NCT02086383

Brief Summary

The purpose of this study is to investigate whether pulmonary rehabilitation (PR) is effective in increasing level of (a) physical activity (PA) and (b) self-efficacy in patients with chronic obstructive pulmonary disease (COPD). PR is an evidence-based multidisciplinary approach consisting primarily of a supervised exercise program with educational components. It has demonstrated high efficacy in improving dyspnoea, health-related quality of life (HRQoL) and functional exercise capacity in patients with COPD. Despite these improvements, there is no conclusive evidence that these benefits translate to an increase in PA in patient's day-to-day life. This is of concern as low PA is a predictor of all cause mortality, correlated with lower HRQoL, increased level of dyspnoea and higher number of hospital admissions in this group of patients. Self-efficacy is found to be an instigating force in forming intention to exercise and in maintaining practice for an extended time. Self-efficacy may be the key in determining whether a patient translates the improvement in exercise tolerance to actually being more physically active. Based on current knowledge, there is insufficient evidence that self-efficacy increases after pulmonary rehabilitation and no correlation has been made between level of self-efficacy and level of PA in these group of patients. Hence this study aims to find out whether the existing PR program increases level of PA and self-efficacy. Correlation between level of PA and self-efficacy will be made.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

March 11, 2014

Last Update Submit

May 27, 2014

Conditions

Keywords

Pulmonary RehabilitationSelf-EfficacyPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Change in physical activity level after pulmonary rehabilitation

    Physical activity is measured using the Actigraph accelerometer, which is a small light weight device clipped onto a waist belt. Its output is vector magnitude units, steps, energy expenditure and activity intensity level. Patients will wearing the device for 5 to 7 days, before and after the program. The pulmonary rehabilitation program consists of 14 sessions, twice a week.

    Baseline measurement and after the program (approx Week 10)

  • Change in level of Self-Efficacy using the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire scores

    Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire is a questionnaire measuring the level of self-efficacy. It consists of 15 questions on a 4-point scale. It takes less than 10 minutes to complete.

    Baseline, and after pulmonary rehabilitation program (approx Week 10)

Secondary Outcomes (3)

  • Change in 6-Minute Walk Test distance after pulmonary rehabilitation

    Baseline, and after pulmonary rehabilitation program (approx Week 10)

  • Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score

    Baseline, and after pulmonary rehabilitation program (approx Week 10)

  • Change in COPD Assessment Test score

    Baseline, and after pulmonary rehabilitation program (approx Week 10)

Study Arms (1)

Patients with COPD

This is an observational study of patients with chronic obstructive pulmonary disease (COPD) who attend pulmonary rehabilitation, which is the routine standard of care in Guy's and St. Thomas' Hospital, London. It lasts for 14 sessions, twice a week and primarily consists of a supervised exercise program and educational sessions.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry

You may qualify if:

  • Have chronic obstructive pulmonary disease or other respiratory conditions.
  • Are aware of the about the referral and details of the program.
  • Have consented and are able to attend the program.
  • A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity \< 0.70 after bronchodilator) (GOLD, 2014)

You may not qualify if:

  • No evidence of COPD on spirometry
  • Acute exacerbations within last 4-6 weeks requiring hospital admission
  • Evidence of ischemic heart disease/ acute changes on ECG
  • Uncontrolled hypertension
  • Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course or limit participation in the course
  • Lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Thomas' Hospital

City of Westminster, London, SE1 7EH, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Noor Diana Mohamed Sani

    University College, London

    PRINCIPAL INVESTIGATOR
  • Leyla Osman, Dr

    University College London, Guy's and St. Thomas' Hospital

    STUDY CHAIR
  • Lynn McDonnell, MSc

    Guy's and St Thomas' NHS Foundation Trust

    STUDY DIRECTOR

Central Study Contacts

Noor Diana Mohamed Sani

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc Student in Advanced Physiotherapy: Cardiorespiratory Course

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 13, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations