Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

This study has been completed.
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: May 12, 2015
Last verified: May 2015
  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.

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • 6MWD [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: December 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235481

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Cobequid Community Health Centre
Lower Sackville, Nova Scotia, Canada, B4C 0A2
Sponsors and Collaborators
Nova Scotia Health Authority
Capital Health, Canada
Investigators
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: May 12, 2015
Health Authority: Canada: Health Canada

Keywords provided by Nova Scotia Health Authority:
pulmonary rehabilitation
exercise therapy
chronic lung disease
self-efficacy

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 30, 2015