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| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN99038914 |
| Date ISRCTN assigned | 13/02/2008 |
| Local reference number(s) | 200601 |
| Public 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 |
| Scientific title | |
| Acronym | HEALTH |
| Disease/condition/study domain | Chronic Obstructive Pulmonary Disease |
| 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? |
| Design/methodology | A single centre, single blind randomised controlled trial |
| Research ethics review | Ethics approval received from the Devon and Torbay Research Ethics Committee on the 5th June 2007 (ref: 07/Q2102/42). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 30/04/2009 |
| Status of trial | Ongoing |
| Target number of participants | 100 |
| 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 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. |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | International Primary Care Respiratory Group (UK) (ref: 200601) |
| Sponsor name | University of Exeter (UK) |
| Sponsor details | Northcote House The Queen's Drive Exeter United Kingdom EX4 4QJ |
| Sponsor telephone | +44 (0)1392 661000 |
| Sponsor email | a.c.richards@exeter.ac.uk |
| Sponsor website | http://www.exeter.ac.uk/ |
| Contact name | Prof Adrian Taylor |
| Contact details | School of Sport and Health Sciences St. Luke's Campus University of Exeter Magdalen Road Exeter United Kingdom EX1 2LU |
| Contact telephone | +44 (0)1392 264747 |
| Contact fax | +44 (0)1392 264726 |
| Contact email | a.h.taylor@ex.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN99038914 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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