COPD (Chronic Obstructive Pulmonary Disease)NCT07627035
EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.
A study testing Eccentric and concentric aerobic exercice versus only concentric aerobic exercice in people with COPD (Chronic Obstructive Pulmonary Disease) and Pulmonary Rehabilitation, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The aim of this study is to demonstrate the effectiveness of combined concentric and eccentric aerobic training in subjects with COPD, in terms of strength, lung capacity, functionality, and short-term health quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Rehabilitation, Eccentric Exercise Training
- What is being tested?
- Eccentric and concentric aerobic exercice versus only concentric aerobic exercice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with dyspnea grade 2-3 on the mMRC scale.
- Sufficient cognitive and functional level to understand, learn, and carry out the exercise program.
- No contraindications to physical training.
- Active participants.
- Exclusion Criteria: • Recent cardiovascular events such as congestive heart failure, angioplasty or cardiac surgery within the last four weeks, valvular abnormalities requiring surgical correction, myopericarditis, or exercise-induced ventricular arrhythmias.
- Renal failure requiring dialysis.
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- Patients with uncontrolled bronchospasm due to intrinsic asthma.
- Patients undergoing chemotherapy after surgery.
- Severe exercise intolerance due to untreated cardiac arrhythmias, ischemia during low-intensity exercise (unstable angina), severe pulmonary hypertension, or heart failure (NYHA class III or IV).
- Pulmonary embolism with anticoagulant therapy for less than 5 days.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Ramón y Cajal
Madrid, Madrid
Teresa Fernandez Pardo, 0034650193112, teresa.fernandez@universidadeuropea.es
teresa.fpardo@gmail.com
About this study
The aim of this study is to demonstrate the effectiveness of combined concentric and eccentric aerobic training in subjects with COPD, in terms of strength, lung capacity, functionality, and short-term health quality. A randomized, examiner-blinded clinical trial has been designed for this purpose, following the CONSORT guidelines for clinical trials and the ethical principles of the Declaration of Helsinki. A total sample of 40 subjects has been estimated. The study is aimed at patients diagnosed with mild or moderate COPD. A program of 12 group sessions will be conducted over 4 weeks. Each session will last 75 minutes and will include strength exercises and respiratory physiotherapy, common to all subjects. The interval aerobic training will depend on the assigned group: treadmill with negative and positive (or neutral) incline (experimental group), treadmill with positive incline and/or cycle ergometer (control group). The following variables will be measured on the first and last day of treatment, as well as one month after the intervention ends: thickness, cross-sectional area, and ultrasound intensity of the rectus femoris muscle; diaphragmatic excursion and thickness; 5 sit to stand test; get up and go test; Borg scale; maximum respiratory pressures; grip strength in both hands and maximum quadriceps strength; spirometric assessment of FEV1 and SF-12 health quality questionnaire.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Rehabilitation, Eccentric Exercise Training
- Being tested
- Eccentric and concentric aerobic exercice versus only concentric aerobic exercice
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric and concentric aerobic exercice versus only concentric aerobic exerciceOther
For the experimental group: Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes.
For the control group: The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric concentric exercice | Experimental | Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. Receives: Other: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice |
| Concentric exercice | Active comparator | The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes. Receives: Other: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-stand test-5 (STS)
It is a safe and simple test that provides a reliable and objective measure of functional capacity in patients with lung disease, allowing for a rapid interpretation of the patient's progress. It is therefore the primary variable of this study. In this test, the patient is asked to stand up from and sit down from a chair at maximum speed five times, and the time is recorded. The protocol described by Jones et al. will be followed, with a minimum reduction of 1.7 seconds considered significant improvement.
Measured: Baseline and 1 month after
PIM and PEM pressures
The pressure gauge we use is the RP Check. To measure peak expiratory pressure (PEM), the patient places the mouthpiece in their mouth, with the bite blocks between their teeth; they inhale as much air as possible until their lungs are completely full (to total lung capacity) and then exhale with maximum effort and for as long as possible (at least 1.5 seconds). To measure peak inspiratory pressure (PIP), the patient places the mouthpiece in their mouth, exhales as much air as possible to empty their lungs to residual volume, and then inhales with maximum effort and for as long as possible (at least 1.5 seconds). We take three consecutive measurements of each pressure, allowing the patient to rest for one minute between each measurement, and record the best result.
Measured: Baseline and 1 month after
Handgrip
Hand Grip Dynamometer Jamar®, taking into account the dominant hand and possible upper limb injuries that may interfere with the test result
Measured: Baseline and 1 month after
Quadriceps strength
The measurement will be taken on the dominant leg using the MicroFET®2 Digital Handheld Dynamometer following the protocol described by Bohannon et al (
Measured: Baseline and 1 month after
Secondary outcomes (1)
Dyspnea
It consists of a vertical scale from 0-10 that relates the perceived exertion of physical activity to a numerical value ranging from 0 (minimal effort) to 10 (extreme effort). It does not require measuring instruments, as it is a subjective scale.
Measured: Baseline and 1 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Fernandez Pardo, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627035
- Sponsor's protocol ID
- 400-25
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Magunagoikoetxea-Comins G, Jimenez-Garcia ME, Perez-Ferreiro M, Fernandez-Pardo TE. Effects on Exercise Tolerance and Functional Outcomes of Eccentric versus Concentric Aerobic Exercise in People with COPD: A Systematic Review and Meta-Analysis. Int J Chron Obstruct Pulmon Dis. 2025 Dec 18;20:4061-4078. doi: 10.2147/COPD.S558167. eCollection 2025.
PubMed 41446810
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT07627035
- Acronym / sponsor ID
- 400-25
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Pulmonary Rehabilitation, Eccentric Exercise Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate the effectiveness of combined concentric and eccentric aerobic training in subjects with COPD, in terms of strength, lung capacity, functionality, and short-term health quality. A randomized, examiner-blinded clinical trial has been designed for this purpose, following the CONSORT guidelines for clinical trials and the ethical principles of the Declaration of Helsinki. A total sample of 40 subjects has been estimated. The study is aimed at patients diagnosed with mild or moderate COPD. A program of 12 group sessions will be conducted over 4 weeks. Each session will last 75 minutes and will include strength exercises and respiratory physiotherapy, common to all subjects. The interval aerobic training will depend on the assigned group: treadmill with negative and positive (or neutral) incline (experimental group), treadmill with positive incline and/or cycle ergometer (control group). The following variables will be measured on the first and last day of treatment, as well as one month after the intervention ends: thickness, cross-sectional area, and ultrasound intensity of the rectus femoris muscle; diaphragmatic excursion and thickness; 5 sit to stand test; get up and go test; Borg scale; maximum respiratory pressures; grip strength in both hands and maximum quadriceps strength; spirometric assessment of FEV1 and SF-12 health quality questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric concentric exercice | Experimental | Other: Eccentric and concentric aerobic exercice versus only concentric aerobic exerciceAerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. |
| Concentric exercice | Active comparator | Other: Eccentric and concentric aerobic exercice versus only concentric aerobic exerciceThe aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Present with dyspnea grade 2-3 on the mMRC scale.
- Sufficient cognitive and functional level to understand, learn, and carry out the exercise program.
- No contraindications to physical training.
- Active participants.
- Exclusion Criteria: • Recent cardiovascular events such as congestive heart failure, angioplasty or cardiac surgery within the last four weeks, valvular abnormalities requiring surgical correction, myopericarditis, or exercise-induced ventricular arrhythmias.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric and concentric aerobic exercice versus only concentric aerobic exerciceFor the experimental group: Aerobic exercise will be performed in interval mode, alternating between treadmill walking with a negative incline of up to -6% and treadmill walking with an positive incline. For the intervention group, this will consist of a 2-minute interval at the estimated MET workload, followed by a 4-minute interval at half the intensity. The total duration will be between 20 and 30 minutes. For the control group: The aerobic exercise will be performed in interval mode, on a treadmill with an incline and/or cycle ergometer, consisting of a 2-minute interval at the estimated workload in METs, followed by another 4-minute interval at half the intensity. It will last between 20 and 30 minutes. | Other | Concentric exercice, Eccentric concentric exercice |
Primary outcome
Sit-to-stand test-5 (STS)
Time frame: Baseline and 1 month after
It is a safe and simple test that provides a reliable and objective measure of functional capacity in patients with lung disease, allowing for a rapid interpretation of the patient's progress. It is therefore the primary variable of this study. In this test, the patient is asked to stand up from and sit down from a chair at maximum speed five times, and the time is recorded. The protocol described by Jones et al. will be followed, with a minimum reduction of 1.7 seconds considered significant improvement.
PIM and PEM pressures
Time frame: Baseline and 1 month after
The pressure gauge we use is the RP Check. To measure peak expiratory pressure (PEM), the patient places the mouthpiece in their mouth, with the bite blocks between their teeth; they inhale as much air as possible until their lungs are completely full (to total lung capacity) and then exhale with maximum effort and for as long as possible (at least 1.5 seconds). To measure peak inspiratory pressure (PIP), the patient places the mouthpiece in their mouth, exhales as much air as possible to empty their lungs to residual volume, and then inhales with maximum effort and for as long as possible (at least 1.5 seconds). We take three consecutive measurements of each pressure, allowing the patient to rest for one minute between each measurement, and record the best result.
Handgrip
Time frame: Baseline and 1 month after
Hand Grip Dynamometer Jamar®, taking into account the dominant hand and possible upper limb injuries that may interfere with the test result
Quadriceps strength
Time frame: Baseline and 1 month after
The measurement will be taken on the dominant leg using the MicroFET®2 Digital Handheld Dynamometer following the protocol described by Bohannon et al (
1 secondary outcome
Dyspnea
Time frame: Baseline and 1 month after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 41446810Magunagoikoetxea-Comins G, Jimenez-Garcia ME, Perez-Ferreiro M, Fernandez-Pardo TE. Effects on Exercise Tolerance and Functional Outcomes of Eccentric versus Concentric Aerobic Exercise in People with COPD: A Systematic Review and Meta-Analysis. Int J Chron Obstruct Pulmon Dis. 2025 Dec 18;20:4061-4078. doi: 10.2147/COPD.S558167. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric and concentric aerobic exercice versus only concentric aerobic exercice in people with COPD (Chronic Obstructive Pulmonary Disease) and Pulmonary Rehabilitation, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Fernandez Pardo, PT, Msc, PhD (0034650193112, teresa.fernandez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit-to-stand test-5 (STS) (time frame: Baseline and 1 month after). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07627035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.