Clinical trial NCT01235481: Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
Official title: Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Diseases
Keywords: pulmonary rehabilitation
exercise therapy
chronic lung disease
self-efficacy
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Capital Health, Canada
First posted: 2010-11-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 6MWD
timeFrame: 6 months
Secondary outcomes:
measure: disease-specific quality of life (CRQ)
timeFrame: 6 months
measure: exercise compliance
timeFrame: 6 months
measure: exercise self-efficacy
timeFrame: 6 months
measure: subject satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Lower Sackville
country: Canada
facility: Cobequid Community Health Centre
state: Nova Scotia
Study officials:
affiliation: Queen Elizabeth II Health Sciences Centre
name: Paul Hernandez, MDCM, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: