- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07754149
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dr.Rida Zafar, MSWHPT
- Telefonnummer: 03368753273
- E-post: rida.zafar@riphah.edu.pk
Studera Kontakt Backup
- Namn: Dr Summra Andleeb, MS-OMPT
- Telefonnummer: 0345-0617872
- E-post: sammra.andleeb@riphah.edu.pk
Studieorter
-
-
Federal
-
Islamabad, Federal, Pakistan, 051
- Rekrytering
- Kens college model town humak and community model town
-
Kontakt:
- Dr.Rida Zafar
- Telefonnummer: 03368753273
- E-post: rida.zafar@riphah.edu.pk
-
Islamabad, Federal, Pakistan, 051
- Rekrytering
- Kid city high school
-
Kontakt:
- Dr.Rida Zafar
- Telefonnummer: 03368753273
- E-post: rida.zafar@riphah.edu.pk
-
Huvudutredare:
- Amina Rizwan, MSPT(WH)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv komparator: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Premenstrual Symptoms Screening Tool (PSST)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life (QoL)
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Rida Zafar, WHPT, Riphah International University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
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