Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Capital Health, Canada
Information provided by (Responsible Party):
Paul Hernandez, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01235481
First received: November 4, 2010
Last updated: October 24, 2012
Last verified: October 2012

November 4, 2010
October 24, 2012
December 2010
June 2013   (final data collection date for primary outcome measure)
6MWD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01235481 on ClinicalTrials.gov Archive Site
  • 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 ]
  • disease-specific qulaity 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 ]
Not Provided
Not Provided
 
Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Lung Diseases
  • 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
  • Experimental: Exercise DVD
    Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
    Interventions:
    • Device: Exercise DVD
    • Behavioral: Usual Care
  • Usual Care
    Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Paul Hernandez, MDCM, FRCPC 902-473-3698 paul.hernandez@cdha.nshealth.ca
Canada
 
NCT01235481
CDHA-RS/2011-159
No
Paul Hernandez, Capital District Health Authority, Canada
Capital District Health Authority, Canada
Capital Health, Canada
Principal Investigator: Paul Hernandez, MDCM, FRCPC QEII Health Sciences Centre
Capital District Health Authority, Canada
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP