- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05501457
The Effect of Different Muscle Training on Activities of Daily Living in COPD
11. august 2022 opdateret af: Ahmet Payas, Hitit University
Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD
Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death.
COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity.
Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD).
Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ahmet Payas, Dr
- Telefonnummer: 05343483399
- E-mail: ahmetpayas@hitit.edu.tr
Studiesteder
-
-
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Corum, Kalkun, 19000
- Rekruttering
- Hititi University Sungurlu Vocational School
-
Kontakt:
- Ahmet Payas
- Telefonnummer: 05343483399
- E-mail: ahmetpayas@hitit.edu.tr
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Being between 18-75 years old,
- Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
- PaO2 >55 mm Hg, PaCO2 <45 mmHg in room air.
Exclusion Criteria:
- Exacerbation,
- Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
- Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
- Musculoskeletal disorder (conditions affecting exercise ability),
- Difficulty communicating.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: The gastrocnemius group
The patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle,
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The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
|
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Eksperimentel: The quadriceps femoris group
The second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2),
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The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
|
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Eksperimentel: The control group
The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3).
|
The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6 Minute Walk Test (6 MWT):
Tidsramme: 4 weeks
|
they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded.
Change from baseline 6 Minute walking performance after 4 weeks will be examined.
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4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified Borg Scale (MBS):
Tidsramme: 4 weeks
|
It consists of 10 items that define the severity of dyspnea according to their degrees.
Change from baseline dyspnea after 4 weeks will be examined.
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4 weeks
|
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St. George's Respiratory Questionnaire (SGRQ):
Tidsramme: 4 weeks
|
This questionnaire was developed specifically to determine the severity of the disease in COPD and asthma.
Change from baseline severity of the disease after 4 weeks will be examined.
|
4 weeks
|
|
Beck Depression Inventory (BDI):
Tidsramme: 4 weeks
|
It measures the behavioral findings of depression in adolescents and adults.
Change from baseline depression status after 4 weeks will be examined.
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4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Ahmet Payas, Dr, HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juli 2022
Primær færdiggørelse (Forventet)
1. oktober 2022
Studieafslutning (Forventet)
1. november 2022
Datoer for studieregistrering
Først indsendt
9. august 2022
Først indsendt, der opfyldte QC-kriterier
11. august 2022
Først opslået (Faktiske)
15. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HititUApayas
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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IPD-planbeskrivelse
A short summary of the study can be shared.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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