NCT07573280

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

physiotherapy and rehabilitationposturepilatesGastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score

    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

Secondary Outcomes (7)

  • Frequency Scale for the Symptoms of GERD (FSSG) total score

    Baseline to Week 6

  • Short Form-36 Health Survey (SF-36) total score

    Baseline to Week 6

  • Pittsburgh Sleep Quality Index (PSQI) global score

    Baseline to Week 6

  • Beck Depression Inventory (BDI) total score

    Baseline to Week 6

  • Postural Alignment Parameters (PostureScreen Mobile)

    Baseline to Week 6

  • +2 more secondary outcomes

Study Arms (2)

No Intervention: Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Usual Daily Activity (No Exercise Intervention)

Experimental: Clinical Pilates Group (PG)

EXPERIMENTAL

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.

Other: Usual Daily Activity (No Exercise Intervention)Behavioral: Supervised Clinical Pilates Exercise Training

Interventions

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.

Experimental: Clinical Pilates Group (PG)No Intervention: Control Group (CG)

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.

Experimental: Clinical Pilates Group (PG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments and data analyses were performed by a researcher blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Single-Blind Trial with parallel allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor, PhD

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

April 1, 2025

Primary Completion

June 15, 2025

Study Completion

June 25, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations