Chronic Obstructive Pulmonary DiseaseNCT02086383
Physical Activity and Self-Efficacy After Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by University College, London at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Aug 2014
- How long will I take part?
- 10 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry
Who may be able to join
- 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.
- A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. Thomas' Hospital
City of Westminster, London, SE1 7EH
Noor Diana Mohamed Sani, 4407852599168, noor.sani.13@ucl.ac.uk
Noor Diana Mohamed Sani
About this study
Official title: Short Term Effects of Pulmonary Rehabilitation on Level of Physical Activity and Self-Efficacy in Patients With Chronic Obstructive Pulmonary Disease.
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.
Read more
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.
Read the detailed 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.
- 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.
- Written consent will be taken on initial assessment if patient agrees to participate in the study.
- 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.
- 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.
- 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation, Self-Efficacy, Physical Activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, and after pulmonary rehabilitation program (approx Week 10)
Secondary outcomes (3)
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.
Measured: Baseline, and after pulmonary rehabilitation program (approx Week 10)
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.
Measured: Baseline, and after pulmonary rehabilitation program (approx Week 10)
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.
Measured: Baseline, and after pulmonary rehabilitation program (approx Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Principal investigator, Noor Diana Binte Mohamed Sani, University College, London
- Investigators
- Noor Diana Mohamed Sani, Principal investigator, University College, LondonLeyla Osman, Dr, Study chair, University College London, Guy's and St. Thomas' HospitalLynn McDonnell, MSc, Study director, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086383
- Sponsor's protocol ID
- 5380/001
- Status last verified
- May 2014
- First submitted
- 11 Mar 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Pulmonary Rehabilitation on Level of Physical Activity and Self-Efficacy in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT02086383
- Acronym / sponsor ID
- 5380/001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation, Self-Efficacy, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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.
- Written consent will be taken on initial assessment if patient agrees to participate in the study.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves patients with chronic obstructive pulmonary disease (COPD), whose diagnosis is confirmed by spirometry
Key inclusion criteria (5 listed)
- Patients who fulfill the current inclusion criteria for referral to pulmonary rehabilitation in Guy's and St Thomas' Hospital.
- A diagnosis of COPD confirmed by spirometry (Forced Expiratory Volume in 1 second/Forced Vital Capacity < 0.70 after bronchodilator) (GOLD, 2014)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in physical activity level after pulmonary rehabilitation
Time frame: Baseline measurement and after the program (approx Week 10)
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.
Change in level of Self-Efficacy using the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) questionnaire scores
Time frame: Baseline, and after pulmonary rehabilitation program (approx Week 10)
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.
3 secondary outcomes
Change in 6-Minute Walk Test distance after pulmonary rehabilitation
Time frame: Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in Hospital Anxiety and Depression Scale (HADS) questionnaire score
Time frame: Baseline, and after pulmonary rehabilitation program (approx Week 10)
Change in COPD Assessment Test score
Time frame: Baseline, and after pulmonary rehabilitation program (approx Week 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- The use of accelerometers to measure level of physical activity in patients with COPDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noor Diana Mohamed Sani principal investigator
University College, London
Leyla Osman, Dr study chair
University College London, Guy's and St. Thomas' Hospital
Lynn McDonnell, MSc study director
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noor Diana Mohamed Sani (4407852599168, noor.sani.13@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity level after pulmonary rehabilitation (time frame: Baseline measurement and after the program (approx Week 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.