Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline

NCT ID: NCT05233137

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2025-01-14

Brief 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. 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:

1. Investigate whether an 8 week exercise training program provided in primary or community care enhances lower limb muscle strength in patients following an AECOPD;

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PA coaching and exercise training

Patients in this group will receive physical activity telecoaching as well as an exercise training program provided by a physiotherapist in primary care

Group Type: EXPERIMENTAL

PA coaching

Intervention Type: BEHAVIORAL

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 training

Intervention Type: OTHER

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.

PA coaching

Patients in this group will receive physical activity telecoaching

Group Type: ACTIVE_COMPARATOR

PA coaching

Intervention Type: BEHAVIORAL

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.

Interventions

PA coaching

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.

Intervention Type: BEHAVIORAL

Exercise training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Thierry Troosters

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Derom

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Wim Janssens

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Heleen Demeyer

Role: PRINCIPAL_INVESTIGATOR

UGent

Thierry Troosters

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Marieke Wuyts

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Fien Hermans

Role: PRINCIPAL_INVESTIGATOR

U Gent

Locations

UZ Gent

Ghent, , Belgium

University Hospitals Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 38295552 (View on PubMed)

Other Identifiers

S65813

Identifier Type: -

Identifier Source: org_study_id