Clinical trial NCT05233137: Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline
Official title: Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation - Flanders (FWO: Fonds Wetenschappelijk Onderzoek)
First posted: 2022-02-10
Enrollment: 154
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Daily number of steps at 52 weeks
timeFrame: 52 weeks
measure: Isometric quadriceps force
timeFrame: 8 weeks
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: 8 and 52 weeks
measure: Isometric quadriceps force
timeFrame: 52 weeks
measure: Functional performance
timeFrame: 8 weeks and 52 weeks
measure: Health related quality of life
timeFrame: 8 weeks and 52 weeks
measure: Health status
timeFrame: 8 weeks and 52 weeks
measure: Patient experience of PA
timeFrame: 8 weeks and 52 weeks
measure: Change in high-density lipoprotein (HDL)
timeFrame: 8 weeks and 52 weeks
measure: Change in low-density lipoprotein (LDL)
timeFrame: 8 weeks and 52 weeks
measure: Change in total cholesterol
timeFrame: 8 weeks and 52 weeks
measure: Change in triglycerides
timeFrame: 8 weeks and 52 weeks
measure: Change in blood pressure
timeFrame: 8 weeks and 52 weeks
measure: Change in weight
timeFrame: 8 weeks and 52 weeks
measure: Change in waist and hip circumference
timeFrame: 8 weeks and 52 weeks
measure: Change in insulin
timeFrame: 8 weeks and 52 weeks
measure: Change in glucose level
timeFrame: 8 weeks and 52 weeks
measure: Change in Hba1c
timeFrame: 8 weeks and 52 weeks
measure: Day to day Physical Activity
timeFrame: 52 weeks
measure: Number of AECOPD
timeFrame: 52 weeks
measure: Change in fiber type proportion of the m. vastus lateralis of the quadriceps muscle
timeFrame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
measure: Change in cross-sectional area of the m. vastus lateralis of the quadriceps muscle
timeFrame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
measure: Change in capillarisation of the m. vastus lateralis of the quadriceps muscle
timeFrame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
measure: Change in the amount of satellite cells of the m. vastus lateralis of the quadriceps muscle
timeFrame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
measure: Change in gene expression of the m. vastus lateralis of the quadriceps muscle
timeFrame: 8 weeks (+1-2 weeks) and 52 weeks (+1-2 weeks)
measure: Minutes per day spent in at least moderate intense activities
timeFrame: 8 weeks and 52 weeks
measure: Mean walking time per day
timeFrame: 8 weeks and 52 weeks
measure: Mean sedentary time per day
timeFrame: 8 weeks and 52 weeks
measure: Daily number of steps at 8 weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Gent
name: Eric Derom
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Wim Janssens
role: PRINCIPAL_INVESTIGATOR
affiliation: UGent
name: Heleen Demeyer
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Marieke Wuyts
role: PRINCIPAL_INVESTIGATOR
affiliation: U Gent
name: Fien Hermans
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.