Pulmonary Disease, Chronic ObstructiveNCT02113748
Downhill Walking Training in COPD
A study testing Downhill walking training and Conventional walking training in people with Pulmonary Disease, Chronic Obstructive, run by KU Leuven at 1 site in Belgium.
Trial summary
This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Downhill walking training and Conventional walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Apr 2015
- 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 with a primary diagnosis of COPD according to internationally accepted guidelines
- Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)
Who cannot join
- Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities
- Absence of exacerbations in the previous month before entering the present study
- Patients included on the waiting list for lung transplantation
Trial locations and contacts
1 site in 1 country.
Thierry Troosters, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Vl-Brabant, 3000
Thierry Troosters, PhD, Thierry.Troosters@kuleuven.be
Carlos Augusto Camillo, MSc
About this study
Official title: Downhill Walking to Enhance Training Effects in Patients With COPD
This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD.
Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Downhill walking training, Conventional walking training
- Keywords
- Pulmonary disease, chronic obstructive, Downhill walking, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Downhill walking trainingOther
Walk on a treadmill with a negative inclination.
Conventional walking trainingOther
Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations
| Study group | Role | What they receive |
|---|---|---|
| Downhill walking training | Experimental | Exercise training including treadmill walking with a negative inclination. Receives: Other: Downhill walking training |
| Conventional walking training | Active comparator | Exercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations. Receives: Other: Conventional walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in 6-minute walking distance
Measured: changes from baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Thierry Troosters, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113748
- Sponsor's protocol ID
- ML10278
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.
PubMed 32444407
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Downhill Walking to Enhance Training Effects in Patients With COPD
- ClinicalTrials.gov ID
- NCT02113748
- Acronym / sponsor ID
- ML10278
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary disease, chronic obstructive, Downhill walking, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 15 Apr 2014 (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.
This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD.
Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Downhill walking training | Experimental | Other: Downhill walking trainingExercise training including treadmill walking with a negative inclination. |
| Conventional walking training | Active comparator | Other: Conventional walking trainingExercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a primary diagnosis of COPD according to internationally accepted guidelines
- Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)
Key exclusion criteria (3 listed)
- Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities
- Absence of exacerbations in the previous month before entering the present study
- Patients included on the waiting list for lung transplantation
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 |
|---|---|---|
| Downhill walking trainingWalk on a treadmill with a negative inclination. | Other | Downhill walking training |
| Conventional walking trainingWalk on a treadmill without inclination. Possible to progress training intensity with positive inclinations | Other | Conventional walking training |
Primary outcome
changes in 6-minute walking distance
Time frame: changes from baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Derived from this study: PubMed 32444407Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.
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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.
Thierry Troosters, PhD contact
Thierry Troosters, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Downhill walking training and Conventional walking training in people with Pulmonary Disease, Chronic Obstructive, run by KU Leuven at 1 site in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2014. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Troosters, PhD (Thierry.Troosters@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in 6-minute walking distance (time frame: changes from baseline to Week 12). 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 NCT02113748, which also lists 1 linked publication.
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 Apr 2014.