Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
Primary Purpose
Lung Diseases
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Exercise DVD
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring pulmonary rehabilitation, exercise therapy, chronic lung disease, self-efficacy
Eligibility 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
Sites / Locations
- QEII Health Sciences Centre
- Cobequid Community Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Exercise DVD
Usual Care
Arm Description
Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD
Outcomes
Primary Outcome Measures
6MWD
Secondary Outcome Measures
disease-specific quality of life (CRQ)
exercise compliance
exercise self-efficacy
subject satisfaction
Full Information
NCT ID
NCT01235481
First Posted
November 4, 2010
Last Updated
May 12, 2015
Sponsor
Nova Scotia Health Authority
Collaborators
Capital Health, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01235481
Brief Title
Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
Official Title
Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Capital Health, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
pulmonary rehabilitation, exercise therapy, chronic lung disease, self-efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise DVD
Arm Type
Experimental
Arm Description
Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training
Arm Title
Usual Care
Arm Type
Other
Arm Description
Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD
Intervention Type
Device
Intervention Name(s)
Exercise DVD
Other Intervention Name(s)
Home exercise training
Intervention Description
Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Other Intervention Name(s)
No exercise DVD provided
Intervention Description
Usual care during maintenance phase post pulmonary rehabilitation
Primary Outcome Measure Information:
Title
6MWD
Time Frame
6 months
Secondary Outcome Measure Information:
Title
disease-specific quality of life (CRQ)
Time Frame
6 months
Title
exercise compliance
Time Frame
6 months
Title
exercise self-efficacy
Time Frame
6 months
Title
subject satisfaction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Hernandez, MDCM, FRCPC
Organizational Affiliation
Queen Elizabeth II Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Cobequid Community Health Centre
City
Lower Sackville
State/Province
Nova Scotia
ZIP/Postal Code
B4C 0A2
Country
Canada
12. IPD Sharing Statement
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Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
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