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

  • STATUS
    Recruiting
  • End date
    Jan 17, 2025
  • participants needed
    154
  • sponsor
    KU Leuven
Updated on 17 March 2022

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.

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.

Details
Condition COPD Exacerbation
Treatment exercise training, PA coaching
Clinical Study IdentifierNCT05233137
SponsorKU Leuven
Last Modified on17 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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