Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Adrian Taylor
ORCID ID
Contact details
School of Sport and Health Sciences
St. Luke's Campus
University of Exeter
Magdalen Road
Exeter
EX1 2LU
United Kingdom
+44 (0)1392 264747
a.h.taylor@ex.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
200601
Study information
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
Acronym
HEALTH
Study hypothesis
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
Devon and Torbay Research Ethics Committee, 05/06/2007, ref: 07/Q2102/42
Study design
Single-centre single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/11/2007
Overall trial end date
30/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/11/2007
Recruitment end date
30/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Exeter
Exeter
EX1 2LU
United Kingdom
Sponsor information
Organisation
University of Exeter (UK)
Sponsor details
Northcote House
The Queen's Drive
Exeter
EX4 4QJ
United Kingdom
+44 (0)1392 661000
a.c.richards@exeter.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
International Primary Care Respiratory Group (UK) (ref: 200601)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 feasibility results in: http://www.ncbi.nlm.nih.gov/pubmed/20126968
Publication citations
-
Results
Faulkner J, Walshaw E, Campbell J, Jones R, Taylor R, Price D, Taylor AH, The feasibility of recruiting patients with early COPD to a pilot trial assessing the effects of a physical activity intervention., Prim Care Respir J, 2010, 19, 2, 124-130, doi: 10.4104/pcrj.2010.00008.