FemalesNCT05460741
Integrated Exercise Approach Strength Postural Stability Menstrual Cycle Biomarkers Eumenorrheic Females
A study testing integrated exercise approach and educational program in people with Females and Menstrual Discomfort, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will determine the effects of integrated exercise approach on strength, postural stability and biomarkers (estrogen, progesterone and testosterone) of menstrual cycle in eumenorrheic females and translation of Unified Balance Scale will be done. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Females, Menstrual Discomfort
- What is being tested?
- integrated exercise approach and educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between the ages of 18 to 40 years.
- Females having BMI between 18.5 to 24.9 (normal)
- Females being able to maintain sitting balance independently without using upper limbs or having score of 25 on trunk control test.
Who cannot join
- Females having oral contraceptives.
- Females who are pregnant.
- Females who have any menstruation issues like endometriosis, ovarian cysts etc
- Females who have c section 6 months ago.
- Females who are lactating.
- Females having other co morbidities like cardiac event, seizures, any injury that will affect the study.
- Females having history of fall 6 months ago.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Integrated Exercise Approach on Strength, Postural Stability and Biomarkers of Menstrual Cycle in Eumenorrheic Females
The study will determine the effects of integrated exercise approach on strength, postural stability and biomarkers (estrogen, progesterone and testosterone) of menstrual cycle in eumenorrheic females and translation of Unified Balance Scale will be done.
Read the detailed description
In 2021, a study was conducted in which evaluation of the effects of phases of menstrual cycles on the performance of athletes was done. It was concluded that the performance of athletes is effected along with phases of MC with strength and aerobic performance being effected during late luteal phase and anerobic performance was reduced during late follicular phase.
In 2021, another study was conducted. The bidirectional interactions between the menstrual cycle, exercise training and macronutrient intake in women was studied. It was concluded in their study that exercise interventions have an effect on the hormonal level and in turn their physical activity but it varies so much from one women to other that no generalization may be made and need to be investigated more.
In 2020, a systematic review related to effects of menstrual cycle phase on exercise performance in eumenorrhic women was done. It was concluded that exercise performance may get reduced in the early follicular phase so the practitioners working with sportswomen must consider the phases of their menstrual cycle and look for the potential times when their performances may be enhanced that is in all phases except follicular phase to get the optimum results during their games.
In 2020, the study related to the effects of sex steroids on joint position sense during different phases of menstrual cycle was done. It was concluded in this study that in early follicular phase as the levels of sex steroid hormone specifically oestrogen is low, it leads to decrease joint position sense as compared to luteal and ovulatory phases where there is less error in joint position sense. These findings are more pronounced in the hip joint due to greater motor neuron activity of these muscles.
In 2019, study was conducted in which it was documented that when exercise is performed it has certain physiological effects and the phases of menstrual cycle plays an important role in modulating these physiological responses during recovery phase. He postulated that a more robust recovery CK and IL-6 response occur in the MF of the menstrual late cycle when female sex hormones are reduced.
In 2018, the combined effects of strength and endurance training on the biomarkers and physical activity of healthy women were studied. It was hypothesized by this study that even with limited exposure to strengthening and endurance programs the females can get benefit as compared to the sedentary women. Their health biomarkers also showed positive effects.
In 2017, evaluation of muscle strength variations and also the rate of fatigue during various phases of the menstrual cycle in young adults was done. It was hypothesized that cyclical variation in endogenous reproductive hormones increases the muscle strength in follicular phase of the menstrual cycle. Thus provide support for the influence of these hormones in regulation of these parameters in the premenopausal age group.
In 2017, study was conducted to see the effects of menstrual cycle phases on the performance of athletes specifically soccer players. The result of this study was in support of reduction in maximal endurance performance during the mid luteal phase of the menstrual cycle confirming the fact that the phases of menstrual cycle do have effect on the endurance of the athletes so the trainer should consider these fact while training of the female athletes.
In 2015, a systematic review was done to include 40 studies in which different exercises were done including strength exercises, endurance exercises and free style exercises and their effects were then seen on sex hormones. It was concluded by this study that physical activity which ever type it may be induces a decrease in circulating sex hormones and this induces the beneficial effects on women. It also helps in weight loss and overall physical well being.
So it is evident that some work has been done on documenting the effects of exercise on estrogen, progesterone level but little is known about the effects of exercise on testosterone levels. The regulation of both of them is necessary to maintain the effective force production of muscles, joint laxity and balance control. Moreover, there is no single generalized approach which focuses on strength, postural stability and postulated to effects hormones.
- Conditions
- Females, Menstrual Discomfort
- Being tested
- integrated exercise approach, educational program
- Keywords
- exercise performance, menstrual cycle, sex steroid hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated exercise approachOther
Also called educational program
Integrated exercise plan will be given for 16 weeks with frequency of 3 times per week, with duration of session to be 50 minutes being 30 minutes of exercise in total and 10 minutes of rest and 10 min of warm up and cool down exercises.
educational programOther
educational program related to menstrual cycle will be given to females.
| Study group | Role | What they receive |
|---|---|---|
| integrated exercise approach | Experimental | an integrated exercise will be used which is the exercise plan that will be formulated using strengthening and endurance exercises. Receives: Other: integrated exercise approach |
| eumenhorreic females | Experimental | strength, postural stability and biomarkers of menstrual cycle in eumenhorreic females. Receives: Other: educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
ELISA
progesterone, testosterone and estrogen of the females with no menstrual cycle dysfunction will be documented at baseline and then the exercise plan along with menstrual cycle education will be given to one group and just educational program will be given to other. the biomarkers will then be assesd after 2 months and at the end of study i.e, after 4 months.The unit of measurement of progesterone is ng/ml. progesterone is less than 1.5ng/ml in follicular phase, greater than 3ng/ml in ovulatory phase and 2 to 25ng/ml in luteal phase, testosterone is measured in nmol/L, being 0.32nmol/L in follicular phase and 0.35nmol/L in ovulatory and luteal phase. estrogen measured in pg/ml, being less than 50pg/ml in follicular phase, 400 pg/ml in ovulatory phase and upto 200pg/ml in luteal phase.this test has 68% sensitivity and 98% specificity
Measured: 4 months
Secondary outcomes (2)
hand held dynamometer
grip strength of females will be taken at baseline and then after 2 months and 4 months to see the effect of intervention on it. It ranges from 21.5 kg to 35.3kg which varies from dominant to non dominant hand and varies with age too. it has high reliability from 0.85 to 0.99
Measured: 4 months
pressure biofeedback unit
it will be used to measure the strength of lower limb at baseline, after 2months and 4 months. For quadriceps it ranges from 16 to 20 kg and 18 to 20 kg in hamstrings. This test has a reliability of 0.86
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Mar 2022
- Primary completion25 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FemalesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- there will be 2 groups. one will be given the education related to menstrual cycle and other will be given intervention along with education. then the outcomes will be assessed at multiple times of study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460741
- Sponsor's protocol ID
- REC/Lhr/22/1101
- Status last verified
- Apr 2024
- First submitted
- 31 May 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rocha-Rodrigues S, Sousa M, Lourenco Reis P, Leao C, Cardoso-Marinho B, Massada M, Afonso J. Bidirectional Interactions between the Menstrual Cycle, Exercise Training, and Macronutrient Intake in Women: A Review. Nutrients. 2021 Jan 29;13(2):438. doi: 10.3390/nu13020438.
PubMed 33572821Kitajima Y, Ono Y. Estrogens maintain skeletal muscle and satellite cell functions. J Endocrinol. 2016 Jun;229(3):267-75. doi: 10.1530/JOE-15-0476. Epub 2016 Apr 5.
PubMed 27048232Le J, Thomas N, Gurvich C. Cognition, The Menstrual Cycle, and Premenstrual Disorders: A Review. Brain Sci. 2020 Mar 27;10(4):198. doi: 10.3390/brainsci10040198.
PubMed 32230889Smith MJ, Adams LF, Schmidt PJ, Rubinow DR, Wassermann EM. Effects of ovarian hormones on human cortical excitability. Ann Neurol. 2002 May;51(5):599-603. doi: 10.1002/ana.10180.
PubMed 12112106Shahid W, Noor R. Effects of integrated exercise approach on total testosterone levels in eumenorrheic women: a randomized controlled trial. Sci Rep. 2025 May 5;15(1):15692. doi: 10.1038/s41598-025-00599-x.
PubMed 40325081Shahid W, Noor R. Impact of BRACTS exercises on muscular strength in eumenorrheic women. Sci Rep. 2025 Feb 5;15(1):4430. doi: 10.1038/s41598-025-87352-6.
PubMed 39910068
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrated Exercise Approach on Strength, Postural Stability and Biomarkers of Menstrual Cycle in Eumenorrheic Females
- ClinicalTrials.gov ID
- NCT05460741
- Acronym / sponsor ID
- REC/Lhr/22/1101
- Conditions
- Females, Menstrual Discomfort
- Keywords
- exercise performance, menstrual cycle, sex steroid hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 15 Jul 2022 (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 study will determine the effects of integrated exercise approach on strength, postural stability and biomarkers (estrogen, progesterone and testosterone) of menstrual cycle in eumenorrheic females and translation of Unified Balance Scale will be done.
Detailed description
In 2021, a study was conducted in which evaluation of the effects of phases of menstrual cycles on the performance of athletes was done. It was concluded that the performance of athletes is effected along with phases of MC with strength and aerobic performance being effected during late luteal phase and anerobic performance was reduced during late follicular phase.
In 2021, another study was conducted. The bidirectional interactions between the menstrual cycle, exercise training and macronutrient intake in women was studied. It was concluded in their study that exercise interventions have an effect on the hormonal level and in turn their physical activity but it varies so much from one women to other that no generalization may be made and need to be investigated more.
In 2020, a systematic review related to effects of menstrual cycle phase on exercise performance in eumenorrhic women was done. It was concluded that exercise performance may get reduced in the early follicular phase so the practitioners working with sportswomen must consider the phases of their menstrual cycle and look for the potential times when their performances may be enhanced that is in all phases except follicular phase to get the optimum results during their games.
In 2020, the study related to the effects of sex steroids on joint position sense during different phases of menstrual cycle was done. It was concluded in this study that in early follicular phase as the levels of sex steroid hormone specifically oestrogen is low, it leads to decrease joint position sense as compared to luteal and ovulatory phases where there is less error in joint position sense. These findings are more pronounced in the hip joint due to greater motor neuron activity of these muscles.
In 2019, study was conducted in which it was documented that when exercise is performed it has certain physiological effects and the phases of menstrual cycle plays an important role in modulating these physiological responses during recovery phase. He postulated that a more robust recovery CK and IL-6 response occur in the MF of the menstrual late cycle when female sex hormones are reduced.
In 2018, the combined effects of strength and endurance training on the biomarkers and physical activity of healthy women were studied. It was hypothesized by this study that even with limited exposure to strengthening and endurance programs the females can get benefit as compared to the sedentary women. Their health biomarkers also showed positive effects.
In 2017, evaluation of muscle strength variations and also the rate of fatigue during various phases of the menstrual cycle in young adults was done. It was hypothesized that cyclical variation in endogenous reproductive hormones increases the muscle strength in follicular phase of the menstrual cycle. Thus provide support for the influence of these hormones in regulation of these parameters in the premenopausal age group.
In 2017, study was conducted to see the effects of menstrual cycle phases on the performance of athletes specifically soccer players. The result of this study was in support of reduction in maximal endurance performance during the mid luteal phase of the menstrual cycle confirming the fact that the phases of menstrual cycle do have effect on the endurance of the athletes so the trainer should consider these fact while training of the female athletes.
In 2015, a systematic review was done to include 40 studies in which different exercises were done including strength exercises, endurance exercises and free style exercises and their effects were then seen on sex hormones. It was concluded by this study that physical activity which ever type it may be induces a decrease in circulating sex hormones and this induces the beneficial effects on women. It also helps in weight loss and overall physical well being.
So it is evident that some work has been done on documenting the effects of exercise on estrogen, progesterone level but little is known about the effects of exercise on testosterone levels. The regulation of both of them is necessary to maintain the effective force production of muscles, joint laxity and balance control. Moreover, there is no single generalized approach which focuses on strength, postural stability and postulated to effects hormones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- there will be 2 groups. one will be given the education related to menstrual cycle and other will be given intervention along with education. then the outcomes will be assessed at multiple times of study.
| Arm | Type | Receives |
|---|---|---|
| integrated exercise approach | Experimental | Other: integrated exercise approachan integrated exercise will be used which is the exercise plan that will be formulated using strengthening and endurance exercises. |
| eumenhorreic females | Experimental | Other: educational programstrength, postural stability and biomarkers of menstrual cycle in eumenhorreic females. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females between the ages of 18 to 40 years.
- Females having BMI between 18.5 to 24.9 (normal)
- Females being able to maintain sitting balance independently without using upper limbs or having score of 25 on trunk control test.
Key exclusion criteria (7 listed)
- Females having oral contraceptives.
- Females who are pregnant.
- Females who have any menstruation issues like endometriosis, ovarian cysts etc
- Females who have c section 6 months ago.
- Females who are lactating.
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 |
|---|---|---|
| integrated exercise approachAlso: educational programIntegrated exercise plan will be given for 16 weeks with frequency of 3 times per week, with duration of session to be 50 minutes being 30 minutes of exercise in total and 10 minutes of rest and 10 min of warm up and cool down exercises. | Other | integrated exercise approach |
| educational programeducational program related to menstrual cycle will be given to females. | Other | eumenhorreic females |
Primary outcome
ELISA
Time frame: 4 months
progesterone, testosterone and estrogen of the females with no menstrual cycle dysfunction will be documented at baseline and then the exercise plan along with menstrual cycle education will be given to one group and just educational program will be given to other. the biomarkers will then be assesd after 2 months and at the end of study i.e, after 4 months.The unit of measurement of progesterone is ng/ml. progesterone is less than 1.5ng/ml in follicular phase, greater than 3ng/ml in ovulatory phase and 2 to 25ng/ml in luteal phase, testosterone is measured in nmol/L, being 0.32nmol/L in follicular phase and 0.35nmol/L in ovulatory and luteal phase. estrogen measured in pg/ml, being less than 50pg/ml in follicular phase, 400 pg/ml in ovulatory phase and upto 200pg/ml in luteal phase.this test has 68% sensitivity and 98% specificity
2 secondary outcomes
hand held dynamometer
Time frame: 4 months
pressure biofeedback unit
Time frame: 4 months
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 30 Apr 2024.
- Background: PubMed 33572821Rocha-Rodrigues S, Sousa M, Lourenco Reis P, Leao C, Cardoso-Marinho B, Massada M, Afonso J. Bidirectional Interactions between the Menstrual Cycle, Exercise Training, and Macronutrient Intake in Women: A Review. Nutrients. 2021 Jan 29;13(2):438. doi: 10.3390/nu13020438.
- Background: PubMed 27048232Kitajima Y, Ono Y. Estrogens maintain skeletal muscle and satellite cell functions. J Endocrinol. 2016 Jun;229(3):267-75. doi: 10.1530/JOE-15-0476. Epub 2016 Apr 5.
- Background: PubMed 32230889Le J, Thomas N, Gurvich C. Cognition, The Menstrual Cycle, and Premenstrual Disorders: A Review. Brain Sci. 2020 Mar 27;10(4):198. doi: 10.3390/brainsci10040198.
- Background: PubMed 12112106Smith MJ, Adams LF, Schmidt PJ, Rubinow DR, Wassermann EM. Effects of ovarian hormones on human cortical excitability. Ann Neurol. 2002 May;51(5):599-603. doi: 10.1002/ana.10180.
- Derived from this study: PubMed 40325081Shahid W, Noor R. Effects of integrated exercise approach on total testosterone levels in eumenorrheic women: a randomized controlled trial. Sci Rep. 2025 May 5;15(1):15692. doi: 10.1038/s41598-025-00599-x.
- Derived from this study: PubMed 39910068Shahid W, Noor R. Impact of BRACTS exercises on muscular strength in eumenorrheic women. Sci Rep. 2025 Feb 5;15(1):4430. doi: 10.1038/s41598-025-87352-6.
- 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.
Rabiya Noor, phd* 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 integrated exercise approach and educational program in people with Females and Menstrual Discomfort, 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 3 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: finished, as of the sponsor's last update on 30 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?
ELISA (time frame: 4 months). 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 NCT05460741, which also lists 6 linked publications.
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 30 Apr 2024.