Polycystic Ovary SyndromeNCT06302166
Effects of HICT and Intermittent Fasting on PCOS
A study testing High Intensity Circuit training (HICT), Intermittent Fasting (IF) and Combination of HICT and IF in people with Polycystic Ovary Syndrome and PCO, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, PCO
- What is being tested?
- High Intensity Circuit training (HICT), Intermittent Fasting (IF) and Combination of HICT and IF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Mar 2024to 1 Jul 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unmarried females
- Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:
- PCOM on US
- Ovulatory dysfunction
- Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8)
- Not engaged in any regular lifestyle intervention for \<3 Months prior to inclusion
Who cannot join
- Use of Estrogen, Progestin or combination.
- Taking medications or supplements for Insulin resistance \< 3 months prior to the inclusion
- Type I or II DM
- Hypo/hyperthyroidism
- BMI ≥27 (Obese according to BMI Asia)
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Bilal Hospital
Rawalpindi, Punjab Province, 44000
Sarah Ehsan, PP-DPT, 03217770829, sarah.ehsaan@riphah.edu.pk
Hafsa Javed, DPT
- Recruiting
Noor Clinic
Rawalpindi, Punjab Province, 44000
Sarah Ehsan, PP-DPT, 00923217770829, sarah.ehsaan@riphah.edu.pk
Hafsa Javed, DPT
About this study
Official title: Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome
The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.
Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.
- Conditions
- Polycystic Ovary Syndrome, PCO
- Being tested
- High Intensity Circuit training (HICT), Intermittent Fasting (IF), Combination of HICT and IF
- Keywords
- PCO, Polycystic Ovary syndrome, Females, Body Image concerns
- 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.
High Intensity Circuit training (HICT)Other
High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided.
Intermittent Fasting (IF)Other
Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol.
Combination of HICT and IFOther
The participants will follow both HICT and IF for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity circuit training (HICT) | Active comparator | For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity. Receives: Other: High Intensity Circuit training (HICT) |
| Intermittent fasting (IF) | Active comparator | For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8). Receives: Other: Intermittent Fasting (IF) |
| Combination of HICT and IF | Active comparator | The group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating. Receives: Other: Combination of HICT and IF |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCOS Morphology
Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .
Measured: 8th Week
Secondary outcomes (3)
Anthropometrics
Changes from baseline Weight (kg) will be measured by weight scale while height (ft) will be measured by stadiometer. BMI will be calculated by dividing your weight in kilograms (kg) by your height in meters squared (m 2 ). Waist Circumference (WC) will be measured in centimeters, between the costal margin and the pelvic brim, and Hip Circumference (HC) will be measured in cm at the level of the symphysis pubis by inches tape.
Measured: 8th Week
Clinical Hyperandrogenism
Changes from baseline Modified Ferriman Gallwey (mFG) score will be used to assess the hirsutism as a measure of clinical hyperandrogenism.
Measured: 8th Week
Body Image concerns
Changes from baseline Body Image concerns will be measured using The BSQ which is a self-reported measurement of the body shape concerns designed for women to measure concerns about body image problems.
Measured: 8th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Mar 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302166
- Sponsor's protocol ID
- REC/MS-PT/01720
- Status last verified
- May 2024
- First submitted
- 4 Mar 2024
- Last updated
- 21 May 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Circuit Training and Intermittent Fasting on Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06302166
- Acronym / sponsor ID
- REC/MS-PT/01720
- Conditions
- Polycystic Ovary Syndrome, PCO
- Keywords
- PCO, Polycystic Ovary syndrome, Females, Body Image concerns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 8 Mar 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.
The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS.
Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity circuit training (HICT) | Active comparator | Other: High Intensity Circuit training (HICT)For the group allocated with exercise, high intensity circuit training (HICT) of three supervised sessions per week for 20-30 mins will be given. HICT commenced after 10 mins low to moderate intensity warm up and after completing session ended with 10 mins cool down. Intensity of exercise will be measured on borg rating of perceived exertion (RPE). Perceived exertion is how hard you feel like your body is working. Although this is a subjective measure your exertion rating based on a 0 to 10 modified borg rating scale may provide a fairly good estimate of your actual heart rate during physical activity. 0 perceiving "no exertion at all" to 10 perceiving a "maximal exertion" of effort. A moderate intensity activity will be at 3-5 perceiving "somewhat hard", similarly 6-10 will be perceived as high intensity activity. |
| Intermittent fasting (IF) | Active comparator | Other: Intermittent Fasting (IF)For the group allocated with intermittent fasting, a time restricted feeding (TRF) methodology will be administered. The Fasting protocol will begin with a 12-hour eating window (12:12) and will gradually go down to 8 hours eating window over a period of 8 weeks (16:8). |
| Combination of HICT and IF | Active comparator | Other: Combination of HICT and IFThe group allocated with both exercise and intermittent fasting will be provided with both HICT for three sessions per week and 8 hours' time restricted eating. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Unmarried females
- Diagnosed with PCOS Phenotype A based on Rotterdam Criteria:
- Not engaged in any regular lifestyle intervention for \<3 Months prior to inclusion
Key exclusion criteria (5 listed)
- Use of Estrogen, Progestin or combination.
- Taking medications or supplements for Insulin resistance \< 3 months prior to the inclusion
- Type I or II DM
- Hypo/hyperthyroidism
- BMI ≥27 (Obese according to BMI Asia)
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 |
|---|---|---|
| High Intensity Circuit training (HICT)High Intensity circuit training consisting of circuits of high intensity exercises and progressed up to 8 weeks will be provided. | Other | High Intensity circuit training (HICT) |
| Intermittent Fasting (IF)Time restricted feeding will be used in which the intervention will begin with a 12:12 window leading to a 16:8 IF protocol. | Other | Intermittent fasting (IF) |
| Combination of HICT and IFThe participants will follow both HICT and IF for 8 weeks. | Other | Combination of HICT and IF |
Primary outcome
PCOS Morphology
Time frame: 8th Week
Changes from baseline PCOS morphology on the ultrasound will be done by calculating the number of follicles and measuring follicle size. For this purpose, ultrasound imaging is the best option as it is both harmless and inexpensive. PCOS is considered if on ultrasound imaging there are 12 or more than 12 follicles in the ovary and has size of 2-9 mm or volume of 10 cm 3 .
3 secondary outcomes
Anthropometrics
Time frame: 8th Week
Clinical Hyperandrogenism
Time frame: 8th Week
Body Image concerns
Time frame: 8th Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.
Sarah Ehsan, PP-DPT principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Circuit training (HICT), Intermittent Fasting (IF) and Combination of HICT and IF in people with Polycystic Ovary Syndrome and PCO, run by Riphah International University at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (033324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCOS Morphology (time frame: 8th Week). 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 21 May 2024.