NCT07875400

Brief Summary

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is associated with obesity, insulin resistance, poor physical fitness, and reduced quality of life. This randomized controlled trial will examine how High intensity Interval Training (HIIT) and Mat Pilates effect body composition, physical fitness, and quality of life in women diagnosed with Polycystic Ovary Syndrome (PCOS) . A total of 60 participants will be randomly assigned to one of three groups; HIIT, Mat Pilates, or a control group. Each intervention will run for eight weeks, with body composition, physical fitness, and quality of life measured both before and after the program to evaluate the comparative effectiveness of the two exercise intervention.

Trial Health

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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 16, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

8 months

First QC Date

September 16, 2026

Last Update Submit

October 11, 2026

Conditions

Keywords

PPCOSHigh Intensity Interval TrainingHIITMat PilatesBody CompositionPhysical FitnessWomen with PCOSExercise TrainingMenstrual Irregularity

Outcome Measures

Primary Outcomes (3)

  • Change in Body Composition

    Change from baseline in body weight, measured in kilograms using a weighing scale.

    Baseline and post-intervention (Week 8).

  • Body circumference

    Change from baseline in body circumference (neck, chest, waist, hips, upper arm, thigh, and calf), measured in centimeters using a measuring tape.

    Baseline and post-intervention (Week 8)

  • Change in Skinfold Thickness

    Change from baseline in skinfold thickness, measured in millimeters using a skinfold caliper.

    Baseline and post-intervention (Week 8)

Secondary Outcomes (9)

  • Change in Quality of Life (PCOSQ score)

    Baseline and post-intervention (e.g., Week 8)

  • Change in 6-Minute Walk Test Distance

    Baseline and post-intervention (Week 8).

  • Change in Curl-Up Repetitions

    Baseline and post-intervention (Week 8)

  • Change in Bird-Dog Test Performance

    Baseline and post-intervention (Week 8)

  • Change in Wall-Squat Hold Time.

    Baseline and post-intervention (Week 8).

  • +4 more secondary outcomes

Study Arms (3)

Arm 1: HIIT Group

EXPERIMENTAL

Arm Description: HIIT Group: Participants will undergo a structured high-intensity interval training (HIIT) program for 8 weeks, consisting of repeated bouts of high-intensity exercise followed by active recovery periods. Sessions will be conducted under supervision and will progressively increase in intensity according to participants tolerance and fitness level.

Other: High-Intensity Interval Training (HIIT)

Arm 2: Mat Pilates Group

EXPERIMENTAL

Mat Pilates Group: Participants will undergo a structured mat Pilates program for 8 weeks, consisting of supervised Pilates exercises focusing on core strength, muscular endurance, flexibility, posture, balance, and controlled breathing. Exercise intensity will be progressively increased according to participants' tolerance and fitness level.

Other: Mat Pilates group

Control

OTHER

Participants will receive basic mobility exercises and general daily-life activity guidance throughout the 8-week study period.

Other: General mobility exercises

Interventions

Participants will undergo a supervised 8-week High-Intensity Interval Training (HIIT) program, consisting of repeated bouts of high-intensity exercises alternated with active recovery periods. Each session will include a warm-up, HIIT exercises, and cool-down. Exercise intensity and duration will be progressively increased according to participants' tolerance and fitness level.

Arm 1: HIIT Group

Participants will undergo a supervised 8-week Mat Pilates program, consisting of structured Pilates exercises focusing on core strength, muscular endurance, flexibility, posture, balance, and controlled breathing. Each session will include a warm-up, Pilates exercises, and cool-down. Exercise intensity and difficulty will be progressively increased according to participants' tolerance and fitness level.

Arm 2: Mat Pilates Group

Participants will receive basic mobility exercises and general daily-life activity guidance throughout the 8-week study period.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women diagnosed with Polycystic Ovary Syndrome (PCOS) as per Rotterdam Criteria.
  • Sedentary or low physical activity level.
  • Willing to participate and provide informed consent.

You may not qualify if:

  • Pregnancy or planning pregnancy
  • Diagnosed endocrine disorders (e.g., thyroid disorders, Cushing syndrome)
  • Diagnosed cardiovascular, musculoskeletal, or metabolic diseases.
  • Recent pelvic or abdominal surgery.
  • Currently on structured exercise program or hormonal therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeMenstruation Disturbances

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aneeqa Farooq

    Riphah International University, Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a three-arm, parallel-group randomized controlled trial. Eligible participants will be randomly allocated in a 1:1:1 ratio to one of three groups: (1) High-Intensity Interval Training (HIIT), (2) Mat Pilates, or (3) a control group. Each group will receive its assigned intervention (or standard care, for the control group) concurrently over the same study duration, with outcomes assessed at baseline and post-intervention. Participants in each arm will not cross over to another intervention during the study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2026

First Posted

October 15, 2026

Study Start (Estimated)

October 20, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations