COPDNCT01218282
Exercise Training in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Home exercise training and NO Exercise Training in people with COPD, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Home exercise training and NO Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Mar 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.
Who cannot join
- COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pulmonary respiratory unit- University Hospital
Ferrara, Ferrara, 44100
About this study
Official title: Different Methods of Home Exercise Training in COPD Patients
Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity.
This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.
- Conditions
- COPD
- Being tested
- Home exercise training, NO Exercise Training
- Keywords
- COPD, home exercise training
- 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.
Home exercise trainingBehavioural
Also called Pulmonary Rehabilitation
20-30 min/day for at least 4 days/week
NO Exercise TrainingBehavioural
Also called No intervention
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Training Group A1 | Experimental | Patients assigned to this arm maintain the prescribed walking speed during the training with a metronome Receives: Behavioral: Home exercise training |
| Home Exercise Training Group A2 | Experimental | Patients assigned to this arm cover a fixed distance in a given period of time. Receives: Behavioral: Home exercise training |
| Control | No intervention | Not described Receives: Behavioral: NO Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Investigators
- Annalisa Cogo, MD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218282
- Sponsor's protocol ID
- ExTCOPD01
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2010
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods of Home Exercise Training in COPD Patients
- ClinicalTrials.gov ID
- NCT01218282
- Acronym / sponsor ID
- ExTCOPD01
- Conditions
- COPD
- Keywords
- COPD, home exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Oct 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.
Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity.
This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Training Group A1 | Experimental | Behavioral: Home exercise trainingPatients assigned to this arm maintain the prescribed walking speed during the training with a metronome |
| Home Exercise Training Group A2 | Experimental | Behavioral: Home exercise trainingPatients assigned to this arm cover a fixed distance in a given period of time. |
| Control | No intervention | Behavioral: NO Exercise Training |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.
Key exclusion criteria (1 listed)
- COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.
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 |
|---|---|---|
| Home exercise trainingAlso: Pulmonary Rehabilitation20-30 min/day for at least 4 days/week | Behavioural | Home Exercise Training Group A1, Home Exercise Training Group A2 |
| NO Exercise TrainingAlso: No interventionNo intervention | Behavioural | Control |
Primary outcome
Exercise Capacity
Time frame: 1 year
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 27 Oct 2010.
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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.
Annalisa Cogo, MD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise training and NO Exercise Training in people with COPD, run by Università degli Studi di Ferrara at 1 site in Italy.
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 27 Oct 2010. 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 Italy. 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?
Exercise Capacity (time frame: 1 year). 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 27 Oct 2010.