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

31. Mai 2026 aktualisiert von: Teresa Fernandez Pardo, Universidad Europea de Madrid
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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria: • Subjects >18 years old.

  • 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.
  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Eccentric concentric exercice
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.
Sonstiges: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice

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.
Aktiver Komparator: Concentric exercice
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.
Sonstiges: Eccentric and concentric aerobic exercice versus only concentric aerobic exercice

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sit-to-stand test-5 (STS)
Zeitfenster: 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.
Baseline and 1 month after
PIM and PEM pressures
Zeitfenster: 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.
Baseline and 1 month after
Handgrip
Zeitfenster: 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
Baseline and 1 month after
Quadriceps strength
Zeitfenster: 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 (
Baseline and 1 month after

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Dyspnea
Zeitfenster: Baseline and 1 month after
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.
Baseline and 1 month after

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universidad Europea de Madrid

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. September 2028

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Mai 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 400-25

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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