Physical Activity and Self-Efficacy After Pulmonary Rehabilitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Short Term Effects of Pulmonary Rehabilitation on Level of Physical Activity and Self-Efficacy in Patients With Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086383
• Other study ID #: 5380/001
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2014
• Last updated: May 27, 2014
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: May 2014
• Source: University College, London
• Contact: Noor Diana Mohamed Sani
• Phone: 4407852599168
• Email: noor.sani.13[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health ServiceUnited Kingdom: National Institute for Health Research
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The intervention group will consist of all patients with chronic obstructive pulmonary disease (COPD) referred to Guy's and St Thomas' Hospital (GSTT) pulmonary rehabilitation. A sample of 30 is anticipated as this is the maximum number of patients who could be enrolled in the 3 month recruitment period in Guy's and St. Thomas' Hospital.

1. The patient information sheet, together with the referral for PR, will be posted to the patients. Patients will be informed about the study details in the patient information sheet. This will include the fact that they have to wear an accelerometer for 5 to 7 days prior to starting the program. These accelerometers will be collected thereafter. Instructions on the use of the accelerometers will be given. They will also be informed that any personal information will strictly be kept confidential and that the results will be used for analysis in the study.

2. Written consent will be taken on initial assessment if patient agrees to participate in the study.

3. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire will be administered. It consists of 15 questions and will take less than 10 minutes to complete.

4. The patient will undertake 14 sessions of PR under supervision to successfully complete the program. The program is held at Guy's and St Thomas' Hospital.

5. The PRAISE questionnaire will be administered again after completion of the program. Patients will be asked to wear the accelerometers again to track their physical activity. After 5 to 7 days of use, the accelerometers will be collected either from their address or via stamped postage.

No changes will be made to the current pulmonary rehabilitation program.

No control group is present in the study as pulmonary rehabilitation is the standard of care and it is not ethical to withhold pulmonary rehabilitation from patients with COPD.

The null hypothesis would be that there is no difference in physical activity and self-efficacy before and after pulmonary rehabilitation. The statistical test used will be a paired sample t-test to determine the change in a) physical activity and b)self-efficacy after pulmonary rehabilitation.

Correlation analysis will be made between self-efficacy and physical activity with a) Anxiety and depression (Hospital anxiety and depression scale), b)Functional exercise capacity (6 minute walk test) and c) COPD Assessment test.

A Pearson or Spearman correlations will be done depending on whether or not the data is normally distributed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients who fulfill the current inclusion criteria for referral to pulmonary rehabilitation in Guy's and St Thomas' Hospital.

• 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.

2. A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)

Exclusion Criteria:

1. No evidence of COPD on spirometry

2. Acute exacerbations within last 4-6 weeks requiring hospital admission

3. Evidence of ischemic heart disease/ acute changes on ECG

4. Uncontrolled hypertension

5. Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course or limit participation in the course

6. Lung cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	St. Thomas' Hospital	City of Westminster	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Change in 6-Minute Walk Test distance after pulmonary rehabilitation	The 6-Minute Walk Test is a test of functional exercise capacity which is routinely used in pulmonary rehabilitation programs.	Baseline, and after pulmonary rehabilitation program (approx Week 10)	No
Secondary	Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score	HADS consists of 14 questions and takes less than 10 minutes to complete. It measures the level of anxiety and depression.	Baseline, and after pulmonary rehabilitation program (approx Week 10)	No
Secondary	Change in COPD Assessment Test score	The COPD Assessment Test is an 8-item questionnaire which determines the impact of chronic obstructive pulmonary disease on the patient's wellbeing and daily life. It takes less than 5 minutes to complete.	Baseline, and after pulmonary rehabilitation program (approx Week 10)	No

External Links

•   Determinants and outcomes of physical activity in patients with COPD: a systematic review
•   measurement of self-efficacy after pulmonary rehabilitation in patients with COPD
•   Overview on pulmonary rehabilitation
•   The use of accelerometers to measure level of physical activity in patients with COPD