Lung DiseasesPhase 3NCT01235481
Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.
A Phase 3 study testing Exercise DVD in people with Lung Diseases, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Exercise DVD
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2010to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any participant enrolled in pulmonary rehabilitation program
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Cobequid Community Health Centre
Lower Sackville, Nova Scotia, B4C 0A2
About this study
Official title: 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.
- Conditions
- Lung Diseases
- Being tested
- Exercise DVD, Usual Care
- Keywords
- pulmonary rehabilitation, exercise therapy, chronic lung disease, self-efficacy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise DVDDevice
Also called Home exercise training
Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation
Usual CareBehavioural
Also called No exercise DVD provided
Usual care during maintenance phase post pulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Exercise DVD | Experimental | Exercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training Receives: Device: Exercise DVD; Behavioral: Usual Care |
| Usual Care | Other | Participants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD
Measured: 6 months
Secondary outcomes (4)
disease-specific quality of life (CRQ)
Measured: 6 months
exercise compliance
Measured: 6 months
exercise self-efficacy
Measured: 6 months
subject satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Health, Canada
- Responsible party
- Principal investigator, Paul Hernandez, Nova Scotia Health Authority
- Investigators
- Paul Hernandez, MDCM, FRCPC, Principal investigator, Queen Elizabeth II Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235481
- Sponsor's protocol ID
- CDHA-RS/2011-159
- Status last verified
- May 2015
- First submitted
- 4 Nov 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Exercise DVD for Maintenance After 12-week Outpatient Pulmonary Rehabilitation Program: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01235481
- Acronym / sponsor ID
- CDHA-RS/2011-159
- Conditions
- Lung Diseases
- Keywords
- pulmonary rehabilitation, exercise therapy, chronic lung disease, self-efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Capital Health, Canada
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise DVD | Experimental | Device: Exercise DVD, Behavioral: Usual CareExercise DVD to be used by participants 30-60 minutes, once daily to facilitate maintenance exercise training |
| Usual Care | Other | Behavioral: Usual CareParticipants advised to perform maintenance exercise training 30-60 minutes, once daily without benefit of exercise DVD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any participant enrolled in pulmonary rehabilitation program
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise DVDAlso: Home exercise trainingExercise DVD added to usual care during maintenance phase of pulmonary rehabilitation | Device | Exercise DVD |
| Usual CareAlso: No exercise DVD providedUsual care during maintenance phase post pulmonary rehabilitation | Behavioural | Exercise DVD, Usual Care |
Primary outcome
6MWD
Time frame: 6 months
4 secondary outcomes
disease-specific quality of life (CRQ)
Time frame: 6 months
exercise compliance
Time frame: 6 months
exercise self-efficacy
Time frame: 6 months
subject satisfaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Hernandez, MDCM, FRCPC principal investigator
Queen Elizabeth II Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise DVD in people with Lung Diseases, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.