Pilates ExerciseNCT07573280
Effects of Clinical Pilates Exercises on Symptoms, Posture, Balance and Quality of Life in GERD
A study testing Usual Daily Activity (No Exercise Intervention) and Supervised Clinical Pilates Exercise Training in people with Pilates Exercise and Gastro Esophageal Reflux, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pilates Exercise, Gastro Esophageal Reflux
- What is being tested?
- Usual Daily Activity (No Exercise Intervention) and Supervised Clinical Pilates Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Istanbul
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Pilates Exercise, Gastro Esophageal Reflux
- Being tested
- Usual Daily Activity (No Exercise Intervention), Supervised Clinical Pilates Exercise Training
- Keywords
- physiotherapy and rehabilitation, posture, pilates, Gastro Esophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Daily Activity (No Exercise Intervention)Other
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.
Supervised Clinical Pilates Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Daily Activity (No Exercise Intervention); Behavioral: Supervised Clinical Pilates Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6
Secondary outcomes (7)
Frequency Scale for the Symptoms of GERD (FSSG) total score
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.
Measured: Baseline to Week 6
Short Form-36 Health Survey (SF-36) total score
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.
Measured: Baseline to Week 6
Pittsburgh Sleep Quality Index (PSQI) global score
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.
Measured: Baseline to Week 6
Beck Depression Inventory (BDI) total score
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.
Measured: Baseline to Week 6
Postural Alignment Parameters (PostureScreen Mobile)
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.
Measured: Baseline to Week 6
Y-Balance Test reach distances
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.
Measured: Baseline to Week 6
Anthropometric circumference measurements
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.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Apr 2025
- Primary completion15 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilates ExerciseStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Single-Blind Trial with parallel allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirsad Alkan, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573280
- Sponsor's protocol ID
- GERD-P 25-29
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clinical Pilates Exercises on Symptoms, Posture, Balance and Quality of Life in Individuals With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07573280
- Acronym / sponsor ID
- GERD-P 25-29
- Conditions
- Pilates Exercise, Gastro Esophageal Reflux
- Keywords
- physiotherapy and rehabilitation, posture, pilates, Gastro Esophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Single-Blind Trial with parallel allocation
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control Group (CG) | Active comparator | Other: Usual Daily Activity (No Exercise Intervention)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. |
| Experimental: Clinical Pilates Group (PG) | Experimental | Other: Usual Daily Activity (No Exercise Intervention), Behavioral: Supervised Clinical Pilates Exercise TrainingPosture-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Daily Activity (No Exercise Intervention)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. | Other | Experimental: Clinical Pilates Group (PG), No Intervention: Control Group (CG) |
| Supervised Clinical Pilates Exercise Training18 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. | Behavioural | Experimental: Clinical Pilates Group (PG) |
Primary outcome
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score
Time frame: 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.
7 secondary outcomes
Frequency Scale for the Symptoms of GERD (FSSG) total score
Time frame: Baseline to Week 6
Short Form-36 Health Survey (SF-36) total score
Time frame: Baseline to Week 6
Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline to Week 6
Beck Depression Inventory (BDI) total score
Time frame: Baseline to Week 6
Postural Alignment Parameters (PostureScreen Mobile)
Time frame: Baseline to Week 6
Y-Balance Test reach distances
Time frame: Baseline to Week 6
Anthropometric circumference measurements
Time frame: Baseline to Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Daily Activity (No Exercise Intervention) and Supervised Clinical Pilates Exercise Training in people with Pilates Exercise and Gastro Esophageal Reflux, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.