Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235481
• Other study ID #: CDHA-RS/2011-159
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2010
• Last updated: May 12, 2015
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• Exercise DVD
Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation

Behavioral:
• Usual Care
Usual care during maintenance phase post pulmonary rehabilitation

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Cobequid Community Health Centre	Lower Sackville	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Capital Health, Canada

Country where clinical trial is conducted

Canada, 

Outcome

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