NCT06198348

Brief Summary

Polycystic ovary syndrome (PCOS) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. It has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. PCOS is linked to Psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. Approximately 75% of people with PCOS have a fat accumulation in the central area of the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

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

March 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

December 26, 2023

Last Update Submit

April 18, 2024

Conditions

Keywords

Polycystic ovarian syndromeQuality of lifeWaist to Hip RatioAerobic ExerciseResistance Training

Outcome Measures

Primary Outcomes (3)

  • SF-36 Questionnaire

    QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements.validity of SF-36 Questionnaire is 0.90 Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale.

    8 weeks

  • Self-administered PCOSQ

    All the participants filled up the self-administered PCOSQ. PCOS Questionnaire has 26 items divided into 5 domains: emotions (8 items), body hair (5 items), weight (5 items), infertility (4 items), and menstrual problems (4 items). Each question is associated with a 7point scale in which 7 represents optimal function and 1 represents the poorest Function. PCOSQ dimensions were internally reliable with Cronbach's a scores ranging from 0.70 to 0.97.

    8 weeks

  • Measuring Tape

    Waist circumference (WC) was measured with the participant in the standing position, with arms at the side of the body, feet together, and with a relaxed abdomen. For WC, a horizontal measurement was obtained on the narrower part of the dorsum (above the navel and below the xiphoid process. Hip circumference (HC) was measured using the same positioning, as the region with the largest circumference of the buttocks. Waist-to-hip ratio (WHR) was measured by dividing the WC value by the HC value

    8 weeks

Study Arms (2)

Aerobic Exercise (Control Group)

OTHER

Group A will receive Aerobic exercise plan. The treatment will be given with the frequency of 3 times per week for 8 weeks. Treatment sessions will be of 30 minutes with short resting intervals

Other: Aerobic Exercise

Aerobic exercise with resistance training (Experimental Group)

EXPERIMENTAL

Group B will receive aerobic and resistance exercise plan. The frequency of treatment will be as same as that of aerobic exercise program i.e. 3 times a week for 8 weeks. Treatment sessions will be of 45 minutes with short resting intervals

Other: Aerobic Exercises with Resistance training

Interventions

Treatment Protocol to Group A It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 30 minutes. It will include warm up phase, active phase and cool down phase Warm-up phase: In which each participant will walk at 80 m/min at for 5 min. Active phase: Brisk walking or treadmill: In which each participant will perform brisk walking for 15 mints initially. After that gradually duration of brisk walking will increase.

Aerobic Exercise (Control Group)

These groups will perform these exercises: Aerobic exercise +resistance exercises Exercise Session: 3 days per week Time of exercise session: 30-45 min After following protocol of aerobic exercise as mentioned above the subjects will perform resistance exercises. These Exercises will perform: 1. Leg press (dual leg press): Leg press targets the Glutes "Quadriceps or quads .but they also work your "Hamstrings". 2. Crunches: Crunches Target the abdominal muscles specifically rectus abdominis and obliques. 3. Squats: Squats targets the adductor muscles of the hip, glutes and rectus abdominis muscle Leg Extension Total Exercise plan for 12 weeks: 1-2 weeks: Repitations: 10-15 times No of sets: 1 set Resistance: minimum 3-4 weeks: Repitations: 10-15 times No of sets: 2 set Resistance: moderate 5-6 weeks: Repitations: 15-16 times No of sets: 2 set Resistance: moderate 7-8 weeks: Repitations: 15-16 times No of sets: 2 set

Aerobic exercise with resistance training (Experimental Group)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPolycystic Ovary Syndrome only occurs in females.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40yrs
  • Waist to hip ratio \>87(20)
  • Women who are diagnosed according to Rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21)
  • Female who physically able to performs exercise

You may not qualify if:

  • Women who are smoking and using drugs for depression.
  • Married women
  • Women with other pathological conditions like diabetes and thyroid diseases.
  • Females who are not able to perform resistant exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Officials

  • Faiza Taufiq, PPDPT

    Riphah International University, Senior Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

March 15, 2023

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations