- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07650929
Pilates With Diaphragmatic Breathing in Sedentary Women (PDB-Pilates)
11. juni 2026 opdateret af: Veli Volkan Gürses, Bandırma Onyedi Eylül University
Effects of Pilates Combined With Diaphragmatic Breathing on Cardiopulmonary Markers in Sedentary Women: A Randomized Controlled Trial
This randomized controlled trial evaluated whether adding diaphragmatic breathing exercises to an eight-week supervised Pilates program improves pulmonary function, resting heart rate, and core endurance in sedentary women aged 35 years and older.
Participants were randomized to Pilates combined with diaphragmatic breathing or Pilates alone.
Both groups trained three times per week for eight weeks.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Participants were sedentary women aged 35 years and older who had not participated in regular structured exercise during the previous six months.
Participants were randomly assigned in a 1:1 ratio to either Pilates combined with diaphragmatic breathing exercises or Pilates alone.
Both groups completed supervised exercise sessions three times per week for eight weeks.
Each session lasted approximately 60 minutes and included warm-up, main Pilates exercises, and cool-down.
The experimental group additionally performed structured diaphragmatic and abdominal breathing exercises integrated into the Pilates sessions.
Pulmonary function, cardiovascular parameters, functional performance, anthropometry, and echocardiographic safety parameters were assessed at baseline and after the intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Bandırma
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Balıkesir, Bandırma, Tyrkiet (Türkiye), 10010
- Bandirma Onyedi Eylul University, Faculty of Medicine
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Female participants aged 35 years or older
- Sedentary status, defined as no regular structured exercise participation during the previous six months
- Non-smoker
- No diagnosed cardiovascular, pulmonary, or musculoskeletal disorder
- Not using medications known to influence cardiopulmonary function
- Provided written informed consent
Exclusion Criteria:
- Pregnancy
- Recent surgery or injury
- Participation in another structured exercise program during the study period
- Any cardiovascular, pulmonary, or musculoskeletal condition that could affect safe participation
- Use of medication known to influence cardiopulmonary function
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pilates Exercise Diaphragmatic Breathing Exercise
Participants completed an eight-week supervised Pilates program combined with structured diaphragmatic and abdominal breathing exercises.
Sessions were performed three times per week and lasted approximately 60 minutes.
|
Participants completed a supervised mat-based Pilates exercise program three times per week for eight weeks.
Each session lasted approximately 60 minutes and included a warm-up phase, a main Pilates exercise component targeting core stability, flexibility, postural alignment, and muscular endurance, and a cool-down phase.
Participants performed structured diaphragmatic and abdominal breathing exercises integrated into the Pilates sessions.
The breathing protocol included slow nasal inhalation, controlled oral exhalation, abdominal expansion, segmental thoracic breathing, and guided breathing rhythm during selected Pilates exercises.
|
|
Aktiv komparator: Pilates Alone
Participants completed the same eight-week supervised Pilates program without specific diaphragmatic breathing instruction.
Sessions were performed three times per week and lasted approximately 60 minutes.
|
Participants completed a supervised mat-based Pilates exercise program three times per week for eight weeks.
Each session lasted approximately 60 minutes and included a warm-up phase, a main Pilates exercise component targeting core stability, flexibility, postural alignment, and muscular endurance, and a cool-down phase.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Peak Expiratory Flow
Tidsramme: Baseline and after 8 weeks
|
Peak expiratory flow was assessed by spirometry.
The change from baseline to the end of the eight-week intervention was evaluated.
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Baseline and after 8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Forced Vital Capacity
Tidsramme: Baseline and after 8 weeks
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Forced vital capacity was assessed by spirometry.
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Baseline and after 8 weeks
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Change in Forced Expiratory Volume in One Second
Tidsramme: Baseline and after 8 weeks
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FEV1 was assessed by spirometry.
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Baseline and after 8 weeks
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Change in FEV1/FVC Ratio
Tidsramme: Baseline and after 8 weeks
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The FEV1/FVC ratio was calculated from spirometric measurements.
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Baseline and after 8 weeks
|
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Change in Resting Heart Rate
Tidsramme: Baseline and after 8 weeks
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Resting heart rate was measured after at least 10 minutes of seated rest.
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Baseline and after 8 weeks
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Change in Plank Test Performance
Tidsramme: Baseline and after 8 weeks
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Core muscular endurance was assessed using the prone plank test, recorded in seconds.
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Baseline and after 8 weeks
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Change in Echocardiographic Safety Parameters
Tidsramme: Baseline and after 8 weeks
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Echocardiographic parameters including ejection fraction, ventricular dimensions, wall thickness, and flow velocities were evaluated for safety monitoring.
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Baseline and after 8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: DUYGU DURMAZ, PHD, Bandirma Onyedi Eylul University, Faculty of Medicine
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)
3. juni 2025
Primær færdiggørelse (Faktiske)
5. september 2025
Studieafslutning (Faktiske)
7. oktober 2025
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
16. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BANU-PILATES-DB-2025-76
- Other Identifier (Anden identifikator: 2025-76)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data underlying the results reported in the article will be made available upon reasonable request.
IPD-delingstidsramme
Beginning after publication and available for 5 years.
IPD-delingsadgangskriterier
Data will be shared with researchers who submit a methodologically sound proposal and obtain approval from the corresponding author and, if required, the institutional ethics committee.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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