COPD ExacerbationNCT05233137
Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline
A study testing PA coaching and Exercise training in people with COPD Exacerbation, run by KU Leuven at 2 sites in Belgium.
Trial summary
Patients with COPD lose muscle strength during acute exacerbations of COPD (AECOPD) which interferes improving the recovery of physical activity (PA) after an AECOPD. Resistance training can reverse this process. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- PA coaching and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesBelgium
- Study dates
- 8 Feb 2022to 14 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD
- Smoking history (> or = 10 pack years)
- Experiencing a moderate (i.e. treated with short acting bronchodilatators plus antibiotics and/or oral corticosteroids or emergency room visit and reported impact on activities of daily living) exacerbation
Who cannot join
- More than 21 days after stopping the treatment for the AECOPD
- Presence of orthopaedic problems or other contra-indications not allowing to perform PA
- Participation in or planned to start a multidisciplinary pulmonary rehabilitation program
- Already participating in an intensive training program in the first 12 weeks in primary care with the aim of enhancing physical performance (maintenance programs are allowed)
- Unable to learn to work with a smartphone and Fitbit, as judged by the investigator
- Underwent major lung surgery (e.g. lung transplantation) or active on the lung transplantation list
- Lung volume reduction within 6 months before inclusion
- Having the current diagnosis of lung cancer or receiving active treatment for oncology
Trial locations and contacts
2 sites in 1 country.
About this study
Patients with COPD lose muscle strength during acute exacerbations of COPD (AECOPD) which interferes improving the recovery of physical activity (PA) after an AECOPD. Resistance training can reverse this process. An exercise training program with the focus on resistance training is essential in minimizing the long-term effects of AECOPD as it may help to accelerate the gain in PA in the weeks after an acute event. Therefore, it is important that such programs are embedded at the right moment (i.e. immediately after an AECOPD) and in a setting accessible to the patient (i.e. primary care). The efficacy and effectiveness of implementing such training programs will be assessed in the present study.
Read the detailed description
The present study aims to:
- Investigate whether an 8 week exercise training program provided in primary or community care enhances lower limb muscle strength in patients following an AECOPD;
- Investigate whether such programs assist patients after an AECOPD to re-engage with a coaching intervention geared to long-term PA maintenance or improvement.
The secondary aim is to investigate how (repeated) AECOPD contribute to structural alterations in the skeletal muscle and how an exercise training program and PA can influence the deterioration in muscle fiber morphology and signals related to muscle atrophy.
Patients that experience a moderate or severe AECOPD will be recruited in the present multicentre randomised controlled trial (RCT).
Patients in this study will have at least 3 clinical visits:
- Post AECOPD treatment: screening and randomisation visit (V1)
- 8 weeks after randomisation (V2a and V2b*)
- 52 weeks after randomisation (V3a and V3b*)
- If patients agree to have a muscle biopsy taken, a V2b and V3b will be added, so this does not interfere with other measurements. These visits will take place 1-2 weeks after V2a and V3a, respectively.
After the screening and randomisation visit (V1), the patient will be randomised in either the intervention group (PA coaching and exercise training) or the control group (PA coaching).
Patients in the intervention group will receive a first physiotherapy session during this first visit provided by the trained researchers (with a degree in physiotherapy) to get acquainted with the exercises. Information about the PA coaching will be given to all the patients. The intervention will be started after this visit and is provided by a physiotherapist in primary or community care.
- Conditions
- COPD Exacerbation
- Being tested
- PA coaching, Exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA coachingBehavioural
PA coaching: Patients receive a step counter together with a coaching application (m-PAC, AppsOnly, KU Leuven) installed on a smartphone. The step counter and coaching application are connected via Bluetooth. The coaching application has the goal of PA promotion as well as detecting any new AECOPD.
Exercise trainingOther
Each session will include at least the following components:
- Resistance training of the lower limbs: Exercises for 6 muscle groups using minimal (e.g. ankle weights or elastic resistance bands) or no (body weight) equipment are foreseen. Each exercise will be performed in 3 series of 8 repetitions.
- Functional training: Sit to stand exercise and stair climbing. During the first 2 weeks of the exercise training program, at least 3 strength exercises and 1 functional exercise will be performed each session.
Starting from the 3rd week of the exercise training program, whole body exercise training (interval training for walking, cycling, stair climbing and high knees) will be added. From this moment on, at least 1-2 whole body exercises and 2-3 strength and functional exercises will be performed during each physiotherapy session. By doing this, each session will consist of a minimum of 4 exercises in total.
| Study group | Role | What they receive |
|---|---|---|
| PA coaching and exercise training | Experimental | Patients in this group will receive physical activity telecoaching as well as an exercise training program provided by a physiotherapist in primary care Receives: Behavioral: PA coaching; Other: Exercise training |
| PA coaching | Active comparator | Patients in this group will receive physical activity telecoaching Receives: Behavioral: PA coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily number of steps at 52 weeks
Change in daily mean step count 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Measured: 52 weeks
Isometric quadriceps force
Isometric quadriceps strength of the right leg will be measured using the strain gauge device (Sauter Controls NV, Zellik, Belgium) with the hip and knee in 90° flexion. Four repetitions will be performed using standardized encouragement with the first attempt not being maximal and not counting as a possible best result. The best of the last three measurements will be used.
Measured: 8 weeks
Secondary outcomes (27)
Functional exercise capacity
Change in six-minutes walk distance between baseline and 52 weeks post randomization in the intervention group as compared to the control group. The six-minutes walk test will be performed with standardized encouragement to assess patients' functional exercise capacity. The best of two measurements will be used.
Measured: 8 and 52 weeks
Isometric quadriceps force
Isometric quadriceps strength of the right leg will be measured using the strain gauge device (Sauter Controls NV, Zellik, Belgium) with the hip and knee in 90° flexion. Four repetitions will be performed using standardized encouragement with the first attempt not being maximal and not counting as a possible best result. The best of the last three measurements will be used.
Measured: 52 weeks
Functional performance
This will be evaluated using the SPPB. This test assesses lower extremity function and mobility. It consists of 3 subtests that are scored and points are added up:
- 4-meter gait speed: To evaluate the patient's functional gait speed. The test is repeated twice. The best time of the 2 attempts is used for the rating. Cut-off: <0.3 m/s or ≥0.3 m/s.
- 5 times sit to stand: This test quantifies the functional lower extremity strength. In this test, patients are asked to complete 5 cycles sit-to-stand as fast as possible from a 45 cm height chair. The participant may practice 1 repetition prior commencing the test. The time needed to perform 5 repetitions is noted. Cut-offs: ≤11.19 seconds (4 points); A higher score indicates a better functional performance.
Measured: 8 weeks and 52 weeks
Health related quality of life
Change in health related quality of life wil be measured by the Chronic Respiratory Disease Questionnaire (CRDQ-SAS) (dyspnea domain):
This disease specific questionnaire measures both physical and emotional aspects of the chronic respiratory disease. The questionnaire contains 20 items, spread over 4 domains (dyspnea, fatigue, emotional function and mastery). The MCID is reflected by a change in score of 0.5 on a 7-point scale for each of the CRDQ domains (28). Only the dyspnea domain will be used for this study. The self-administered standardized (CRDQ-SAS) version will be used. A higher score indicates a higher health related quality of life.
Measured: 8 weeks and 52 weeks
Health status
Change in health status will be measured using the COPD Assessment Test (CAT):
This validated 8-item questionnaire assesses the impact of the disease on a patient's health status. Scores range from 0 (good health status) to 40 (worse health status). The minimal clinical important difference (MCID) is a change of 2 points (19).
Measured: 8 weeks and 52 weeks
Patient experience of PA
Change in patient experience of physical activity will be measured using the Patient Reported Outcome (PRO) -active (C-PPAC) questionnaire: a simple, valid and reliable 12-item questionnaire assessing PA from a patient's perspective reflecting on the past 7 days. The questionnaire investigates the experienced amount of and difficulty of PA as perceived by the patient. The 2 domain scores as well as the total score will be retrieved as outcomes. The clinical visit version will be used. A paper version of the questionnaire will be given along with the monitor. Subscores and total score are from 0 to 100, with higher score meaning less problems with daily life activities as reported by the patient
Measured: 8 weeks and 52 weeks
Change in high-density lipoprotein (HDL)
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Change in low-density lipoprotein (LDL)
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Change in total cholesterol
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Change in triglycerides
By taking a fasting blood sample of the patient and triglycerides) and blood pressure
Measured: 8 weeks and 52 weeks
Change in blood pressure
By taking the systolic and diastolic blood pressure of the patient at rest
Measured: 8 weeks and 52 weeks
Change in weight
By taking the weight of the patient
Measured: 8 weeks and 52 weeks
Change in waist and hip circumference
The waist and hip circumference will be measured and risk factors fasting blood sample (glucose level, insulin Hba1c)
Measured: 8 weeks and 52 weeks
Change in insulin
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Change in glucose level
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Change in Hba1c
By taking a fasting blood sample of the patient
Measured: 8 weeks and 52 weeks
Day to day Physical Activity
Change in day to day data of PA will be assessed by a wearable. The patient receives a step counter (Fitbit) that can be worn on the wrist. The device provides direct feedback, expressed as the number of steps taken per day. The patient is asked to wear the step counter every day during the intervention and is invited to frequently verify the number of steps per day against the agreed goals.
Measured: 52 weeks
Number of AECOPD
Number of AECOPD following the index AECOPD
Measured: 52 weeks
Change in fiber type proportion of the m. vastus lateralis of the quadriceps muscle
By analysing muscle microbiopsies of the quadriceps muscle immunostaining of the myosin heavy chain, only for patients giving their specific consent.
Measured: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in cross-sectional area of the m. vastus lateralis of the quadriceps muscle
By analysing muscle microbiopsies of the quadriceps muscle immunostaining of the myosin heavy chain, only for patients giving their specific consent.
Measured: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in capillarisation of the m. vastus lateralis of the quadriceps muscle
By analysing muscle microbiopsies of the quadriceps muscle, only for patients giving their specific consent.
Measured: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in the amount of satellite cells of the m. vastus lateralis of the quadriceps muscle
By analysing muscle microbiopsies with Pax7 immunostaining of the quadriceps muscle, only for patients giving their specific consent.
Measured: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in gene expression of the m. vastus lateralis of the quadriceps muscle
By analysing muscle microbiopsies with RT2 profiler PCR array skeletal muscle, Qiagen of the quadriceps muscle, only for patients giving their specific consent.
Measured: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Minutes per day spent in at least moderate intense activities
Change in minutes per day spent in at least moderate intense activities between baseline, 8 weeks and 52 weeks months post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Measured: 8 weeks and 52 weeks
Mean walking time per day
Change in mean daily walking time between baseline, 8 weeks and 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Measured: 8 weeks and 52 weeks
Mean sedentary time per day
Change in mean sedentary time between baseline, 8 weeks and 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Measured: 8 weeks and 52 weeks
Daily number of steps at 8 weeks
Change in daily mean step count between baseline and 8 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start8 Feb 2022
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
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 COPD ExacerbationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Thierry Troosters, KU Leuven
- Investigators
- Eric Derom, Principal investigator, UZ GentWim Janssens, Principal investigator, UZ LeuvenHeleen Demeyer, Principal investigator, UGentThierry Troosters, Principal investigator, KU LeuvenMarieke Wuyts, Principal investigator, KU LeuvenFien Hermans, Principal investigator, U Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233137
- Sponsor's protocol ID
- S65813
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2022
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregated data can be shared upon request.
Publications
Wuyts M, Hermans F, Breuls S, Everaerts S, Derom E, Janssens W, Demeyer H, Troosters T. Development and feasibility of an exercise training program in primary care for patients with COPD experiencing an acute exacerbation. Physiotherapy. 2024 Jun;123:81-90. doi: 10.1016/j.physio.2023.09.003. Epub 2023 Oct 5.
PubMed 38295552
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline
- ClinicalTrials.gov ID
- NCT05233137
- Acronym / sponsor ID
- S65813
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 10 Feb 2022 (actual)
- 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.
Patients with COPD lose muscle strength during acute exacerbations of COPD (AECOPD) which interferes improving the recovery of physical activity (PA) after an AECOPD. Resistance training can reverse this process. An exercise training program with the focus on resistance training is essential in minimizing the long-term effects of AECOPD as it may help to accelerate the gain in PA in the weeks after an acute event. Therefore, it is important that such programs are embedded at the right moment (i.e. immediately after an AECOPD) and in a setting accessible to the patient (i.e. primary care). The efficacy and effectiveness of implementing such training programs will be assessed in the present study.
Detailed description
The present study aims to:
- Investigate whether an 8 week exercise training program provided in primary or community care enhances lower limb muscle strength in patients following an AECOPD;
- Investigate whether such programs assist patients after an AECOPD to re-engage with a coaching intervention geared to long-term PA maintenance or improvement.
The secondary aim is to investigate how (repeated) AECOPD contribute to structural alterations in the skeletal muscle and how an exercise training program and PA can influence the deterioration in muscle fiber morphology and signals related to muscle atrophy.
Patients that experience a moderate or severe AECOPD will be recruited in the present multicentre randomised controlled trial (RCT).
Patients in this study will have at least 3 clinical visits:
- Post AECOPD treatment: screening and randomisation visit (V1)
- 8 weeks after randomisation (V2a and V2b*)
- 52 weeks after randomisation (V3a and V3b*)
- If patients agree to have a muscle biopsy taken, a V2b and V3b will be added, so this does not interfere with other measurements. These visits will take place 1-2 weeks after V2a and V3a, respectively.
After the screening and randomisation visit (V1), the patient will be randomised in either the intervention group (PA coaching and exercise training) or the control group (PA coaching).
Patients in the intervention group will receive a first physiotherapy session during this first visit provided by the trained researchers (with a degree in physiotherapy) to get acquainted with the exercises. Information about the PA coaching will be given to all the patients. The intervention will be started after this visit and is provided by a physiotherapist in primary or community care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| PA coaching and exercise training | Experimental | Behavioral: PA coaching, Other: Exercise trainingPatients in this group will receive physical activity telecoaching as well as an exercise training program provided by a physiotherapist in primary care |
| PA coaching | Active comparator | Behavioral: PA coachingPatients in this group will receive physical activity telecoaching |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of COPD
- Smoking history (> or = 10 pack years)
- Experiencing a moderate (i.e. treated with short acting bronchodilatators plus antibiotics and/or oral corticosteroids or emergency room visit and reported impact on activities of daily living) exacerbation
Key exclusion criteria (8 listed)
- More than 21 days after stopping the treatment for the AECOPD
- Presence of orthopaedic problems or other contra-indications not allowing to perform PA
- Participation in or planned to start a multidisciplinary pulmonary rehabilitation program
- Already participating in an intensive training program in the first 12 weeks in primary care with the aim of enhancing physical performance (maintenance programs are allowed)
- Unable to learn to work with a smartphone and Fitbit, as judged by the investigator
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 |
|---|---|---|
| PA coachingPA coaching: Patients receive a step counter together with a coaching application (m-PAC, AppsOnly, KU Leuven) installed on a smartphone. The step counter and coaching application are connected via Bluetooth. The coaching application has the goal of PA promotion as well as detecting any new AECOPD. | Behavioural | PA coaching, PA coaching and exercise training |
| Exercise trainingEach session will include at least the following components: * Resistance training of the lower limbs: Exercises for 6 muscle groups using minimal (e.g. ankle weights or elastic resistance bands) or no (body weight) equipment are foreseen. Each exercise will be performed in 3 series of 8 repetitions. * Functional training: Sit to stand exercise and stair climbing. During the first 2 weeks of the exercise training program, at least 3 strength exercises and 1 functional exercise will be performed each session. Starting from the 3rd week of the exercise training program, whole body exercise training (interval training for walking, cycling, stair climbing and high knees) will be added. From this moment on, at least 1-2 whole body exercises and 2-3 strength and functional exercises will be performed during each physiotherapy session. By doing this, each session will consist of a minimum of 4 exercises in total. | Other | PA coaching and exercise training |
Primary outcome
Daily number of steps at 52 weeks
Time frame: 52 weeks
Change in daily mean step count 52 weeks post randomization in the intervention group as compared to the control group. Physical activity will be objectively measured for 1 week using a tri-axial accelerometer validated for use in patients with COPD. At least 4 valid weekdays (> 8 hours of wearing time during waking hours) is necessary to label the physical activity measurement as valid.
Isometric quadriceps force
Time frame: 8 weeks
Isometric quadriceps strength of the right leg will be measured using the strain gauge device (Sauter Controls NV, Zellik, Belgium) with the hip and knee in 90° flexion. Four repetitions will be performed using standardized encouragement with the first attempt not being maximal and not counting as a possible best result. The best of the last three measurements will be used.
27 secondary outcomes
Functional exercise capacity
Time frame: 8 and 52 weeks
Isometric quadriceps force
Time frame: 52 weeks
Functional performance
Time frame: 8 weeks and 52 weeks
Health related quality of life
Time frame: 8 weeks and 52 weeks
Health status
Time frame: 8 weeks and 52 weeks
Patient experience of PA
Time frame: 8 weeks and 52 weeks
Change in high-density lipoprotein (HDL)
Time frame: 8 weeks and 52 weeks
Change in low-density lipoprotein (LDL)
Time frame: 8 weeks and 52 weeks
Change in total cholesterol
Time frame: 8 weeks and 52 weeks
Change in triglycerides
Time frame: 8 weeks and 52 weeks
Change in blood pressure
Time frame: 8 weeks and 52 weeks
Change in weight
Time frame: 8 weeks and 52 weeks
Change in waist and hip circumference
Time frame: 8 weeks and 52 weeks
Change in insulin
Time frame: 8 weeks and 52 weeks
Change in glucose level
Time frame: 8 weeks and 52 weeks
Change in Hba1c
Time frame: 8 weeks and 52 weeks
Day to day Physical Activity
Time frame: 52 weeks
Number of AECOPD
Time frame: 52 weeks
Change in fiber type proportion of the m. vastus lateralis of the quadriceps muscle
Time frame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in cross-sectional area of the m. vastus lateralis of the quadriceps muscle
Time frame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in capillarisation of the m. vastus lateralis of the quadriceps muscle
Time frame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in the amount of satellite cells of the m. vastus lateralis of the quadriceps muscle
Time frame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Change in gene expression of the m. vastus lateralis of the quadriceps muscle
Time frame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
Minutes per day spent in at least moderate intense activities
Time frame: 8 weeks and 52 weeks
Mean walking time per day
Time frame: 8 weeks and 52 weeks
Mean sedentary time per day
Time frame: 8 weeks and 52 weeks
Daily number of steps at 8 weeks
Time frame: 8 weeks
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 19 Jun 2025.
- Background: PubMed 38295552Wuyts M, Hermans F, Breuls S, Everaerts S, Derom E, Janssens W, Demeyer H, Troosters T. Development and feasibility of an exercise training program in primary care for patients with COPD experiencing an acute exacerbation. Physiotherapy. 2024 Jun;123:81-90. doi: 10.1016/j.physio.2023.09.003. Epub 2023 Oct 5.
- Individual participant dataSharing planned: Undecided. Aggregated data can be shared upon request.
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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.
Eric Derom principal investigator
UZ Gent
Wim Janssens principal investigator
UZ Leuven
Heleen Demeyer principal investigator
UGent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA coaching and Exercise training in people with COPD Exacerbation, run by KU Leuven at 2 sites 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 3 inclusion and 8 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 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Daily number of steps at 52 weeks (time frame: 52 weeks). 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 NCT05233137, 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 19 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.