Polycystic Ovarian Syndrome (PCOS)SSAETNCT07157371
Effects of Aerobic Exercise Training Program in Females With Insulin Resistant Polycystic Ovarian Syndrome
A study testing Supervised structured aerobic exercise training and Walk in people with Polycystic Ovarian Syndrome (PCOS) and Aerobic Exercise, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Aerobic Exercise, Walking
- What is being tested?
- Supervised structured aerobic exercise training and Walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on BDNF levels in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on mental health (stress, depression, anxiety) in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on BMI in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on menstrual irregularity in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Aerobic fitness in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on androgens level in PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Lipid accumulation product in PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Glycemic control in PCOS.
Read the detailed description
Polycystic ovarian syndrome is a very common systemic disease consisting of hormone problem for women of childbearing age. Women with PCOS may not ovulate, have high levels of androgens, and have many small cysts on the ovaries. PCOS can cause missed or irregular menstrual periods, excess hair growth, acne, infertility, and weight gain. BDNF is linked with exercise and its receptors are also in ovaries. Hence, if the levels of BDNF falls below average then it plays an important role in hyperandrogenism and this often accompanied with lack of physical activity. Another factor, lipid accumulation product is closely related to glucose intolerance and wight gain which eventually gives rise to hyperandrogenism and it eventually affects the quality of life of females with polycystic ovarian syndrome.
It will be a randomized controlled trial. Convenient sampling technique would be used.
Inclusion criteria would be females of age 18-35 years, insulin resistant polycystic ovarian syndrome, pre-diagnosed, married and un married both, diabetic \& nulliparous females.
Exclusion criteria would be post pill, Inflammatory \& Adrenal PCOS, any psychological disease or disorder, any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, renal tumor, 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 \& Pregnant females.
Patients enrolled in the study will be divided randomly by even odd method. (Group A=30) will be given the Supervised Structured Aerobic Exercise Treatment Program for 12 weeks along with their normal routine medications given to them by their gynecologist.
(Group B=30) will have the conventional treatment of only the routine medications given by their gynecologist and brisk walk plan. Assessment of variables would be taken from both groups at baseline, 12 weeks and 25 weeks of intervention. 2 ml of blood would be taken through syringe and plasma would be tested for BDNF levels through ELISA, Androgens level through Free Androgen Index and quality of Life through Polycystic Ovarian Syndrome Quality of Life Questionnaire (PCOSQ). Aerobic fitness through Canadian fitness test and VO2max. Glycated hemoglobin would be tested for glucose intolerance through HbA1c test.
Keywords: Polycystic ovary syndrome, Poly cystic ovarian syndrome, sclerocystic ovaries, aerobic fitness, aerobic exercise, supervised, hyperandrogenism, PCOS, SHBG, testosterone, Quality of life.
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.
STUDY GROUPS:
Group 1: (Experimental Group n=30) Conventional Drugs treatment of PCOS advised by the medical specialist along with the Supervised Structured Aerobic Exercise Training program (SSAET) for 25 weeks.(29) Speed of the treadmill will be calculated and maintained at 60 to 70% of MHR in each session with progression of duration and inclination only. The intervention in experimental group would be divided into 5 phases of 5 weeks duration each.
DURATION OF EXERCISE SESSION
The patients in experimental group would be treated for a single session per day, at 3 days per week for 25 weeks. The details of each phase are given below:
Phase-1: In first phase the duration of each session would be 10 minutes and the total duration of exercise will be 30 minutes per week.
Phase-2: In the second phase the duration of a single session would be 20 minutes and duration21 of exercise per week will be 60 minutes.
Phase-3: In the third phase the duration of a single session would be 30 minutes and the total duration of exercise per week will be 90 minutes.
Phase-4: In the fourth phase the duration of each phase would be 40 minutes and the total duration of exercise per week will be 120 minutes.
Phase-5: In the last phase and final phase the duration of a single session would be 50 minutes and the total duration of exercise will be 150 minutes per week, as recommended by the American heart Association (AHA).
INCLINATION OF TREADMILL WALKING RAMP WITH GROUND (30) Phase-1: Normal Phase-2: 3 degrees Phase-3: 6 degrees Phase-4: 9 degrees Phase-5: 12 degrees Intensity of progression would be measured by the subject's Borgs rate of perceived exertion (RPE) according to the 15-point Borg Scale as per individual load.
Warm up and cool down protocol:
- Without treadmill: warm up protocol involves breathing exercises, Stretching exercises (pectoralis major, triceps, biceps, hamstrings \& calf stretch) and cool down exercises as ankle-toe movements of 5-10 min duration.
- On tread mill: the warming-up phase, which consisted in walking on the treadmill for 5 minutes at low intensity (30% of MHR), at a 0% slope before the actual phase, and the cooling phase, which consist of in walking on the treadmill for 5 minutes at low intensity (30% of MHR) at 0% slope in each session. The MHR would be calculated according to the equation (HR= 220-age).
Group 2: (Control Group n=30) Conventional Drugs treatment of PCOS advised by the medical specialist along with the simple sustained brisk walk advised at a self-selected brisk pace described as "faster than normal walking but a pace that could be sustained for at least 20 min." Subjects would be instructed to complete at least three walks per week, each walk of 20 to 60 min duration.
TOOLS:
- Modified polycystic ovarian syndrome Quality of Life Questionnaire (MPCOSQ)- Quality of life
- MIQ (Menstrual Irregularity Questionnaire)- Menstrual irregularity
- Women's weight in kilograms divided by the square of height in meters- BMI
- Aerobic fitness- I. Canadian home fitness test, bench test from 8cm for 3 min 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
- BDNF levels- ELISA
- 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)
- Mental health- (Stress, depression \& Anxiety) by DASS
- Lipid Accumulation Product -Triglycerides test and waist circumference The LAP would be calculated as [waist circumference (centimeters) - 58] × [triglycerides (millimoles per liter)]
- Glycemic control-HbA1c levels (Pre-diabetic condition as HbA1c 5.7-6.4% according to American Diabetic Association)
- Being tested
- Supervised structured aerobic exercise training, Walk
- Keywords
- Insulin resistant, Supervised, aerobic exercise, SSAET, PCOS, metabolic syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised structured aerobic exercise trainingOther
Also called Aerobic exercises
Supervised structured aerobic exercise plan will be conducted in gym by the physiotherapist
WalkOther
Females with PCOS will be instructed to do a walk at home with medications
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS)
Mental Health (Stress, depression \& Anxiety) by DASS 21
Scoring Process:
- Sum the scores for each subscale: Add the scores for the 7 items within each subscale (Depression, Anxiety, and Stress).
- Multiply by 2: Multiply the sum of each subscale by 2 to get the final score for each area (Depression, Anxiety, and Stress).
- 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 weeks and 25 weeks
ELISA
BDNF levels
Measured: 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)
Measured: 12 weeks and 25 weeks
Secondary outcomes (3)
HOMA-IR for Glycemic control
The HOMA-IR score is calculated using your fasting glucose and fasting insulin levels:
HOMA-IR = (Fasting Glucose x Fasting Insulin) / 22.5
Measured: 12 weeks and 25 weeks
Lipid Accumulation Product
Triglycerides test and waist circumference The LAP would be calculated as [waist circumference (centimeters) - 58] × [triglycerides (millimoles per liter)]
Measured: 12 weeks and 25 weeks
BMI
Women's weight in kilograms divided by the square of height in meters
Measured: 12 weeks and 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Riphah International 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzna Munir, Riphah International University
- Investigators
- Muzna Munir, ppdpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157371
- Sponsor's protocol ID
- REC/RCR/ & AHS/23/1103
- Acronym
- SSAET
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28811774
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07157371
- Acronym / sponsor ID
- SSAET / REC/RCR/ & AHS/23/1103
- Keywords
- Insulin resistant, Supervised, aerobic exercise, SSAET, PCOS, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Sep 2025 (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.
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.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on BDNF levels in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on mental health (stress, depression, anxiety) in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on BMI in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on menstrual irregularity in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Aerobic fitness in women with PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on androgens level in PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Lipid accumulation product in PCOS.
- To determine the effect of Supervised Structured Aerobic Exercise Training Program on Glycemic control in PCOS.
Detailed description
Polycystic ovarian syndrome is a very common systemic disease consisting of hormone problem for women of childbearing age. Women with PCOS may not ovulate, have high levels of androgens, and have many small cysts on the ovaries. PCOS can cause missed or irregular menstrual periods, excess hair growth, acne, infertility, and weight gain. BDNF is linked with exercise and its receptors are also in ovaries. Hence, if the levels of BDNF falls below average then it plays an important role in hyperandrogenism and this often accompanied with lack of physical activity. Another factor, lipid accumulation product is closely related to glucose intolerance and wight gain which eventually gives rise to hyperandrogenism and it eventually affects the quality of life of females with polycystic ovarian syndrome.
It will be a randomized controlled trial. Convenient sampling technique would be used.
Inclusion criteria would be females of age 18-35 years, insulin resistant polycystic ovarian syndrome, pre-diagnosed, married and un married both, diabetic \& nulliparous females.
Exclusion criteria would be post pill, Inflammatory \& Adrenal PCOS, any psychological disease or disorder, any systemic disease other than PCOS (cushing syndrome, thyroid dysfunction, renal tumor, 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 \& Pregnant females.
Patients enrolled in the study will be divided randomly by even odd method. (Group A=30) will be given the Supervised Structured Aerobic Exercise Treatment Program for 12 weeks along with their normal routine medications given to them by their gynecologist.
(Group B=30) will have the conventional treatment of only the routine medications given by their gynecologist and brisk walk plan. Assessment of variables would be taken from both groups at baseline, 12 weeks and 25 weeks of intervention. 2 ml of blood would be taken through syringe and plasma would be tested for BDNF levels through ELISA, Androgens level through Free Androgen Index and quality of Life through Polycystic Ovarian Syndrome Quality of Life Questionnaire (PCOSQ). Aerobic fitness through Canadian fitness test and VO2max. Glycated hemoglobin would be tested for glucose intolerance through HbA1c test.
Keywords: Polycystic ovary syndrome, Poly cystic ovarian syndrome, sclerocystic ovaries, aerobic fitness, aerobic exercise, supervised, hyperandrogenism, PCOS, SHBG, testosterone, Quality of life.
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.
STUDY GROUPS:
Group 1: (Experimental Group n=30) Conventional Drugs treatment of PCOS advised by the medical specialist along with the Supervised Structured Aerobic Exercise Training program (SSAET) for 25 weeks.(29) Speed of the treadmill will be calculated and maintained at 60 to 70% of MHR in each session with progression of duration and inclination only. The intervention in experimental group would be divided into 5 phases of 5 weeks duration each.
DURATION OF EXERCISE SESSION
The patients in experimental group would be treated for a single session per day, at 3 days per week for 25 weeks. The details of each phase are given below:
Phase-1: In first phase the duration of each session would be 10 minutes and the total duration of exercise will be 30 minutes per week.
Phase-2: In the second phase the duration of a single session would be 20 minutes and duration21 of exercise per week will be 60 minutes.
Phase-3: In the third phase the duration of a single session would be 30 minutes and the total duration of exercise per week will be 90 minutes.
Phase-4: In the fourth phase the duration of each phase would be 40 minutes and the total duration of exercise per week will be 120 minutes.
Phase-5: In the last phase and final phase the duration of a single session would be 50 minutes and the total duration of exercise will be 150 minutes per week, as recommended by the American heart Association (AHA).
INCLINATION OF TREADMILL WALKING RAMP WITH GROUND (30) Phase-1: Normal Phase-2: 3 degrees Phase-3: 6 degrees Phase-4: 9 degrees Phase-5: 12 degrees Intensity of progression would be measured by the subject's Borgs rate of perceived exertion (RPE) according to the 15-point Borg Scale as per individual load.
Warm up and cool down protocol:
- Without treadmill: warm up protocol involves breathing exercises, Stretching exercises (pectoralis major, triceps, biceps, hamstrings \& calf stretch) and cool down exercises as ankle-toe movements of 5-10 min duration.
- On tread mill: the warming-up phase, which consisted in walking on the treadmill for 5 minutes at low intensity (30% of MHR), at a 0% slope before the actual phase, and the cooling phase, which consist of in walking on the treadmill for 5 minutes at low intensity (30% of MHR) at 0% slope in each session. The MHR would be calculated according to the equation (HR= 220-age).
Group 2: (Control Group n=30) Conventional Drugs treatment of PCOS advised by the medical specialist along with the simple sustained brisk walk advised at a self-selected brisk pace described as "faster than normal walking but a pace that could be sustained for at least 20 min." Subjects would be instructed to complete at least three walks per week, each walk of 20 to 60 min duration.
TOOLS:
- Modified polycystic ovarian syndrome Quality of Life Questionnaire (MPCOSQ)- Quality of life
- MIQ (Menstrual Irregularity Questionnaire)- Menstrual irregularity
- Women's weight in kilograms divided by the square of height in meters- BMI
- Aerobic fitness- I. Canadian home fitness test, bench test from 8cm for 3 min 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
- BDNF levels- ELISA
- 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)
- Mental health- (Stress, depression \& Anxiety) by DASS
- Lipid Accumulation Product -Triglycerides test and waist circumference The LAP would be calculated as [waist circumference (centimeters) - 58] × [triglycerides (millimoles per liter)]
- Glycemic control-HbA1c levels (Pre-diabetic condition as HbA1c 5.7-6.4% according to American Diabetic Association)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group- PCOS | Experimental | Other: Supervised structured aerobic exercise training25 weeks of supervised structured aerobic exercise treatment program will be applied on the females with PCOS in the gym setting. |
| Second group- PCOS | Active comparator | Other: Walkwalk will be asked for these patients and their feedback will be taken through cell phone |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Supervised structured aerobic exercise trainingAlso: Aerobic exercisesSupervised structured aerobic exercise plan will be conducted in gym by the physiotherapist | Other | Interventional group- PCOS |
| WalkFemales with PCOS will be instructed to do a walk at home with medications | Other | Second group- PCOS |
Primary outcome
Depression Anxiety Stress Scale (DASS)
Time frame: 12 weeks and 25 weeks
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.
Polycystic ovarian syndrome Quality of Life Questionnaire (PCOSQOL)
Time frame: 12 weeks and 25 weeks
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.
MIQ (Menstrual Irregularity Questionnaire)
Time frame: 12 weeks and 25 weeks
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.
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
Time frame: 12 weeks and 25 weeks
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
ELISA
Time frame: 12 and 25 weeks
BDNF levels
Androgens level
Time frame: 12 weeks and 25 weeks
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)
3 secondary outcomes
HOMA-IR for Glycemic control
Time frame: 12 weeks and 25 weeks
Lipid Accumulation Product
Time frame: 12 weeks and 25 weeks
BMI
Time frame: 12 weeks and 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 28811774Shakil-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.
- Intervention being used on the other metabolic disorderLink provided by the sponsor.
- Aerobic general exercises were applied for 12 weeks only to see the results on inflammatory markers.Link provided by the sponsor.
- Relation of abnormal BDNF levels and PCOSLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Muzna Munir, ppdpt principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised structured aerobic exercise training and Walk in people with Polycystic Ovarian Syndrome (PCOS) and Aerobic Exercise, run by Riphah International University at 1 site in Pakistan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression Anxiety Stress Scale (DASS) (time frame: 12 weeks and 25 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157371, which also lists 1 linked publication.
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 5 Sep 2025.