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Completed

NCT Number: NCT01235481

Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise DVD

Device

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

Other names: Home exercise training

Usual Care

Behavioral

Usual care during maintenance phase post pulmonary rehabilitation

Other names: No exercise DVD provided

Primary outcomes

  1. 6MWD

    Time frame: 6 months

Secondary outcomes

  1. disease-specific quality of life (CRQ)

    Time frame: 6 months

  2. exercise compliance

    Time frame: 6 months

  3. exercise self-efficacy

    Time frame: 6 months

  4. subject satisfaction

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Capital Health, Canada

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2010
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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