- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05233137
Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thierry Troosters
- Phone Number: 003216330798
- Email: thierry.troosters@kuleuven.be
Study Locations
-
-
-
Gent, Belgium
- Recruiting
- UZ Gent
-
Contact:
- Eric Derom
-
Leuven, Belgium
- Recruiting
- University Hospitals Leuven
-
Contact:
- Thierry Troosters
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
Each session will include at least the following components:
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. |
Active Comparator: PA coaching
Patients in this group will receive physical activity telecoaching
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
52 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional exercise capacity
Time Frame: 8 and 52 weeks
|
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.
|
8 and 52 weeks
|
Isometric quadriceps force
Time Frame: 52 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.
|
52 weeks
|
Functional performance
Time Frame: 8 weeks and 52 weeks
|
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:
|
8 weeks and 52 weeks
|
Health related quality of life
Time Frame: 8 weeks and 52 weeks
|
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. |
8 weeks and 52 weeks
|
Health status
Time Frame: 8 weeks and 52 weeks
|
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). |
8 weeks and 52 weeks
|
Patient experience of PA
Time Frame: 8 weeks and 52 weeks
|
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
|
8 weeks and 52 weeks
|
Change in high-density lipoprotein (HDL)
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Change in low-density lipoprotein (LDL)
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Change in total cholesterol
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Change in triglycerides
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient and triglycerides) and blood pressure
|
8 weeks and 52 weeks
|
Change in blood pressure
Time Frame: 8 weeks and 52 weeks
|
By taking the systolic and diastolic blood pressure of the patient at rest
|
8 weeks and 52 weeks
|
Change in weight
Time Frame: 8 weeks and 52 weeks
|
By taking the weight of the patient
|
8 weeks and 52 weeks
|
Change in waist and hip circumference
Time Frame: 8 weeks and 52 weeks
|
The waist and hip circumference will be measured and risk factors fasting blood sample (glucose level, insulin Hba1c)
|
8 weeks and 52 weeks
|
Change in insulin
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Change in glucose level
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Change in Hba1c
Time Frame: 8 weeks and 52 weeks
|
By taking a fasting blood sample of the patient
|
8 weeks and 52 weeks
|
Day to day Physical Activity
Time Frame: 52 weeks
|
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.
|
52 weeks
|
Number of AECOPD
Time Frame: 52 weeks
|
Number of AECOPD following the index AECOPD
|
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)
|
By analysing muscle microbiopsies of the quadriceps muscle immunostaining of the myosin heavy chain, only for patients giving their specific consent.
|
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)
|
By analysing muscle microbiopsies of the quadriceps muscle immunostaining of the myosin heavy chain, only for patients giving their specific consent.
|
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)
|
By analysing muscle microbiopsies of the quadriceps muscle, only for patients giving their specific consent.
|
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)
|
By analysing muscle microbiopsies with Pax7 immunostaining of the quadriceps muscle, only for patients giving their specific consent.
|
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)
|
By analysing muscle microbiopsies with RT2 profiler PCR array skeletal muscle, Qiagen of the quadriceps muscle, only for patients giving their specific consent.
|
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
|
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.
|
8 weeks and 52 weeks
|
Mean walking time per day
Time Frame: 8 weeks and 52 weeks
|
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.
|
8 weeks and 52 weeks
|
Mean sedentary time per day
Time Frame: 8 weeks and 52 weeks
|
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.
|
8 weeks and 52 weeks
|
Daily number of steps at 8 weeks
Time Frame: 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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S65813
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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