Condition category
Musculoskeletal Diseases
Date applied
14/07/2010
Date assigned
14/07/2010
Last edited
21/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nick Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
-
n.hopkinson@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8238

Study information

Scientific title

Impact of smoking cessation on skeletal muscle atrophy and hypertrophy pathways in chronic obstructive pulmonary disease (COPD)

Acronym

Study hypothesis

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

UCLH Committee Alpha approved, ref: 09/H0715/37

Study design

Single-centre observational non-randomised diagnosis and screening cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

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

Phase

Drug names

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 trial start date

01/11/2009

Overall trial end date

01/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 95; UK sample size: 95

Participant exclusion criteria

The presence of significant co-morbidity judged likely to have a significant impact on muscle strength

Recruitment start date

01/11/2009

Recruitment end date

01/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Imperial College
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/10/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

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.