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

Not Applicable

Completed

Conditions: Chronic Obstructive Pulmonary Disease
Respiratory

Registration Number: ISRCTN99038914

Lead Sponsor: niversity of Exeter (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Total score on Chronic Respiratory Disease Questionnaire, measured at baseline, weeks 9, 13, 25, 52<br><br>Timepoints:<br>Visit 1: Study Week (-5): Screening assessment<br>Visit 2: Study Week 0: Baseline/randomisation <br>Visit 3: Study Week 9: End of 8 week intervention period<br>Study Week 13: 3 months post-baseline questionnaire survey<br>Visit 4: Study Week 25: 6 month post-baseline follow-up assessment<br>Visit 5: Study Week 52: 12 months post-baseline follow-up assessment

Secondary Outcome Measures