- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235481
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation
Other Names:
Usual care during maintenance phase post pulmonary rehabilitation
Other Names:
|
OTHER: Usual Care
Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD
|
Usual care during maintenance phase post pulmonary rehabilitation
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Hernandez, MDCM, FRCPC, Queen Elizabeth II Health Sciences Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Clinical Trials on Lung Diseases
-
Guangzhou Institute of Respiratory DiseaseUnknownInterstitial Lung Disease | Transbronchial Lung Cryobiopsy | Surgical Lung Biopsy
-
Aveiro UniversityFundação para a Ciência e a TecnologiaNot yet recruitingInterstitial Lung DiseasesPortugal
-
RWTH Aachen UniversityCompletedObstructive Lung DiseasesGermany
-
Bastiaan DriehuysNational Heart, Lung, and Blood Institute (NHLBI); University of Iowa; Children... and other collaboratorsRecruitingInterstitial Lung DiseasesUnited States
-
Shanghai East HospitalRegend TherapeuticsCompletedInterstitial Lung DiseasesChina
-
China-Japan Friendship HospitalXiangya Hospital of Central South University; Peking Union Medical College... and other collaboratorsUnknown
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedInterstitial Lung DiseasesNetherlands
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Aveiro UniversityFundação para a Ciência e a Tecnologia; Centro Hospitalar do Baixo VougaRecruitingInterstitial Lung Diseases (ILD)Portugal
-
China-Japan Friendship HospitalNot yet recruitingTransbronchial Lung Cryobiopsy
Clinical Trials on Exercise DVD
-
University of HawaiiKlein Buendel, Inc.CompletedMomZing Exercise Videos Online | Standard Exercise DVDUnited States
-
Idaho State UniversityCompletedObesity | Feeding Behavior | ImpulsivityUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
NYU Langone HealthCompletedPatellar Femoral SyndromeUnited States
-
The Miriam HospitalNational Institute of Mental Health (NIMH); Brown University; University of Rochester and other collaboratorsCompletedHIV Infections | Sexually Transmitted Diseases | HIVUnited States
-
Cooper Green Mercy HospitalUniversity of Alabama at BirminghamUnknownHypertensionUnited States
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongCompleted
-
VA Office of Research and DevelopmentCompleted
-
Georgetown UniversityNational Cancer Institute (NCI); University of California, Los Angeles; Temple...Completed
-
South Dakota State UniversityCompleted