- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07573280
Effects of Clinical Pilates Exercises on Symptoms, Posture, Balance and Quality of Life in GERD
1. května 2026 aktualizováno: 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).
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
33
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Istanbul, Turecko (Türkiye)
- Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Frequency Scale for the Symptoms of GERD (FSSG) total score
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Short Form-36 Health Survey (SF-36) total score
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Pittsburgh Sleep Quality Index (PSQI) global score
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Beck Depression Inventory (BDI) total score
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Postural Alignment Parameters (PostureScreen Mobile)
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Y-Balance Test reach distances
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
|
Anthropometric circumference measurements
Časové okno: Baseline to Week 6
|
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.
|
Baseline to Week 6
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. dubna 2025
Primární dokončení (Aktuální)
15. června 2025
Dokončení studie (Aktuální)
25. června 2025
Termíny zápisu do studia
První předloženo
1. května 2026
První předloženo, které splnilo kritéria kontroly kvality
1. května 2026
První zveřejněno (Aktuální)
7. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GERD-P 25-29
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Gastro ezofageální reflux
-
Cleveland Clinic LondonZápis na pozvánkuLaryngofaryngeální reflux | Gastro -eozofagální refluxSpojené arabské emiráty, Rakousko, Itálie, Srbsko, Švýcarsko, Turecko (Türkiye), Spojené království
-
Medical University of ViennaNeznámý
-
Shandong UniversityZatím nenabírámeUmělá inteligence | Reflux žluči | JazykČína
-
University Hospital MuensterDokončenoReflux, Gastroezofageální | Refluxní nemoc | Reflux, LaryngofaryngeálníNěmecko
-
Samsung Medical CenterDokončenoVezikoureterální refluxKorejská republika
-
Stanford UniversityDokončenoVezikoureterální refluxSpojené státy
-
Aplos MedicalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Aktivní, ne nábor
-
St. Luke's Medical Center, PhilippinesDokončenoInfekce močových cest | Vezikoureterální reflux (VUR)Filipíny
-
Medtronic EndovascularVNUS Medical Technologies, A Covidien CompanyDokončeno
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)DokončenoGastroezofageální refluxní choroba | GERD | Acid Reflux | RefluxSpojené státy