Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

NCT ID: NCT01235481

Last Updated: 2015-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise DVD

Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training

Group Type EXPERIMENTAL

Exercise DVD

Intervention Type DEVICE

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

Usual Care

Intervention Type BEHAVIORAL

Usual care during maintenance phase post pulmonary rehabilitation

Usual Care

Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

Usual care during maintenance phase post pulmonary rehabilitation

Interventions

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Exercise DVD

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

Intervention Type DEVICE

Usual Care

Usual care during maintenance phase post pulmonary rehabilitation

Intervention Type BEHAVIORAL

Other Intervention Names

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Home exercise training No exercise DVD provided

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Health, Canada

OTHER

Sponsor Role collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Paul Hernandez

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Hernandez, MDCM, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth II Health Sciences Centre

Locations

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QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Cobequid Community Health Centre

Lower Sackville, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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CDHA-RS/2011-159

Identifier Type: -

Identifier Source: org_study_id

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