NCT07754149

Brief Summary

This study examines the dose-response effects of a 6-week progressive resistance training program on premenstrual syndrome (PMS) in adolescent girls. PMS is a common condition that affects physical, psychological, and social well-being. While exercise is known to reduce symptoms, the optimal intensity of resistance training remains unclear. Using a randomized controlled trial design, participants are assigned to progressive or low-intensity training groups. PMS symptoms and quality of life are assessed over time. The study aims to determine whether higher exercise intensity leads to greater symptom reduction and improved overall well-being.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Aug 2026Jan 2027

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Premenstrual Syndrome, Resistance Training, Dose-Response, Adolescent Girls, Exercise Therapy, Quality of Life, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Symptoms Screening Tool (PSST)

    The primary outcome of this study is the severity of premenstrual syndrome symptoms, measured using the Premenstrual Symptoms Screening Tool (PSST). The PSST is a self-reported questionnaire used to assess physical, psychological, and behavioral symptoms related to PMS, including mood swings, irritability, anxiety, fatigue, bloating, breast tenderness, and difficulty concentrating. It also evaluates how these symptoms affect daily activities, school performance, and social relationships. Each item is scored on a 4-point Likert scale ranging from "none" to "severe." Higher scores indicate greater PMS severity..

    Assessments will be conducted at baseline, week 2, week 4, week 6, and at 3-month follow-up

Secondary Outcomes (1)

  • Quality of Life (QoL)

    Quality of life will be assessed at baseline, immediately after the 6-week intervention, and at 3-month follow-up using the WHOQOL-BREF questionnaire.

Study Arms (2)

Progressive Resistance Training Group

EXPERIMENTAL

Participants allocated to this arm will receive a supervised 6-week progressive resistance training program performed three times per week on non-consecutive days. Each session will last 45-60 minutes.

Other: Progressive Resistance Training

Low-Intensity Resistance Training Group

ACTIVE COMPARATOR

Participants allocated to this arm will receive a supervised low-intensity resistance training program for six weeks. Sessions will be conducted three times per week, lasting 45-60 minutes each. Participants will perform the same standardized resistance exercises as the experimental group; however, exercise intensity will remain low throughout the intervention without progressive overload.

Other: Low-Intensity Resistance Training

Interventions

A supervised progressive resistance training program delivered three sessions per week for six weeks. Exercise intensity is gradually increased using the Borg Rating of Perceived Exertion (RPE) scale. A warm up session will be done before resistance training exercise and Cool down for 5-10 minutes will be done exercise. Participants will follow the FITT prescription for their resistance exercises. Week 1-2 (DOSE 1) Intensity: Low. Bodyweight or dumbbells (RPE 7-11/20). Sets \& Reps: 2 sets of 25-30 reps. Volume: High. Focus on mastering technique. Week 3-4 (DOSE 2) Intensity: moderate. Bodyweight or dumbbells (RPE 12-14/20). Sets \& Reps: 2 sets of 20-25 repetitions. Volume: Moderate. Focus on mastering technique. Week 5-6(DOSE 3) Intensity: high. Dumbbells (RPE 15-16/20). Sets \& Reps: 2 sets of 15-20 repetitions. Volume: Low.

Progressive Resistance Training Group

Participants of this group will receive the same standardized exercises as the experimental group. Exercise intensity remains constant at low intensity throughout the intervention period without progressive increase. Before exercise the participants will perform warm up and after exercise they will perform cool down, same as the experimental group. The FITT protocol for this group is as following: Week 1-2 (DOSE1) Intensity: low Body weight. or Dumbbells (RPE 7-11/20). Sets \& Reps: 2 sets of 15repetitions. Volume: Low. Focus on mastering technique. Week 3-4 (DOSE 2) Intensity: low. Bodyweight or dumbbells (RPE 7-11/20). Sets \& Reps: 2 sets of 20 repetitions. Volume: Moderate. Focus on mastering technique Week 5-6(DOSE 3) Intensity: Low. Bodyweight or dumbbells (RPE 7-11/20). Sets \& Reps: 2 sets of 25 reps. Volume: High. Focus on mastering technique.

Low-Intensity Resistance Training Group

Eligibility Criteria

Age11 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study will include only adolescent participants who self-identify as female. This is because the target population consists of adolescent girls experiencing premenstrual syndrome (PMS), and the intervention is specifically designed for this group."
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed with Premenstrual Syndrome (PMS) based on PSST screening tool.
  • Not currently engaged in any structured resistance or exercise training program.
  • Medically cleared to participate in moderate-intensity resistance training.
  • Provided written informed consent for participation.

You may not qualify if:

  • Current use of hormonal therapy or oral contraceptives.
  • History of endocrine disorders (e.g., PCOS, thyroid dysfunction).
  • Any musculoskeletal or cardiovascular condition limiting exercise participation.
  • Ongoing psychiatric medication or diagnosed depression/anxiety disorder.
  • Participation in a structured exercise or resistance training program within the last 3 months.
  • Use of analgesics, anti-inflammatory, or hormonal medications during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kid city high school , Kens college model town humak and community model town.

Islamabad, Federal, 051, Pakistan

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rida Zafar, WHPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Rida Zafar, MSWHPT

CONTACT

Dr Summra Andleeb, MS-OMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to ensure participant confidentiality and data protection, particularly because the study involves adolescent girls, and data was collected for specific research purposes only."

Locations