Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

Study Overview
=================
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.

Official Title
-----------------
Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Device: Exercise DVD
* Behavioral: Usual Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise DVD<br>Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training | Device: Exercise DVD<br>* Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation<br>* Other names: Home exercise training;Behavioral: Usual Care<br>* Usual care during maintenance phase post pulmonary rehabilitation<br>* Other names: No exercise DVD provided;|
| Other: Usual Care<br>Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD | Behavioral: Usual Care<br>* Usual care during maintenance phase post pulmonary rehabilitation<br>* Other names: No exercise DVD provided;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWD |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-specific quality of life (CRQ) |  | 6 months | 
| exercise compliance |  | 6 months | 
| exercise self-efficacy |  | 6 months | 
| subject satisfaction |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary rehabilitation, exercise therapy, chronic lung disease, self-efficacy