A randomised controlled trial of an intervention to promote the effects of Health Enhancing Physical Activity (HEPA) on physical and psychosocial outcomes in patients with mild Chronic Obstructive Pulmonary Disease (COPD) who are being treated with tiotropium
| ISRCTN | ISRCTN99038914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99038914 |
| Secondary identifying numbers | 200601 |
- Submission date
- 24/09/2007
- Registration date
- 13/02/2008
- Last edited
- 13/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims?
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases. People with COPD have difficulties breathing due to the narrowing of their airways. Pulmonary rehabilitation (PR) is a programme of exercise and education that is recommended to help patients with COPD. The aim of this study was to determine the additional effect of a PR programme on patients with mild COPD who are taking tiotropium (a drug that widens the airways in the lungs).
Who can participate?
Adult patients with mild COPD.
What does the study involve?
Patient records from local GP practices were searched to identify early-stage COPD patients. All patients were prescribed tiotropium for a minimum of 4 weeks before attending an assessment where their height and weight were measured and they underwent a lung function test and a walking test. Study questionnaires were also completed. Participants were then randomly allocated to one of two groups. One group took part in 8 weeks of once weekly, 90-minute supervised exercise and education sessions and were also encouraged to take part in a home-based exercise program. An exercise diary and pedometer was used to record home-based exercise participation. The other group were requested to continue normal care as instructed by their GP. All participants then took part in a follow-up assessment.
What are the possible benefits and risks of participating?
The benefits of taking part included regular physical activity under the guidance of a trained exercise practitioner. The education sessions were also deemed valuable as they were used to increase participants’ awareness of how to manage the symptoms of COPD. There are no known risks associated with participating in this study.
Where was the study run from?
University of Exeter (UK).
When is the study starting and how long is it expected to run for?
The study started in 2007. GP practice and participant recruitment was completed in 2009, with study findings published in 2010.
Who is funding the study?
The International Primary Care Respiratory Group (UK).
Who is the main contact?
Professor Adrian Taylor
A.H.Taylor@ex.ac.uk
Contact information
Scientific
School of Sport and Health Sciences
St. Luke's Campus
University of Exeter
Magdalen Road
Exeter
EX1 2LU
United Kingdom
| Phone | +44 (0)1392 264747 |
|---|---|
| a.h.taylor@ex.ac.uk |
Study information
| Study design | Single-centre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of an intervention to promote the effects of Health Enhancing Physical Activity (HEPA) on physical and psychosocial outcomes in patients with mild Chronic Obstructive Pulmonary Disease (COPD) who are being treated with tiotropium |
| Study acronym | HEALTH |
| Study objectives | Chronic Obstructive Pulmonary Disease encompasses chronic bronchitis, emphysema, chronic obstructive airways disease, chronic airflow limitation, and some cases of chronic asthma. The disease is chronic, slowly progressive, irreversible and debilitating, and has a devastating effect on individuals, causing significant mortality and morbidity and carrying a huge cost to both the health service and society. The symptoms of Chronic Obstructive Pulmonary Disease include increasing breathlessness and fatigue which gradually removes the individual's ability to partake in everyday activities such as walking, shopping and even minor physical exertion. As patients tire quickly, progression of the disease requires significant modification to lifestyle and activity and has consequences on psychological well being, employment and finances with impacts on social functioning, family and mood. Hypothesis: What is the additional effect of a Health Enhancing Physical Activity programme (HEPA) on physiological and psychosocial outcomes in participants with mild Chronic Obstructive Pulmonary Disease (COPD) who are receiving tiotropium in accordance with National Institute for Clinical Excellence (NICE) guidelines? |
| Ethics approval(s) | Devon and Torbay Research Ethics Committee, 05/06/2007, ref: 07/Q2102/42 |
| Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease |
| Intervention | A single-centre, single-blind randomised controlled trial of participants with mild COPD randomised equally to health enhancing physical activity intervention or normal care. Health Enhancing Physical Activity Programme (HEPA): Once weekly exercise and education session for 8 weeks, delivered by a qualified Exercise Practitioner, with instruction on exercising at home, exercise diaries and pedometer. Control: Continuation of normal care from General Practitioner (GP). All participants will be followed up for a period of one year. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tiotropium |
| Primary outcome measure | 1. Maximal exercise capacity measured using an Incremental Shuttle Walking Test (ISWT), measured at screening assessment (baseline - 5 weeks), baseline, weeks 9, 25 and 52 2. Total score on Chronic Respiratory Disease Questionnaire, measured at baseline, weeks 9, 13, 25, 52 Timepoints: Visit 1: Study Week (-5): Screening assessment Visit 2: Study Week 0: Baseline/randomisation Visit 3: Study Week 9: End of 8 week intervention period Study Week 13: 3 months post-baseline questionnaire survey Visit 4: Study Week 25: 6 month post-baseline follow-up assessment Visit 5: Study Week 52: 12 months post-baseline follow-up assessment |
| Secondary outcome measures | 1. Spirometry including inspiratory capacity, measured at screening assessment (baseline - 5 weeks), baseline, weeks 9, 25, 52 2. MRC dyspnoea score, measured at screening assessment (baseline - 5 weeks), baseline, weeks 9, 25, 52 3. Questionnaires: 3.1. Lung Information Needs Questionnaire, measured at baseline, weeks 9, 25, 52 3.2. Chronic Respiratory Disease Questionnaire: domain scores, measured at baseline, weeks 9, 13, 25, 52 3.3. Hospital Anxiety and Depression Scale scores, measured at baseline, weeks 9, 13, 25, 52 Exploratory: 1. Self-efficacy to regulate exercise questionnaire, measured at baseline, weeks 9, 13, 25, 52 2. Seven Day Physical Activity Recall Questionnaire, measured at baseline, weeks 9, 13 , 25, 52 3. Physical Self Perception Questionnaire, measured at baseline, weeks 9, 13, 25, 52 4. Smoking Status Questionnaire, measured at baseline, weeks 9, 13, 25, 52 5. Perceived Autonomy Support measure (Health Care Climate Questionnaire), measured at week 9 Timepoints: Visit 1: Study Week (-5): Screening assessment Visit 2: Study Week 0: Baseline/randomisation Visit 3: Study Week 9: End of 8 week intervention period Study Week 13: 3 months post-baseline questionnaire survey Visit 4: Study Week 25: 6 month post-baseline follow-up assessment Visit 5: Study Week 52: 12 months post-baseline follow-up assessment |
| Overall study start date | 01/11/2007 |
| Completion date | 30/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Adult patients (male and female) with clinical diagnosis of mild COPD 2. Smoking history greater than 10 pack years 3. Suitable for treatment with tiotropium according to NICE guidelines 4. Willing and able to undertake a health enhancing physical activity programme |
| Key exclusion criteria | 1. Body Mass Index (BMI) greater than 30 or less than 18 kg/m^2 2. History of asthma 3. Recent respiratory tract infection 4. Oxygen desaturation at rest less than 90% 5. Presence of serious co-morbid condition (orthopaedic, cardiovascular, muscular or neurological condition) that would interfere with regular exercise training 6. Prior participation in a pulmonary rehabilitation programme |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 30/04/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
EX1 2LU
United Kingdom
Sponsor information
University/education
Northcote House
The Queen's Drive
Exeter
EX4 4QJ
England
United Kingdom
| Phone | +44 (0)1392 661000 |
|---|---|
| a.c.richards@exeter.ac.uk | |
| Website | http://www.exeter.ac.uk/ |
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | feasibility results | 01/06/2010 | Yes | No |
