COPDNCT00781183
Does Pulmonary Rehabilitation Change Self-Selected And Maximum Sustainable Walking Speed In Patients With Lung Disease?
A study testing pulmonary rehabilitation in people with COPD and Chronic Lung Disease, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Exercise training has been shown to reduce breathlessness and improve the exercise tolerance of people with lung disease. However, the effect of exercise training on the walking speed selected by these people during day-to-day life is unknown. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Chronic Lung Disease
- What is being tested?
- pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients referred to pulmonary rehabilitation with symptomatic chronic lung disease
Who cannot join
- Co-morbid conditions that adversely affect exercise capacity or participation in a pulmonary rehabilitation program; inability to provide written informed consent; weaning doses of oral corticosteroids or methylxanthines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Pulmonary Rehabilitation Change The Self-Selected And Maximum Sustainable Walking Speed In Patients With Symptomatic Lung Disease?
Exercise training has been shown to reduce breathlessness and improve the exercise tolerance of people with lung disease. However, the effect of exercise training on the walking speed selected by these people during day-to-day life is unknown. Furthermore,the investigator do not know if exercise training changes the maximum speed that these people can walk at for a long period of time. This study will examine the relationship between walking speed and walking endurance before and following exercise training in people with lung disease and contribute importantly to our understanding of how patients choose to walk in relation to their capabilities.
Read the detailed description
Rationale: Pulmonary rehabilitation (PR) is considered a standard of care for patients with symptomatic lung disease. It has achieved strong evidence for reducing symptoms and improving exercise tolerance. Walking is the most common form of physical activity and most individuals need to walk in the course of their daily activities. Chosen walking speed is a good indicator of the debilitating effects of disease and improvement in usual walk speed has been associated with a substantial reduction in mortality in elderly subjects. Therefore, it is important for clinicians to understand how patients choose to walk in relation to their capabilities as well as to know how this relationship changes with PR.
The main purpose of this study is to examine the relationship between walking speed and walking endurance before and after PR.
Primary aim: to estimate the maximum walking speed that can be sustained for > 24 min (i.e. maximum sustainable walking speed; MSWS) from the relationship between walking speed and walking time in patients with symptomatic lung disease.
Secondary aims: (i) to determine if chosen speed during the endurance walk test is different from the MSWS, (ii) to determine if MSWS and speed chosen for the endurance walk test changes in response to PR and, (iii) to measure the repeatability of endurance walk time (EWT), defined as the duration a patient can walk at a self-selected pace before that first need to stop and rest.
Significance: Walking is the most common form of physical activity. Chosen walking speed and the capacity to endure walking at different speeds can help quantify disability. Also, studies that examine the effect of PR on survival are not available. However, indirect evidence suggests that PR improves many of the risk factors associated with mortality in patients with COPD. This study will examine the effect of PR on the usual walking speed selected by individuals with symptomatic lung disease, which has been demonstrated to be a predictor of mortality in elderly individuals. Therefore, our study may contribute to the indirect evidence for the effects of PR on survival.
- Conditions
- COPD, Chronic Lung Disease
- Being tested
- pulmonary rehabilitation
- Keywords
- COPD, rehabilitation, walking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
6-weeks of in-patient pulmonary rehabilitation or 12-weeks of out-patient pulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| pulmonary rehabilitation | Experimental | patients that are enrolled in pulmonary rehabilitation Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance walk time (EWT) defined as the time a patient can walk at a self-selected speed until they first need to stop and rest
Measured: Pre and post pulmonary rehabilitation
The maximum sustainable walk speed (MSWS) defined as the maximum speed that a patient walk for at for > 24 minutes
Measured: Pre and post pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger S Goldstein, MD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781183
- Sponsor's protocol ID
- D6255L00002
- Status last verified
- Dec 2012
- First submitted
- 27 Oct 2008
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dolmage TE, Evans RA, Hill K, Blouin M, Brooks D, Goldstein RS. The effect of pulmonary rehabilitation on critical walk speed in patients with COPD: a comparison with self-paced walks. Chest. 2012 Feb;141(2):413-419. doi: 10.1378/chest.11-1059. Epub 2011 Jul 21.
PubMed 21778262Evans RA, Hill K, Dolmage TE, Blouin M, O'Hoski S, Brooks D, Goldstein RS. Properties of self-paced walking in chronic respiratory disease: a patient goal-oriented assessment. Chest. 2011 Sep;140(3):737-743. doi: 10.1378/chest.10-3104. Epub 2011 Mar 10.
PubMed 21393393
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pulmonary Rehabilitation Change The Self-Selected And Maximum Sustainable Walking Speed In Patients With Symptomatic Lung Disease?
- ClinicalTrials.gov ID
- NCT00781183
- Acronym / sponsor ID
- D6255L00002
- Conditions
- COPD, Chronic Lung Disease
- Keywords
- COPD, rehabilitation, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Oct 2008 (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.
Exercise training has been shown to reduce breathlessness and improve the exercise tolerance of people with lung disease. However, the effect of exercise training on the walking speed selected by these people during day-to-day life is unknown. Furthermore,the investigator do not know if exercise training changes the maximum speed that these people can walk at for a long period of time. This study will examine the relationship between walking speed and walking endurance before and following exercise training in people with lung disease and contribute importantly to our understanding of how patients choose to walk in relation to their capabilities.
Detailed description
Rationale: Pulmonary rehabilitation (PR) is considered a standard of care for patients with symptomatic lung disease. It has achieved strong evidence for reducing symptoms and improving exercise tolerance. Walking is the most common form of physical activity and most individuals need to walk in the course of their daily activities. Chosen walking speed is a good indicator of the debilitating effects of disease and improvement in usual walk speed has been associated with a substantial reduction in mortality in elderly subjects. Therefore, it is important for clinicians to understand how patients choose to walk in relation to their capabilities as well as to know how this relationship changes with PR.
The main purpose of this study is to examine the relationship between walking speed and walking endurance before and after PR.
Primary aim: to estimate the maximum walking speed that can be sustained for > 24 min (i.e. maximum sustainable walking speed; MSWS) from the relationship between walking speed and walking time in patients with symptomatic lung disease.
Secondary aims: (i) to determine if chosen speed during the endurance walk test is different from the MSWS, (ii) to determine if MSWS and speed chosen for the endurance walk test changes in response to PR and, (iii) to measure the repeatability of endurance walk time (EWT), defined as the duration a patient can walk at a self-selected pace before that first need to stop and rest.
Significance: Walking is the most common form of physical activity. Chosen walking speed and the capacity to endure walking at different speeds can help quantify disability. Also, studies that examine the effect of PR on survival are not available. However, indirect evidence suggests that PR improves many of the risk factors associated with mortality in patients with COPD. This study will examine the effect of PR on the usual walking speed selected by individuals with symptomatic lung disease, which has been demonstrated to be a predictor of mortality in elderly individuals. Therefore, our study may contribute to the indirect evidence for the effects of PR on survival.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary rehabilitation | Experimental | Other: pulmonary rehabilitationpatients that are enrolled in pulmonary rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to pulmonary rehabilitation with symptomatic chronic lung disease
Key exclusion criteria (1 listed)
- Co-morbid conditions that adversely affect exercise capacity or participation in a pulmonary rehabilitation program; inability to provide written informed consent; weaning doses of oral corticosteroids or methylxanthines
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 rehabilitation6-weeks of in-patient pulmonary rehabilitation or 12-weeks of out-patient pulmonary rehabilitation | Other | pulmonary rehabilitation |
Primary outcome
Endurance walk time (EWT) defined as the time a patient can walk at a self-selected speed until they first need to stop and rest
Time frame: Pre and post pulmonary rehabilitation
The maximum sustainable walk speed (MSWS) defined as the maximum speed that a patient walk for at for > 24 minutes
Time frame: Pre and post pulmonary rehabilitation
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 21 Dec 2012.
- Derived from this study: PubMed 21778262Dolmage TE, Evans RA, Hill K, Blouin M, Brooks D, Goldstein RS. The effect of pulmonary rehabilitation on critical walk speed in patients with COPD: a comparison with self-paced walks. Chest. 2012 Feb;141(2):413-419. doi: 10.1378/chest.11-1059. Epub 2011 Jul 21.
- Derived from this study: PubMed 21393393Evans RA, Hill K, Dolmage TE, Blouin M, O'Hoski S, Brooks D, Goldstein RS. Properties of self-paced walking in chronic respiratory disease: a patient goal-oriented assessment. Chest. 2011 Sep;140(3):737-743. doi: 10.1378/chest.10-3104. Epub 2011 Mar 10.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Roger S Goldstein, MD principal investigator
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation in people with COPD and Chronic Lung Disease, run by West Park Healthcare Centre at 1 site 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 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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Endurance walk time (EWT) defined as the time a patient can walk at a self-selected speed until they first need to stop and rest (time frame: Pre and post pulmonary rehabilitation). The study lists 2 primary outcomes in all. 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 NCT00781183, 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 21 Dec 2012.