Pulmonary Disease, Chronic ObstructiveSTEPNCT02702791
Sustaining Training Effects Through Physical Activity
A study testing Telecoaching and pulmonary rehabilitation 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 the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Telecoaching and pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a primary diagnosis of COPD according to internationally accepted guidelines
- Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
- Current or previous smoking exposure of at least 10 pack years
- Ability to manage electronic devices (smartphone, step counter)
Who cannot join
- Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
- Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
- Patients on the waiting list for lung transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD
This randomized control trial will investigate whether the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.
After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Telecoaching, pulmonary rehabilitation
- Keywords
- Physical activity, Pulmonary rehabilitation, COPD
- 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.
TelecoachingBehavioural
Pedeometer based goals and telecoaching support
pulmonary rehabilitationOther
Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation. Receives: Behavioral: Telecoaching; Other: pulmonary rehabilitation |
| Usual care | Other | includes only general advices regarding physical activity. Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical activity (number of steps)
Measured: At three and six months of pulmonary rehabilitation and three and six months of follow up
Secondary outcomes (6)
Changes in physical activity (time spent in moderate activity)
Measured: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quadriceps force)
Measured: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)
Measured: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)
Measured: At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)
Measured: At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quality of life)
Measured: At three and six months of pulmonary rehabilitation and six months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2019
- Study completionOct 2019
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.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Thierry Troosters, PhD, Principal investigator, Katholiek Universiteit Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702791
- Sponsor's protocol ID
- s57963
- Acronym
- STEP
- Status last verified
- Oct 2019
- First submitted
- 12 Jan 2016
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Loeckx M, Rodrigues FM, Blondeel A, Everaerts S, Janssens W, Demeyer H, Troosters T. Sustaining training effects through physical activity coaching (STEP): a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 10;20(1):121. doi: 10.1186/s12966-023-01519-w.
PubMed 37814266
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity to Achieve Sustainable Benefits in Extrapulmonary Consequences of COPD
- ClinicalTrials.gov ID
- NCT02702791
- Acronym / sponsor ID
- STEP / s57963
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Physical activity, Pulmonary rehabilitation, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 9 Mar 2016 (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 the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.
After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Telecoaching, Other: pulmonary rehabilitationTelecoaching - feasible goal setting and feedback to enhance patient's motivation and commitment - in addition to pulmonary rehabilitation. |
| Usual care | Other | Other: pulmonary rehabilitationincludes only general advices regarding physical activity. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a primary diagnosis of COPD according to internationally accepted guidelines
- Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
- Current or previous smoking exposure of at least 10 pack years
- Ability to manage electronic devices (smartphone, step counter)
Key exclusion criteria (3 listed)
- Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
- Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
- Patients 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 |
|---|---|---|
| TelecoachingPedeometer based goals and telecoaching support | Behavioural | Intervention |
| pulmonary rehabilitationConventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months. | Other | Intervention, Usual care |
Primary outcome
Changes in physical activity (number of steps)
Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
6 secondary outcomes
Changes in physical activity (time spent in moderate activity)
Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quadriceps force)
Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Functional exercise capacity)
Time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up
Changes in pulmonary rehabilitation outcomes (Maximal exercise capacity)
Time frame: At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Endurance exercise capactity)
Time frame: At three and six months of pulmonary rehabilitation and six months of follow up
Changes in pulmonary rehabilitation outcomes (Quality of life)
Time frame: At three and six months of pulmonary rehabilitation and six months of follow up
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 24 Oct 2019.
- Derived from this study: PubMed 37814266Loeckx M, Rodrigues FM, Blondeel A, Everaerts S, Janssens W, Demeyer H, Troosters T. Sustaining training effects through physical activity coaching (STEP): a randomized controlled trial. Int J Behav Nutr Phys Act. 2023 Oct 10;20(1):121. doi: 10.1186/s12966-023-01519-w.
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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 principal investigator
Katholiek Universiteit 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 Telecoaching and pulmonary rehabilitation 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 4 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 24 Oct 2019. 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?
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?
Changes in physical activity (number of steps) (time frame: At three and six months of pulmonary rehabilitation and three and six months of follow up). 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 NCT02702791, 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 24 Oct 2019.