- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07573280
Effects of Clinical Pilates Exercises on Symptoms, Posture, Balance and Quality of Life in GERD
1. Mai 2026 aktualisiert von: Mirsad Alkan, Istinye University
The Effect of Clinical Pilates Exercises on Symptoms, Posture, Balance and Quality of Life in Individuals With Gastroesophageal Reflux Disease
This randomized, single-blind, parallel-group clinical trial investigates whether a six-week supervised clinical Pilates exercise program improves reflux symptom severity, postural alignment, dynamic balance, sleep quality, depressive symptoms, anthropometric measures, and overall health-related quality of life in adults with gastroesophageal reflux disease (GERD).
Participants attended 18 face-to-face sessions over 6 weeks (3 times/week) under physiotherapist supervision.
Outcomes included reflux symptom scores (GERD-Q, FSSG), health-related quality of life (SF-36), sleep quality (Pittsburgh Sleep Quality Index), depression (Beck Depression Inventory), postural alignment (PostureScreen Mobile), dynamic balance (Y-Balance Test), and anthropometric circumferences (chest, sub-sternal, waist).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
Design: randomized controlled, single-blind, parallel-group trial conducted at Istinye University Physiotherapy and Rehabilitation Application and Research Center (FIZYOTEM).
Eligible adults (18-65 years) with a clinically confirmed diagnosis of gastroesophageal reflux disease and self-reported GERD symptoms for at least three months, who were physiologically able to participate in low-to-moderate intensity exercise, were enrolled.
Allocation followed a computer-generated random sequence with concealed assignment to: (1) Clinical Pilates Group (PG): a progressive, posture-focused clinical Pilates program performed exclusively in the standing position to minimize intra-abdominal pressure, with no anterior trunk flexion or direct abdominal compression; (2) Control Group (CG): usual daily activity with no exercise intervention.
The Pilates group completed 18 supervised face-to-face sessions across 6 weeks (3 sessions/week).
Each session included a ~10-minute warm-up (Cleopatra, upper-extremity PNF patterns, Toy Soldier, Corkscrew, Chest Stretch), a main phase (Tic-Toc Arm Float, Bow & Arrow, Spine Twist, Footwork, Knee Lift & Aeroplane, Plié - Second to First - Moving Balance, Balance, Balance Plié with Arms), and a 5-10-minute cool-down/stretching phase.
Progression across the 6 weeks was achieved by increasing repetitions (5 → 10) and active duration (5 s → 10 s → 15 s) while maintaining one set per exercise and a 30-second rest interval.
To minimize gastric distension, sessions were scheduled at least 2 hours after a main meal or at least 30 minutes before eating.
Assessments were performed pre- and post-intervention in fixed order with rest intervals.
Reflux symptom severity was quantified using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q) and the Frequency Scale for the Symptoms of GERD (FSSG).
Health-related quality of life was assessed with the Short Form-36 (SF-36); sleep quality with the Pittsburgh Sleep Quality Index (PSQI); depressive symptoms with the Beck Depression Inventory (BDI).
Postural alignment was analyzed using the PostureScreen Mobile application (anterior, posterior, right and left lateral views; sagittal and frontal translations and angulations).
Dynamic balance was measured with the Y-Balance Test (anterior, posteromedial, posterolateral reach, bilateral).
Anthropometric circumferences (chest, sub-sternal, waist) were measured with a standard tape.
Statistical plan: distribution evaluated with the Shapiro-Wilk test; within-group changes assessed using paired-samples t-test or Wilcoxon signed-rank test as appropriate; between-group comparisons using independent-samples t-test or Mann-Whitney U test; categorical variables with chi-square test.
Analyses were performed in IBM SPSS Statistics v25.0 with a two-tailed alpha of 0.05.
Sample size was estimated a priori (G*Power 3.1) for a moderate effect (d=0.6), α=0.05, power=0.80,
yielding 19 participants per group; post-hoc power for the primary outcome (GERD-Q) reached 0.96 (d=1.37).
No external funding; no conflicts declared.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
33
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Istanbul, Türkei (türkiye)
- Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Age 18-65 years.
- Clinically confirmed diagnosis of gastroesophageal reflux disease (GERD).
- Self-reported GERD symptoms (heartburn, acid regurgitation, etc.) for at least 3 months prior to enrollment.
- Physiologically able to participate in low-to-moderate intensity exercise.
- Provision of written informed consent.
- Cognitive and psychosocial capacity to comply with the program.
Exclusion Criteria:
- History of upper gastrointestinal surgery (especially fundoplication).
- Achalasia or severe esophageal motility disorder.
- Endoscopic evidence of advanced esophagitis, Barrett's esophagus, or esophageal stricture (complicated GERD).
- Active peptic ulcer disease or inflammatory bowel disease.
- Uncontrolled hypertension, coronary artery disease, or severe pulmonary disease.
- Severe musculoskeletal disorders (advanced scoliosis/kyphosis, acute disc herniation, severe osteoarthritis) or vestibular balance disorders.
- Pregnancy or suspected pregnancy.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: No Intervention: Control Group (CG)
Participants continued their routine daily activities without any structured exercise intervention for the 6-week study period.
Outcome measurements were performed at baseline and at week 6 using identical procedures and instruments as the Pilates group.
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No supervised exercise; participants were instructed to maintain their usual physical activity pattern and lifestyle for 6 weeks.
They received the same baseline and week-6 assessments as the experimental group.
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Experimental: Experimental: Clinical Pilates Group (PG)
Posture-focused clinical Pilates exercise program tailored for individuals with GERD.
All exercises were performed in the standing position, avoiding anterior trunk flexion and direct abdominal compression to minimize intra-abdominal pressure.
Sessions were held 3 times/week for 6 weeks (18 supervised face-to-face sessions).
Each session contained a ~10-minute warm-up, a main phase of standing posture/balance Pilates exercises, and a 5-10-minute cool-down/stretching phase.
|
No supervised exercise; participants were instructed to maintain their usual physical activity pattern and lifestyle for 6 weeks.
They received the same baseline and week-6 assessments as the experimental group.
18 face-to-face sessions over 6 weeks (3×/week); physiotherapist-led, posture-focused program performed exclusively in the standing position.
Warm-up/cool-down: Cleopatra, upper-extremity PNF patterns, Toy Soldier, Corkscrew, Chest Stretch (10 reps each).
Main phase: Tic-Toc Arm Float, Bow & Arrow, Spine Twist, Footwork, Knee Lift & Aeroplane, Plié - Second to First - Moving Balance, Balance, Balance Plié with Arms.
Progression by repetitions (5 → 10) and active duration (5 s → 10 s → 15 s); one set per exercise; 30-second rest between sets.
Sessions were timed at least 2 hours after meals or at least 30 minutes before eating to limit gastric distension.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score
Zeitfenster: Baseline to Week 6
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Six-item self-report instrument measuring frequency of typical reflux symptoms over the past week; total score range 0-18, with higher scores indicating greater symptom burden and a cut-off of ≥8 suggesting high probability of GERD.
Safety Issue: No.
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Baseline to Week 6
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Frequency Scale for the Symptoms of GERD (FSSG) total score
Zeitfenster: Baseline to Week 6
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Twelve-item self-report scale assessing the frequency of acid-reflux and dyspeptic symptoms; total score range 0-48, with higher scores indicating more frequent symptoms (≥8 considered positive for GERD).
Safety Issue: No.
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Baseline to Week 6
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Short Form-36 Health Survey (SF-36) total score
Zeitfenster: Baseline to Week 6
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36-item generic health-related quality-of-life questionnaire covering eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health); each domain and the total score scaled 0-100, higher scores reflecting better health-related quality of life.
Safety Issue: No.
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Baseline to Week 6
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Pittsburgh Sleep Quality Index (PSQI) global score
Zeitfenster: Baseline to Week 6
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19-item self-report instrument generating a global score from seven components (subjective sleep quality, latency, duration, efficiency, disturbances, medication use, daytime dysfunction); global score 0-21, with higher scores indicating poorer sleep quality (≥5 indicates poor sleep).
Safety Issue: No.
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Baseline to Week 6
|
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Beck Depression Inventory (BDI) total score
Zeitfenster: Baseline to Week 6
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21-item self-report inventory assessing severity of depressive symptoms over the past week; total score 0-63, with higher scores indicating greater depressive symptom severity.
Safety Issue: No.
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Baseline to Week 6
|
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Postural Alignment Parameters (PostureScreen Mobile)
Zeitfenster: Baseline to Week 6
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Photographic postural assessment performed in anterior, posterior, right and left lateral standing views using the PostureScreen Mobile application.
Outcomes include sagittal anterior translations and posterior translations of head, shoulder, thorax, pelvis, and segmental spinal translations (T1-T4, T4-T8, T8-T12, T12-L3, L3-SIPS); frontal lateral translations of head, shoulder, pelvis, and knee.
Values reported in cm and degrees; values closer to zero indicate better postural alignment.
Safety Issue: No.
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Baseline to Week 6
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Y-Balance Test reach distances
Zeitfenster: Baseline to Week 6
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Dynamic balance assessment in which participants reach as far as possible in three directions (anterior, posteromedial, posterolateral) on each lower limb while maintaining single-leg stance.
Maximum reach distance is recorded in centimeters bilaterally; greater reach distances reflect better dynamic balance and lower-limb neuromuscular control.
Safety Issue: No.
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Baseline to Week 6
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Anthropometric circumference measurements
Zeitfenster: Baseline to Week 6
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Tape-measure assessment of chest circumference, sub-sternal (sub-xiphoid) circumference, and waist circumference, recorded in centimeters using standardized landmarks at end-tidal expiration.
Safety Issue: No.
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Baseline to Week 6
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2025
Primärer Abschluss (Tatsächlich)
15. Juni 2025
Studienabschluss (Tatsächlich)
25. Juni 2025
Studienanmeldedaten
Zuerst eingereicht
1. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Mai 2026
Zuerst gepostet (Tatsächlich)
7. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GERD-P 25-29
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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