Chronic Obstructive Pulmonary Disease Respiratory Chronic Obstructive Pulmonary Disease
Conditions
Interventions
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 Physica
Sponsors
University of Exeter (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed