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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04655534
The Effect of Inspiratory Muscle Warm-Up in Patients With COPD
The Effect of Inspiratory Muscle Warm-Up Prior to Inspiratory Muscle Training in Addition to Exercise Training in Patients With COPD
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Chronic obstructive pulmonary disease (COPD) is a disease that leads to increased morbidity and mortality with severe pulmonary complications. The Global Burden of Disease studies have estimated that COPD is the third leading cause of death worldwide. The effects of COPD are not only limited to the lungs but also affects other organs and systems, causing loss of strength in the respiratory and peripheral muscles, which leading to a decreased capacity for exercise. Respiratory muscles are the skeletal muscles that can be trained based on the principles of exercise just like peripheral muscles. It is known that while doing exercise training in peripheral muscles, more muscle performance can be achieved by warming up those muscles before the loading phase. In this study, it is aimed to investigate the effect of inspiratory muscle warm-up (IMW) performed before inspiratory muscle training (IMT) in addition to general exercise training on respiratory functions, respiratory muscle strength, exercise capacity, perceived dyspnea intensity and health-related quality of life in patients with COPD.
Participants were randomly divided into two groups as the study group (IMW Group) and the control group (Standard IMT Group). The Standard IMT Group performed only IMT, while the IMW Group performed an IMW protocol for warming the inspiratory muscles before each IMT session. The IMT and IMW were applied using a threshold pressure loading device. The IMT applied as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP). The intensity of MIP adjusts by two weekly MIP measurements. The protocol of IMW consists of 2 sets of 30 breaths at 40% of MIP, with 1 min rest between sets, using a threshold inspiratory muscle trainer. Then the respiratory exercises and aerobic exercise program performed in both groups in each session. Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down. All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor. Demographic features questioned and recorded in the data recording form through a mutual interview in patients who meet the inclusion criteria. All patients evaluated before treatment and after treatment.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Balçova
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İzmir, Balçova, Tacchino, 35330
- Dokuz Eylul University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria
- Having a Maximal inspiratory pressure (MIP) less than 60 cmH2O
- Aged between 45 and 70 years
- Independent mobilization
- Volunteering to research
- Stable clinical condition (same medication routine without taking any antibiotics for the last 3 weeks and/or no acute exacerbation in the last 3 months)
Exclusion Criteria:
- Not quitting smoking
- A previous pneumonectomy or lobectomy operation.
- Pneumonia in the last 3 months.
- Any pulmonary infection during the study.
- Requirement for supplemental oxygen therapy
- Orthopaedic or neurological conditions effecting the ability to exercise
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: IMW Group
Patients who performed inspiratory muscle warm-up (IMW) before inspiratory muscle training (IMT)
|
The IMW protocol applied before each inspiratory muscle training (IMT) session by using a threshold inspiratory muscle trainer.
The IMW protocol consists of 2 sets of 30 breaths in 40% of the maximal inspiratory pressure (MIP), with 1 min rest between sets.
The intensity of MIP adjusted by two weekly MIP measurements.
The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP).
The intensity of MIP adjusted by two weekly MIP measurements.
Then the respiratory exercises and aerobic exercise program performed in both groups in each session.
Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down.
All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
|
|
Sperimentale: Standart IMT Group
Patients who performed standard inspiratory muscle training (IMT) without inspiratory muscle warm-up (IMW) protocol
|
The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP).
The intensity of MIP adjusted by two weekly MIP measurements.
Then the respiratory exercises and aerobic exercise program performed in both groups in each session.
Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down.
All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Forza muscolare inspiratoria
Lasso di tempo: 8 settimane
|
La forza dei muscoli inspiratori (MIP) è stata misurata utilizzando un dispositivo portatile per la pressione della bocca (Micro RMP; Micro Medical, Rochester, Regno Unito).
Sono state eseguite da tre a cinque manovre massime accettabili e riproducibili (cioè differenze tra valori <10%) ed è stato registrato il valore più alto.
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8 settimane
|
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Forza muscolare espiratoria
Lasso di tempo: 8 settimane
|
La forza muscolare espiratoria (MEP) è stata misurata utilizzando un dispositivo per la pressione della bocca portatile (Micro RMP; Micro Medical, Rochester, Regno Unito).
Sono state eseguite da tre a cinque manovre massime accettabili e riproducibili (cioè differenze tra valori <10%) ed è stato registrato il valore più alto.
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8 settimane
|
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Respiratory functions
Lasso di tempo: 8 weeks
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Respiratory functions were evaluated by pulmonary function tests.
Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Sensor Medics Vmax 22 machine, SensorMedics Inc., Anaheim, CA).
Percentages of forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1 / FVC ratio values relative to the predicted value were recorded in pulmonary function tests.
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8 weeks
|
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Dyspnea assessment
Lasso di tempo: 8 weeks
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The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea.
Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
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8 weeks
|
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Exercise capacity assessment
Lasso di tempo: 8 weeks
|
The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.
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8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Valutazione della qualità della vita correlata alla salute utilizzando il questionario respiratorio di San Giorgio (SGRQ)
Lasso di tempo: 8 settimane
|
Il SGRQ è un questionario specifico per le malattie respiratorie.
Si tratta di un questionario autosomministrato dai pazienti che ha interrogato 50 item con 76 risposte ponderate suddivise in tre aree: sintomi (8 item), attività (16 item), effetti della malattia (26 item).
Le tre parti del questionario vengono valutate separatamente e viene calcolato il punteggio totale.
I punteggi vanno da 0 a 100.
Punteggi più alti che indicano una HRQOL peggiore.
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8 settimane
|
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Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
Lasso di tempo: 8 weeks
|
The SF-36 is a general quality of life survey which includes 36 items and enables the measurement of eight sections; physical functioning, social role functioning, physical role functioning, emotional role functioning, mental health, vitality, bodily pain and general health perceptions.
Each category is scored from 0 to 100.
Lower scores indicating worse HRQOL.
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8 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Sevgi Ozalevli, PT, Prof, Dokuz Eylul University
- Investigatore principale: Ridvan Aktan, PT, PhD, Dokuz Eylul University
Pubblicazioni e link utili
Pubblicazioni generali
- Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458.
- Bisca GW, Camillo CA, Cavalheri V, Pitta F, Osadnik CR. Peripheral muscle training in patients with chronic obstructive pulmonary disease: novel approaches and recent advances. Expert Rev Respir Med. 2017 May;11(5):413-423. doi: 10.1080/17476348.2017.1317598. Epub 2017 Apr 17.
- Volianitis S, McConnell AK, Koutedakis Y, Jones DA. Specific respiratory warm-up improves rowing performance and exertional dyspnea. Med Sci Sports Exerc. 2001 Jul;33(7):1189-93. doi: 10.1097/00005768-200107000-00017.
- Ross EZ, Nowicky AV, McConnell AK. Influence of acute inspiratory loading upon diaphragm motor-evoked potentials in healthy humans. J Appl Physiol (1985). 2007 May;102(5):1883-90. doi: 10.1152/japplphysiol.00694.2006. Epub 2007 Jan 18.
- Ozdal M. Acute effects of inspiratory muscle warm-up on pulmonary function in healthy subjects. Respir Physiol Neurobiol. 2016 Jun 15;227:23-6. doi: 10.1016/j.resp.2016.02.006. Epub 2016 Feb 21.
- Lomax M, Grant I, Corbett J. Inspiratory muscle warm-up and inspiratory muscle training: separate and combined effects on intermittent running to exhaustion. J Sports Sci. 2011 Mar;29(6):563-9. doi: 10.1080/02640414.2010.543911.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RidvanAKTAN_2018.KB.SAG.026
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