Polycystic Ovary SyndromeNCT06198348
Aerobic Training With and Without Resistance Training in Polycystic Ovarian Syndrome
A study testing Aerobic Exercise and Aerobic Exercises with Resistance training in people with Polycystic Ovary Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Aerobic Exercise and Aerobic Exercises with Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.
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.
Read the detailed description
A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Aerobic Exercise, Aerobic Exercises with Resistance training
- Keywords
- Polycystic ovarian syndrome, Quality of life, Waist to Hip Ratio, Aerobic Exercise, Resistance Training
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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 Exercises with Resistance trainingOther
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:
- Leg press (dual leg press): Leg press targets the Glutes "Quadriceps or quads .but they also work your "Hamstrings".
- Crunches: Crunches Target the abdominal muscles specifically rectus abdominis and obliques.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Aerobic Exercises with Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faiza Taufiq, PPDPT, Principal investigator, Riphah International University, Senior Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198348
- Sponsor's protocol ID
- S22C14G92023
- Status last verified
- Apr 2024
- First submitted
- 26 Dec 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.
- ClinicalTrials.gov ID
- NCT06198348
- Acronym / sponsor ID
- S22C14G92023
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovarian syndrome, Quality of life, Waist to Hip Ratio, Aerobic Exercise, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 Jan 2024 (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.
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.
Detailed description
A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (Control Group) | Other | Other: Aerobic ExerciseGroup 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 |
| Aerobic exercise with resistance training (Experimental Group) | Experimental | Other: Aerobic Exercises with Resistance trainingGroup 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Aerobic ExerciseTreatment 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. | Other | Aerobic Exercise (Control Group) |
| Aerobic Exercises with Resistance trainingThese 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 | Other | Aerobic exercise with resistance training (Experimental Group) |
Primary outcome
SF-36 Questionnaire
Time frame: 8 weeks
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.
Self-administered PCOSQ
Time frame: 8 weeks
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.
Measuring Tape
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
Faiza Taufiq, PPDPT principal investigator
Riphah International University, Senior Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Aerobic Exercises with Resistance training in people with Polycystic Ovary Syndrome, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SF-36 Questionnaire (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.