- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06868134
Efficacy of Exercise Methods in Postmenopausal Women: A Clinical Trial
Effektiviteten av forskjellige treningsapplikasjonsmetoder hos postmenopausale kvinner
This study aims to evaluate the effectiveness of different exercise methods in improving health outcomes for postmenopausal women. As women go through menopause, they may experience changes such as decreased bone density, muscle weakness, and an increased risk of chronic diseases. Exercise is known to be beneficial in reducing these risks, but the best approach remains unclear.
In this clinical trial, participants will engage in structured exercise programs designed to improve bone health, strength, and overall well-being. The study will compare different types of exercises to determine which method provides the most benefits. By participating in this research, postmenopausal women can contribute to a better understanding of how exercise can enhance health during this stage of life.
This study is safe, and all exercises are guided by professionals. The results will help healthcare providers recommend the most effective exercise strategies for postmenopausal women.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Beykoz
-
Istanbul, Beykoz, Tyrkia (Türkiye), 34000
- Istanbul Medipol University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Being between 40-65 years of age Having a Body Mass Index (BMI) below 40 Scoring 68 or above on the System Usability Scale Having no orthopedic problems Completing the informed consent form Being within 5 years after a 12-month amenorrhea history
Exclusion Criteria:
- Presence of visual impairments Presence of musculoskeletal system disorders Presence of cognitive impairments Presence of joint range of motion limitations Presence of severe cardiac problems Participation in another program
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Group
Participants in this group will not receive any intervention |
|
|
Eksperimentell: Supervised Exercise Group
Participants in this group will receive a supervised progressive exercise program including stretching, strengthening, and aerobic exercises. The intervention will be performed 3 times per week with at least one rest day between sessions. |
Participants in this group will receive a supervised progressive exercise program consisting of stretching, strengthening, and aerobic exercises. The intervention will be conducted three times per week with at least one rest day between sessions. |
|
Eksperimentell: Web-Based Exercise Group
Participants in this group will follow a progressive exercise program through the Physitrack web platform. At the beginning and at the end of the 8th week, participants will be assessed. A profile will be created for each participant by the researcher, and the individualized progressive exercise program will be assigned to their profiles. The intervention will be performed 3 times per week with at least one rest day between sessions. |
Participants will follow a structured progressive exercise program through the Physitrack web platform, including stretching, strengthening, and aerobic exercises. The program will be assigned to each participant's profile, and they will complete the exercises three times per week with at least one rest day between sessions. Assessments will be conducted at the beginning and at the end of the 8th week. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Composition (Fat Mass, Lean Mass, and BMI) Assessed by Bioelectrical Impedance Analysis (BIA)
Tidsramme: Baseline and Week 8
|
Body composition (fat mass, lean mass, and BMI) measured using bioelectrical impedance analysis (BIA). Higher fat mass may be associated with lower exercise capacity. |
Baseline and Week 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Menopause Symptom Assessment Scale Score
Tidsramme: Baseline and Week 8
|
Change in menopause symptoms assessed by the Menopause Symptom Assessment Scale. The scale consists of 11 items rated from 0 to 4, with a maximum score of 44. Higher scores indicate worse quality of life. |
Baseline and Week 8
|
|
Fatigue Severity Scale Score
Tidsramme: Baseline and Week 8
|
Fatigue levels measured using the Fatigue Severity Scale (FSS), which consists of 9 questions scored between 0 and 7. A total score of 28 or above indicates severe fatigue. |
Baseline and Week 8
|
|
Beck Depression Inventory (BDI) Score
Tidsramme: Baseline and Week 8
|
Depression levels assessed using the Beck Depression Inventory (BDI), with scores categorized into minimal, mild, moderate, and severe depression. A score above 30 indicates severe depression. |
Baseline and Week 8
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
Tidsramme: Baseline and Week 8
|
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI), with a total score range of 0-21. A total score greater than 5 indicates poor sleep quality. |
Baseline and Week 8
|
|
Short Form-36 (SF-36) Quality of Life Scale Score
Tidsramme: Baseline and Week 8
|
Quality of life will be measured using the Short Form-36 (SF-36) questionnaire, which evaluates physical and emotional well-being across 8 domains. |
Baseline and Week 8
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- E-10840098-772.02-4975
Plan for individuelle deltakerdata (IPD)
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