Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Diseases |
Device: Exercise DVD Behavioral: Usual Care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial. |
- 6MWD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- disease-specific quality of life (CRQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- exercise compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- exercise self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- subject satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exercise DVD
Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
|
Device: Exercise DVD
Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation
Other Name: Home exercise training
Behavioral: Usual Care
Usual care during maintenance phase post pulmonary rehabilitation
Other Name: No exercise DVD provided
|
|
Usual Care
Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD
|
Behavioral: Usual Care
Usual care during maintenance phase post pulmonary rehabilitation
Other Name: No exercise DVD provided
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Paul Hernandez, MDCM, FRCPC | 902-473-3698 | paul.hernandez@cdha.nshealth.ca |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Contact: Deanna Landry, BScPT 902-473-7855 | |
| Principal Investigator: Paul Hernandez, MDCM, FRCPC | |
| Cobequid Community Health Centre | Recruiting |
| Lower Sackville, Nova Scotia, Canada, B4C 0A2 | |
| Contact: Cindy Clark, BScPT 902-869-6117 cindy.clark@cdha.nshealth.ca | |
| Principal Investigator: | Paul Hernandez, MDCM, FRCPC | QEII Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Paul Hernandez, Principle Investigator, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT01235481 History of Changes |
| Other Study ID Numbers: | CDHA-RS/2011-159 |
| Study First Received: | November 4, 2010 |
| Last Updated: | October 24, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Capital District Health Authority, Canada:
|
pulmonary rehabilitation exercise therapy chronic lung disease self-efficacy |
Additional relevant MeSH terms:
|
Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013