EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.

NCT07627035 | Not Yet Recruiting

• 1 other identifier: 400-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Pulmonary Rehabilitation; Eccentric Exercise Training; COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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 (

  Baseline and 1 month after

Secondary Outcomes (1)

• Dyspnea

  Baseline and 1 month after

Study Arms (2)

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.

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.

Other: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice

Interventions

Eccentric and concentric aerobic exercice versus only concentric aerobic exercice OTHER

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.

Concentric exercice; Eccentric concentric exercice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Renal failure requiring dialysis.
• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 41446810 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Teresa Fernandez Pardo, PT, Msc, PhD

CONTACT

0034650193112; teresa.fernandez@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

ES (1)