Lung Diseases Clinical Trial
Official title:
Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.
Verified date | May 2015 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The Public Health Agency of Canada estimates that over 3.5 million Canadians live with
chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep
apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of
chronic lung disease among Canadian provinces, likely a reflection of both the age of the
population and high rates of exposures to occupational dusts and smoking. Pulmonary
rehabilitation is a multidisciplinary intervention, involving exercise and education for
patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to
improve patient symptoms, exercise capacity, and quality of life while reducing health
resource utilization. Many studies have shown that the benefits of pulmonary rehabilitation
tend to diminish over time after program completion. The best interventions to maintain the
benefits of pulmonary rehabilitation remain unclear.
The purpose of this study is to validate incorporation of an exercise DVD into a maintenance
program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from
pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual
care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study
subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion
of pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome
measures will include exercise capacity, exercise compliance, health-related quality of
life, confidence with performing exercise, and satisfaction with the exercise DVD. The
primary outcome measure will be a change in functional exercise capacity as determined by
the distance walked in 6-minutes, a commonly used and validated assessment tool for patients
with chronic lung disease.
Status | Completed |
Enrollment | 90 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - any participant enrolled in pulmonary rehabilitation program Exclusion Criteria: - Patients who do not have access to a DVD player. - Inability to commit to the study plan. - Cognitive or language barriers interfering with completion of the study procedures |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Cobequid Community Health Centre | Lower Sackville | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority | Capital Health, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6MWD | 6 months | No | |
Secondary | disease-specific quality of life (CRQ) | 6 months | No | |
Secondary | exercise compliance | 6 months | No | |
Secondary | exercise self-efficacy | 6 months | No | |
Secondary | subject satisfaction | 6 months | No |
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