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- Klinische proef NCT07754149
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Dr.Rida Zafar, MSWHPT
- Telefoonnummer: 03368753273
- E-mail: rida.zafar@riphah.edu.pk
Studie Contact Back-up
- Naam: Dr Summra Andleeb, MS-OMPT
- Telefoonnummer: 0345-0617872
- E-mail: sammra.andleeb@riphah.edu.pk
Studie Locaties
-
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Federal
-
Islamabad, Federal, Pakistan, 051
- Werving
- Kens college model town humak and community model town
-
Contact:
- Dr.Rida Zafar
- Telefoonnummer: 03368753273
- E-mail: rida.zafar@riphah.edu.pk
-
Islamabad, Federal, Pakistan, 051
- Werving
- Kid city high school
-
Contact:
- Dr.Rida Zafar
- Telefoonnummer: 03368753273
- E-mail: rida.zafar@riphah.edu.pk
-
Hoofdonderzoeker:
- Amina Rizwan, MSPT(WH)
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Premenstrual Symptoms Screening Tool (PSST)
Tijdsspanne: 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..
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Assessments will be conducted at baseline, week 2, week 4, week 6, and at 3-month follow-up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of Life (QoL)
Tijdsspanne: 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.
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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.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rida Zafar, WHPT, Riphah International University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Amina Rizwan
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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