Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

Phase 3

Completed

• Conditions: Lung Diseases
• Interventions: Device: Exercise DVD; Behavioral: Usual Care

• Registration Number: NCT01235481
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Study Start: 2010-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise DVD	Exercise DVD	Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
Exercise DVD	Usual Care	Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
Usual Care	Usual Care	Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD

Primary Outcome Measures

Name	Time	Method
6MWD	6 months

Secondary Outcome Measures

Name	Time	Method
disease-specific quality of life (CRQ)	6 months
subject satisfaction	6 months
exercise compliance	6 months
exercise self-efficacy	6 months

Trial Locations

Locations (2)

Cobequid Community Health Centre; 🇨🇦 Lower Sackville, Nova Scotia, Canada

QEII Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada