NCT05233137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

February 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

January 11, 2022

Last Update Submit

June 17, 2025

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (27)

  • Functional exercise capacity

    8 and 52 weeks

  • Isometric quadriceps force

    52 weeks

  • Functional performance

    8 weeks and 52 weeks

  • Health related quality of life

    8 weeks and 52 weeks

  • Health status

    8 weeks and 52 weeks

  • +22 more secondary outcomes

Study Arms (2)

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

Behavioral: PA coachingOther: Exercise training

PA coaching

ACTIVE COMPARATOR

Patients in this group will receive physical activity telecoaching

Behavioral: PA coaching

Interventions

PA coachingBEHAVIORAL

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.

PA coachingPA coaching and exercise training
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.

PA coaching and exercise training

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Having the current diagnosis of lung cancer or receiving active treatment for oncology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Gent

Ghent, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 38295552BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eric Derom

    UZ Gent

    PRINCIPAL INVESTIGATOR

  • Wim Janssens

    UZ Leuven

    PRINCIPAL INVESTIGATOR

  • Heleen Demeyer

    UGent

    PRINCIPAL INVESTIGATOR

  • Thierry Troosters

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Marieke Wuyts

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Fien Hermans

    U Gent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 10, 2022

Study Start

February 8, 2022

Primary Completion

January 14, 2025

Study Completion

January 14, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations

BE(2)