High-Intensity Interval Training On Women With Polycystic Ovary Syndrome.

NCT04942366 | Completed Results

• 1 other identifier: Mubarra Rao
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. It will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).

Conditions

Polycystic Ovary Syndrome

Keywords

High intensity interval training; Exercise; Polycystic Ovary Syndrome; Physical Therapy; Strength training; Testosterone; Physical activity

Outcome Measures

Primary Outcomes (3)

• Serum Testosterone

  Levels of serum testosterone

  0 weeks to 12-weeks

• Body Fat Percentage

  Using skinfold method (body caliper)

  0-week to 12-weeks

• Physical Activity

  International physical activity questionnaire

  0-week to 12-weeks

Study Arms (2)

HIIT Group

EXPERIMENTAL

High intensity interval training will be performed thrice a week using a treadmill.

Other: High intensity interval training

ST Group

ACTIVE COMPARATOR

Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum).

Other: Strength training

Interventions

High intensity interval training OTHER

HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).

Also known as: HIIT

HIIT Group

Strength training OTHER

Strength training will be performed thrice a week, each session will consist of eight dynamic drills.

ST Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI:
• Overweight: 23-24.9 kg/m2.
• Obese: greater than or equal to 25 kg/m2 .
• Diagnosed and referred PCO patients to the rehabilitation unit would be selected for the study.
• Aged 18-40.
• High serum testosterone level: normal range 6-86 ng/dl.

You may not qualify if:

• On-going pregnancy.
• Any cardiovascular complication.
• Any other endocrine disorder
• Any musculoskeletal condition that hinders in performing the exercise training protocol.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Shamim clinic

Karachi, Sindh, 75340, Pakistan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Motor Activity

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Mubarra Rao
• Organization: Ziauddin University

mubarrar@gmail.com

03343088915

Study Officials

• Mubarra Rao

  Ziauddin University

  PRINCIPAL INVESTIGATOR

• Amna Amir Khan

  Ziauddin University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: While the exercise protocol will be explained to the participant and care giver however the they will be blinded regarding which is intervention group or control group and which exercise is the main interventional exercise will not be disclosed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups in which participants are randomly allocated while both groups will perform warm up and cool down session, Group A will perform High intensity interval training and Group B will perform strength training exercises.

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 28, 2021
• Study Start: April 12, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)