Clinical trial NCT05460741: Integrated Exercise Approach Strength Postural Stability Menstrual Cycle Biomarkers Eumenorrheic Females
Official title: Effects of Integrated Exercise Approach on Strength, Postural Stability and Biomarkers of Menstrual Cycle in Eumenorrheic Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Females
Menstrual Discomfort
Keywords: exercise performance
menstrual cycle
sex steroid hormones
Lead sponsor: Riphah International University
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2022-07-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ELISA
timeFrame: 4 months
Secondary outcomes:
measure: hand held dynamometer
timeFrame: 4 months
measure: pressure biofeedback unit
timeFrame: 4 months
Other outcomes:
measure: global postural system
timeFrame: 4 months
Locations:
city: Lahore
country: Pakistan
facility: Society
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, phd*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kitajima 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.
citation: Le 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.
citation: Smith 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.