COPDNCT00169897
Pulmonary Rehabilitation at Home Versus at the Gymnasium
A study testing Pulmonary rehabilitation (teaching and exercise) in people with COPD, run by Laval University at 10 sites in Canada.
Trial summary
Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number… Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary rehabilitation (teaching and exercise)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 10 sitesCanada
- Study dates
- Jan 2004to Jan 2007
- Phase
- Interventional
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to ambulate. Defined as a 6MWD greater than 110 meters.
- Subject is diagnosed with COPD.
- 40 years-old and older
- Currently or previously smoking with a smoking history of at least 10 pack-years.
- Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70%.
- No previous diagnosis of asthma, left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction), terminal disease, dementia or uncontrolled psychiatric illness.
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- Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long term care facility.
- Subject understands and is able to read and write French or English.
- MRC dyspnea scale of at least 2.
Who cannot join
- The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
CRMSBC/Centre Hospitalier Baie-des-Chaleurs
Bonaventure, Quebec, G0C 1YO
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
Jewish Rehabilitation Hospital
Laval, Quebec, H7V 1R2
Hopital Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1
Montreal Chest Institute
Montreal, Quebec, H2X 2P4
Hopital Sacre-Coeur
Montreal, Quebec, H4J 1C5
Mount Sinai Hospital
Montreal, Quebec, H4W 1S7
CHA Enfant Jesus
Québec, Quebec, G1J 1Z4
Hopital Laval
Sainte-Foy, Quebec, G1V 4G5
St-Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial
Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation.
Read the detailed description
This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
- Conditions
- COPD
- Being tested
- Pulmonary rehabilitation (teaching and exercise)
- Keywords
- COPD, Exercise, Self-management, Rehabilitation, Quality of life, Health economy, Cost effectiveness, Health care utilization
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation (teaching and exercise)Behavioural
After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based | Experimental | This group has to go at the hospital 3 times per week to do the exercise program. Receives: Behavioral: Pulmonary rehabilitation (teaching and exercise) |
| Home-Based | Active comparator | The group had to do the exercise program at home with indirect supervision (Polar watches and a phone call per week). Receives: Behavioral: Pulmonary rehabilitation (teaching and exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
Measured: The data collection was terminated in January 2007 and publication was done December 2008
Secondary outcomes (3)
2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.
Measured: The data collection was terminated in January 2007.
3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.
Measured: The data collection was terminated in January 2007.
4 Intervention cost.
Measured: The data collection was terminated in January 2007.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Investigators
- Francois Maltais, MD, Principal investigator, Laval University - Hopital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169897
- Sponsor's protocol ID
- ISRCTN32824512
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PubMed 33511633Mak S, Bourbeau J, Mayo NE, Wood-Dauphinee S, Soicher JE. Psychometric Testing of the CHAMPS Questionnaire in French Canadians with COPD. Can Respir J. 2019 Sep 17;2019:2185207. doi: 10.1155/2019/2185207. eCollection 2019.
PubMed 31636770
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Versus a Hospital-based Outpatient Pulmonary Rehabilitation Program in Patients With COPD: a Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT00169897
- Acronym / sponsor ID
- ISRCTN32824512
- Conditions
- COPD
- Keywords
- COPD, Exercise, Self-management, Rehabilitation, Quality of life, Health economy, Cost effectiveness, Health care utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec
- Study start
- Jan 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation.
Detailed description
This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-based | Experimental | Behavioral: Pulmonary rehabilitation (teaching and exercise)This group has to go at the hospital 3 times per week to do the exercise program. |
| Home-Based | Active comparator | Behavioral: Pulmonary rehabilitation (teaching and exercise)The group had to do the exercise program at home with indirect supervision (Polar watches and a phone call per week). |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is able to ambulate. Defined as a 6MWD greater than 110 meters.
- Subject is diagnosed with COPD.
- 40 years-old and older
- Currently or previously smoking with a smoking history of at least 10 pack-years.
- Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70%.
Key exclusion criteria (1 listed)
- The need for supplemental oxygen at rest or during exercise will not be an exclusion criterion.
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 |
|---|---|---|
| Pulmonary rehabilitation (teaching and exercise)After a 4-week education program, patients took part to home-based rehabilitation or outpatient hospital-based rehabilitation for 8 weeks. Patients were subsequently followed for 40 weeks to complete the one-year study. | Behavioural | Home-Based, Hospital-based |
Primary outcome
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable.
Time frame: The data collection was terminated in January 2007 and publication was done December 2008
Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.
3 secondary outcomes
2-CRQ total score and specific domains, exercise tolerance (6MWD and submaximal exercise test) and ADL at 4 months.
Time frame: The data collection was terminated in January 2007.
3-Health service utilization (physician and emergency department visits, hospitalizations) over the 1-year study period.
Time frame: The data collection was terminated in January 2007.
4 Intervention cost.
Time frame: The data collection was terminated in January 2007.
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 15 Nov 2010.
- Derived from this study: PubMed 33511633Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Derived from this study: PubMed 31636770Mak S, Bourbeau J, Mayo NE, Wood-Dauphinee S, Soicher JE. Psychometric Testing of the CHAMPS Questionnaire in French Canadians with COPD. Can Respir J. 2019 Sep 17;2019:2185207. doi: 10.1155/2019/2185207. eCollection 2019.
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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.
Francois Maltais, MD principal investigator
Laval University - Hopital Laval
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation (teaching and exercise) in people with COPD, run by Laval University at 10 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 9 inclusion and 1 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 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
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?
The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. (time frame: The data collection was terminated in January 2007 and publication was done December 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169897, which also lists 2 linked publications.
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 15 Nov 2010.