Impact of smoking cessation on skeletal muscle

ISRCTN	ISRCTN85191494
DOI	https://doi.org/10.1186/ISRCTN85191494
Protocol serial number	8238
Sponsor	Imperial College London (UK)
Funder	Medical Research Council (MRC) (UK)

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

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

Dr Nick Hopkinson
Scientific

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom

Email	n.hopkinson@imperial.ac.uk

Study information

Primary study design	Observational
Study design	Single-centre observational non-randomised diagnosis and screening cohort study
Secondary study design	Cohort study
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Royal Brompton Hospital

London
SW3 6NP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

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

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.