Effects of Aerobic Exercise Training Program in Females With Insulin Resistant Polycystic Ovarian Syndrome

NCT07157371 | Active Not Recruiting DMC

• 1 other identifier: REC/RCR/ & AHS/23/1103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Design: RCT Randomized Clinical Trial Non Probability Convenient Sampling Technique Duration of treatment: 25 weeks 2 groups; (group A=30) SSAET +Normal routine medication+ Normal Dietary Plan , Other group (Group B=30) with normal routine medication + Normal Dietary Plan. Patients will be enrolled in experimental group according to speeds test. HYPOTHESIS: Alternate hypothesis: There is difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome. Null Hypothesis: There is no difference on the effects of Supervised Structured Aerobic Exercise Training Program on serum BDNF, androgens level, menstrual irregularity and quality of life in females with insulin resistant polycystic ovarian syndrome. OBJECTIVES: To determine the effects of Supervised Structured Aerobic Exercise Training Program on quality of life in women with PCOS. 2\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BDNF levels in women with PCOS. 3\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on mental health (stress, depression, anxiety) in women with PCOS. 4\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on BMI in women with PCOS. 5\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on menstrual irregularity in women with PCOS. 6\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Aerobic fitness in women with PCOS. 7\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on androgens level in PCOS. 8\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Lipid accumulation product in PCOS. 9\. To determine the effect of Supervised Structured Aerobic Exercise Training Program on Glycemic control in PCOS.

Conditions

Polycystic Ovarian Syndrome (PCOS); Aerobic Exercise; Walking

Keywords

Insulin resistant; Supervised; aerobic exercise; SSAET; PCOS; metabolic syndrome

Outcome Measures

Primary Outcomes (6)

• Depression Anxiety Stress Scale (DASS)

  Mental Health (Stress, depression \& Anxiety) by DASS 21 Scoring Process: 1. Sum the scores for each subscale: Add the scores for the 7 items within each subscale (Depression, Anxiety, and Stress). 2. Multiply by 2: Multiply the sum of each subscale by 2 to get the final score for each area (Depression, Anxiety, and Stress). 3. Interpret the scores: The resulting scores are then interpreted using the provided severity levels for each subscale. Severity Levels: The DASS-21 provides severity levels for each subscale: Depression: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+). Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+). Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+). \> Higher the scores means more severity and less healthy.

  12 weeks and 25 weeks

• Polycystic ovarian syndrome Quality of Life Questionnaire (PCOSQOL)

  This is a tool to measure quality of life in females with Polycystic Ovarian syndrome. There are total 35 Questions in it. Scoring: Summate each item to give a total score. A low score represents that a lower quality of life, a higher score represents a lesser to no impact on quality of life.

  12 weeks and 25 weeks

• MIQ (Menstrual Irregularity Questionnaire)

  Measures menstrual irregularity The MIQ is a 6-point questionnaire, and the total score reflects the overall impact of heavy menstrual bleeding on the woman's life. Higher scores indicate a greater negative impact of heavy menstrual bleeding on the woman's quality of life. The MIQ helps healthcare professionals understand the severity of the problem and tailor treatment accordingly.

  12 weeks and 25 weeks

• 3 min bench step test II. Indirect estimation of VO2 max by formula VO2 max (walking) = (0.2 x speed of treadmill) + (0.9 x speed x treadmill grade) + 3.5

  To measure Aerobic fitness. YMCA 3-minute Bench Step Test: You step up and down on a 30 cm (12-inch) step for three minutes at a consistent pace, and your heart rate is measured afterward to estimate fitness for 1 minute through carotid artery. The more fit you are, the lower your recovery heart rate will be, meaning a lower number is a better score. Compare to Charts: Use your age and gender to find the appropriate fitness rating chart, such as the YMCA charts. Determine Your Level: The chart will show whether your 1-minute heart rate falls into categories like excellent, good, above average, average, or below average fitness. YMCA FEMALES Scoring: Excellent \<109 Above Average 110 - 117 Average 118 - 134 Below Average 135-137 Poor \>137

  12 weeks and 25 weeks

• ELISA

  BDNF levels

  12 and 25 weeks

• Androgens level

  Serum SHBG will be measured by coated-tube immunoradiometric assay using commercial kits. Testosterone will be measured by RIA using commercial enzymatic kits. Free androgen index (FAI) will be calculated as testosterone/SHBG × 100. Clinical hyperandrogenism (a score of 6 or higher on the modified Ferriman-Gallwey scale)

  12 weeks and 25 weeks

Secondary Outcomes (3)

• HOMA-IR for Glycemic control

  12 weeks and 25 weeks

• Lipid Accumulation Product

  12 weeks and 25 weeks

• BMI

  12 weeks and 25 weeks

Study Arms (2)

Interventional group- PCOS

EXPERIMENTAL

25 weeks of supervised structured aerobic exercise treatment program will be applied on the females with PCOS in the gym setting.

Other: Supervised structured aerobic exercise training

Second group- PCOS

ACTIVE COMPARATOR

walk will be asked for these patients and their feedback will be taken through cell phone

Other: Walk

Interventions

Supervised structured aerobic exercise training OTHER

Supervised structured aerobic exercise plan will be conducted in gym by the physiotherapist

Also known as: Aerobic exercises

Interventional group- PCOS

Walk OTHER

Females with PCOS will be instructed to do a walk at home with medications

Second group- PCOS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: females only who are diagnosed by the gynecologist with polycystic ovarian syndrome according to Rotterdum criteria of diagnosing PCOS.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 To 35 years Females.
• Insulin resistant PCOS type.
• Already Diagnosed patients form gynecological department according to the Rotterdam criteria.
• Both Married and unmarried females.
• Nulliparous females.

You may not qualify if:

• Post pill PCOS, Inflammatory PCOS \& Adrenal PCOS
• Any psychological disease or disorder
• Any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, etc)
• Orthopedic conditions (including fracture, dislocation, etc)
• Any surgery in past 6 months.
• Involved in any other exercise regimen at the same time.
• Having any specialized diet plan.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Sculpture Gym

Lahore, 53710, Pakistan

Location

Related Publications (1)

• Shakil-Ur-Rehman S, Karimi H, Gillani SA. Effects of supervised structured aerobic exercise training program on fasting blood glucose level, plasma insulin level, glycemic control, and insulin resistance in type 2 diabetes mellitus. Pak J Med Sci. 2017 May-Jun;33(3):576-580. doi: 10.12669/pjms.333.12023.

  PMID: 28811774 RESULT

Related Links

• Intervention being used on the other metabolic disorder
• Aerobic general exercises were applied for 12 weeks only to see the results on inflammatory markers.
• Relation of abnormal BDNF levels and PCOS

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Interventions

Exercise; Walking

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; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion

Study Officials

• Muzna Munir, ppdpt

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: September 5, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)