EFFECTIVENESS OF COMBINED CONCENTRIC AND ECCENTRIC AEROBIC EXERCISE ON A TREADMILL IN PATIENTS WITH COPD: A RANDOMIZED CLINICAL TRIAL.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Teresa Fernandez Pardo, PT, Msc, PhD
- Numer telefonu: 0034650193112
- E-mail: teresa.fernandez@universidadeuropea.es
Lokalizacje studiów
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Madrid
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Madrid, Madrid, Hiszpania
- Hospital Ramón Y Cajal
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Kontakt:
- Teresa Fernandez Pardo
- Numer telefonu: 0034650193112
- E-mail: teresa.fernandez@universidadeuropea.es
-
Kontakt:
- E-mail: teresa.fpardo@gmail.com
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Główny śledczy:
- Teresa Fernandez Pardo
-
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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. |
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Aktywny 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.
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sit-to-stand test-5 (STS)
Ramy czasowe: 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.
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Baseline and 1 month after
|
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PIM and PEM pressures
Ramy czasowe: 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.
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Baseline and 1 month after
|
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Handgrip
Ramy czasowe: 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
|
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Quadriceps strength
Ramy czasowe: 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 (
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Baseline and 1 month after
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dyspnea
Ramy czasowe: 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
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 400-25
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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