- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Balçova
-
İzmir, Balçova, Kalkon, 35330
- Dokuz Eylul University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Inspirerande muskelstyrka
Tidsram: 8 veckor
|
Inspiratorisk muskelstyrka (MIP) mättes med hjälp av en handhållen muntrycksanordning (Micro RMP; Micro Medical, Rochester, Storbritannien).
Tre till fem acceptabla och reproducerbara maximala manövrar (dvs skillnader mellan värden <10%) utfördes och det högsta värdet registrerades.
|
8 veckor
|
Expiratorisk muskelstyrka
Tidsram: 8 veckor
|
Expiratorisk muskelstyrka (MEP) mättes med hjälp av en handhållen muntrycksanordning (Micro RMP; Micro Medical, Rochester, Storbritannien).
Tre till fem acceptabla och reproducerbara maximala manövrar (dvs skillnader mellan värden <10%) utfördes och det högsta värdet registrerades.
|
8 veckor
|
Respiratory functions
Tidsram: 8 weeks
|
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.
|
8 weeks
|
Dyspnea assessment
Tidsram: 8 weeks
|
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.
|
8 weeks
|
Exercise capacity assessment
Tidsram: 8 weeks
|
The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.
|
8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Hälsorelaterad livskvalitetsbedömning med hjälp av St. George's Respiratory Questionnaire (SGRQ)
Tidsram: 8 veckor
|
SGRQ är ett specifikt frågeformulär för luftvägssjukdomar.
Det är ett självadministrativt frågeformulär av patienter som ifrågasatte 50 artiklar med 76 viktade svar uppdelade i tre områden: symtom (8 artiklar), aktiviteter (16 artiklar), effekter av sjukdomen (26 artiklar).
De tre delarna av enkäten poängsätts separat och totalpoängen beräknas.
Poäng varierar från 0-100.
Högre poäng indikerar sämre HRQOL.
|
8 veckor
|
Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
Tidsram: 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.
|
8 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sevgi Ozalevli, PT, Prof, Dokuz Eylul University
- Huvudutredare: Ridvan Aktan, PT, PhD, Dokuz Eylul University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RidvanAKTAN_2018.KB.SAG.026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .