- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07754149
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr.Rida Zafar, MSWHPT
- Phone Number: 03368753273
- Email: rida.zafar@riphah.edu.pk
Study Contact Backup
- Name: Dr Summra Andleeb, MS-OMPT
- Phone Number: 0345-0617872
- Email: sammra.andleeb@riphah.edu.pk
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 051
- Recruiting
- Kens college model town humak and community model town
-
Contact:
- Dr.Rida Zafar
- Phone Number: 03368753273
- Email: rida.zafar@riphah.edu.pk
-
Islamabad, Federal, Pakistan, 051
- Recruiting
- Kid city high school
-
Contact:
- Dr.Rida Zafar
- Phone Number: 03368753273
- Email: rida.zafar@riphah.edu.pk
-
Principal Investigator:
- Amina Rizwan, MSPT(WH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Progressive Resistance Training Group
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.
|
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. |
|
Active Comparator: Low-Intensity Resistance Training Group
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Premenstrual Symptoms Screening Tool (PSST)
Time Frame: Assessments will be conducted at baseline, week 2, week 4, week 6, and at 3-month follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (QoL)
Time Frame: 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.
|
Quality of life will be assessed using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF).
This questionnaire contains 26 items and evaluates four domains: physical health, psychological health, social relationships, and environmental well-being.
Each item is rated on a 5-point Likert scale, with higher scores representing better quality of life.
The WHOQOL-BREF is a reliable and valid tool commonly used in clinical and research settings to assess overall well-being.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rida Zafar, WHPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Amina Rizwan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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