Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

May 12, 2015 updated by: Paul Hernandez, Nova Scotia Health Authority

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
      • Lower Sackville, Nova Scotia, Canada, B4C 0A2
        • Cobequid Community Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Home exercise training
Behavioral: Usual Care
Usual care during maintenance phase post pulmonary rehabilitation
Other Names:
  • No exercise DVD provided
OTHER: 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 Names:
  • No exercise DVD provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6MWD
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
disease-specific quality of life (CRQ)
Time Frame: 6 months
6 months
exercise compliance
Time Frame: 6 months
6 months
exercise self-efficacy
Time Frame: 6 months
6 months
subject satisfaction
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Capital Health, Canada

Investigators

  • Principal Investigator: Paul Hernandez, MDCM, FRCPC, Queen Elizabeth Ii Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (ESTIMATE)

November 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RS/2011-159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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