Integrated Exercise Approach Strength Postural Stability Menstrual Cycle Biomarkers Eumenorrheic Females

NCT05460741 | Completed

• 1 other identifier: REC/Lhr/22/1101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Females; Menstrual Discomfort

Keywords

exercise performance; menstrual cycle; sex steroid hormones

Outcome Measures

Primary Outcomes (1)

• 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

  4 months

Secondary Outcomes (2)

• hand held dynamometer

  4 months

• pressure biofeedback unit

  4 months

Other Outcomes (1)

• global postural system

  4 months

Study Arms (2)

integrated exercise approach

EXPERIMENTAL

an integrated exercise will be used which is the exercise plan that will be formulated using strengthening and endurance exercises.

Other: integrated exercise approach

eumenhorreic females

EXPERIMENTAL

strength, postural stability and biomarkers of menstrual cycle in eumenhorreic females.

Other: educational program

Interventions

integrated exercise approach OTHER

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.

Also known as: educational program

integrated exercise approach

educational program OTHER

educational program related to menstrual cycle will be given to females.

eumenhorreic females

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: females having no problem in menstrual cycle
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead
• University of Lahore: collaborator

Study Sites (1)

Society

Lahore, Punjab Province, 40050, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 33572821 BACKGROUND

• 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.

  PMID: 27048232 BACKGROUND

• 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.

  PMID: 32230889 BACKGROUND

• 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.

  PMID: 12112106 BACKGROUND

• Shahid 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.

  PMID: 40325081 DERIVED

• Shahid 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.

  PMID: 39910068 DERIVED

Study Officials

• Rabiya Noor, phd*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: July 15, 2022
• Study Start: March 15, 2022
• Primary Completion: February 25, 2024
• Study Completion: March 15, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)