atrogene pathway and the mTOR pathway in muscle biopsy specimens, measured at 8 weeks after quit date |
| Secondary outcome measures | Current secondary outcome measures as of 18/10/2019: Measured at 8 weeks after quit date: 1. Quadriceps endurance 2. Quadriceps strength Previous secondary outcome measures: Measured at 8 weeks after quit date: 1. Dynamic hyperinflation during cycle ergometry 2. MyoD and myostatin protein and mRNA levels 3. Quadriceps endurance 4. Quadriceps strength |
| Overall study start date | 01/11/2009 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 95; UK sample size: 95 |
| Key inclusion criteria | 1. Consenting adult smokers who wish to quit 2. Both COPD patients who smoke and smokers with normal lung function 3. Male and female, lower age limit of 18 years |
| Key exclusion criteria | The presence of significant co-morbidity judged likely to have a significant impact on muscle strength |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 01/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SW3 6NP
United Kingdom
Sponsor information
University/education
Imperial College
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research council
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 | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
21/01/2020: The condition has been changed from "Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal" to "Effect of smoking cessation on skeletal muscle strength in people with chronic obstructive pulmonary disease (COPD) and in smokers with normal lung function" following a request from the NIHR.
18/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/08/2012 to 01/10/2020.
2. The intention to publish date was added.
3. The primary outcome measure was changed.
4. The secondary outcome measures were changed.
5. IPD sharing statement added to publication and dissemination plan.
16/01/2019: The overall trial end date was changed from 15/08/2012 to 01/10/2020.
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
