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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00542932
Other study ID # 05/Q0703/151
Secondary ID
Status Completed
Phase Phase 2
First received October 11, 2007
Last updated October 11, 2007
Start date October 2005
Est. completion date October 2006

Study information

Verified date October 2007
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial Summary

Patients with COPD, suffer symptoms of breathlessness and leg weakness. Exercise programmes in the form of pulmonary rehabilitation (PR) have been shown to improve both of these symptoms significantly. PR involves patients attending a hospital or community centre. For some patients, leaving the house is an ordeal. This study investigated the effectiveness of an exercise video programme delivered in the patients home.


Description:

Pulmonary Rehabilitation (PR) has been shown to deliver cost-effective improvements in dyspnoea, exercise tolerance and health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD). PR programmes in the United Kingdom (UK) are typically delivered on an outpatient basis, either at a hospital or suitable site in the community. It is not always possible however, for patients to access outpatient programmes due to lack of local availability or adequate transport from isolated locations. Severe breathlessness may reduce activity levels to such a degree that for many leaving the house is an ordeal. A British Lung Foundation (BLF) survey reported that less than 2% of UK COPD patients had access to a rehabilitation exercise programme, despite National Institute for Health and Clinical Excellence (NICE) and British Thoracic Society (BTS) recommendations that PR be made available to all patients who are functionally limited by dyspnoea. Meeting the demand for PR remains a challenge.

Access to the benefits of PR may be broadened if effective exercise could be administered at home. Current evidence suggests that home-based rehabilitation interventions result in smaller benefits as judged by exercise tolerance and quality of life when compared to supervised programmes. The impact of home based rehabilitation may be limited by multiple factors including, lack of health care professional supervision and lack of support from fellow COPD sufferers. This lack of support may lead to poor adherence to prescribed exercise intensity and frequency in home programmes.

One-to-one supervision on an individual basis is unlikely to be feasible or cost-effective, however, use of a home exercise video could enhance adherence to prescribed exercise programmes. Video media can be an effective means of delivering exercise instruction. No published research to date has investigated the effectiveness of a home exercise video for patients with COPD. We hypothesised that an exercise programme based on video instruction at home, could improve walking ability, breathlessness and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Moderate/severe COPD

- Access to a video or DVD player

Exclusion Criteria:

- Comorbid condition that precludes safe exercise

- Previous attendance at a pulmonary rehabilitation programme

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Watched Film A (promotional film) Film B (30 min exercise video) asked to to perform 4 times a week for 6 weeks at home

Locations

Country Name City State
United Kingdom King's College Hospital London

Sponsors (2)

Lead Sponsor Collaborator
King's College Hospital NHS Trust University of Brighton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incremental Shuttle Walk Test Baseline and 6 weeks
Secondary Chronic Respiratory Disease Questionnaire Baseline and 6 weeks
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