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Structured Combined Exercise Program in Postmenopausal Women: Effects on Heart Rate Variability and Menopausal Symptoms

28. maj 2026 opdateret af: Burcu AKKURT, Fenerbahce University

The Effect of a Structured Combined Exercise Program on Heart Rate Variability and Menopausal Symptoms in Postmenopausal Women: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether a structured combined exercise program can improve heart health, menopausal symptoms, sleep quality, and quality of life in postmenopausal women aged 45 to 65 years.

The main questions it aims to answer are:

Does the exercise program improve heart rate variability, which shows how well the heart is controlled by the nervous system? Does the exercise program lower menopausal symptoms? Does the exercise program improve sleep quality and quality of life?

Researchers will compare women who join the exercise program with women who continue their usual daily activities.

Participants in the exercise group will take part in a supervised exercise program for 12 weeks. They will exercise 2 days each week. Each session will last 45 minutes and will include warm-up, balance, strengthening, coordination, flexibility, and cool-down exercises.

Participants in the control group will continue their usual daily activities during the study.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Menopause is associated with hormonal changes that may negatively affect cardiovascular, neurological, and psychological health. Reduced estrogen levels during the postmenopausal period have been linked to autonomic nervous system dysfunction, increased cardiovascular risk, vasomotor symptoms, sleep disturbances, anxiety, depressive symptoms, and reduced quality of life. Heart rate variability (HRV) is a non-invasive marker of cardiac autonomic nervous system function and reflects the balance between sympathetic and parasympathetic activity. Lower HRV values have been associated with stress, poor sleep quality, and psychological symptoms in postmenopausal women.

Exercise is considered one of the most effective non-pharmacological interventions for improving menopausal symptoms and cardiovascular health. Previous studies suggest that regular exercise may improve autonomic nervous system regulation and HRV. However, evidence regarding the effects of structured combined exercise programs on HRV and menopausal symptoms in postmenopausal women remains limited and inconsistent. In addition, few randomized controlled studies have examined the relationship between changes in autonomic nervous system function and menopausal symptoms.

This randomized controlled trial aims to investigate the effects of a structured combined exercise program on cardiac autonomic nervous system function assessed by HRV in postmenopausal women. Secondary aims are to evaluate the effects of the exercise program on menopausal symptoms, sleep quality, and quality of life, and to examine the relationship between changes in HRV and symptom-related outcomes.

The intervention will consist of a 12-week supervised structured combined exercise program performed twice weekly. Each session will include warm-up, balance, strengthening, coordination, flexibility, and cool-down exercises. Exercises will be progressively adjusted according to participants' functional capacity and performed under physiotherapist supervision.

Statistical analyses will be conducted using IBM SPSS Statistics version 25.0. Data distribution will be assessed using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Appropriate parametric and non-parametric statistical tests will be used for within-group and between-group comparisons. Statistical significance will be accepted at p < 0.05.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Women in the postmenopausal period
  • Aged between 45 and 65 years
  • Able to communicate and cooperate with the researchers
  • Not participating in another structured exercise program
  • Willing to participate voluntarily in the study

Exclusion Criteria:

  • Presence of severe cardiovascular, neurological, orthopedic, or psychiatric disease
  • Hormone replacement therapy use during the study period
  • Cognitive impairment affecting participation
  • Uncontrolled hypertension or other unstable medical conditions
  • Regular participation in structured exercise training within the last 6 months
  • Smoking or alcohol use that may affect heart rate variability measurements

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise Group
Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision.
Adfærdsmæssigt: Structured Combined Exercise Program
The intervention consists of a supervised 12-week structured combined exercise program performed twice weekly. Each 45-minute session includes warm-up, balance, strengthening, coordination, flexibility, and cool-down exercises.
Ingen indgriben: Control Group
Participants in the control group will continue their usual daily activities and will not receive any structured exercise intervention during the study period. At the end of the study, participants in the control group will be informed about the exercise program, and volunteers will be offered the opportunity to participate in the program in accordance with ethical considerations.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart Rate Variability
Tidsramme: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Cardiac autonomic nervous system function will be assessed using heart rate variability parameters including standard deviation of normal-to-normal intervals (SDNN), root mean square of successive differences (RMSSD), low-frequency power (LF), high-frequency power (HF), and low-frequency/high-frequency ratio (LF/HF ratio).
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Menopause Rating Scale
Tidsramme: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Menopausal symptoms will be assessed using the Menopause Rating Scale (MRS), an 11-item questionnaire evaluating somatic, psychological, and urogenital symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms). Total scores range from 0 to 44, with higher scores indicating more severe menopausal symptoms.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Sleep Quality
Tidsramme: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-reported questionnaire with scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Menopause-Specific Quality of Life
Tidsramme: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Menopause-specific quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL). The questionnaire assesses vasomotor, psychosocial, physical, and sexual domains. Item and domain scores range from 1 to 8, with higher scores indicating poorer menopause-specific quality of life.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Depressive Symptoms
Tidsramme: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Depressive symptoms will be assessed using the Geriatric Depression Scale-Short Form (GDS-SF), a 15-item questionnaire with scores ranging from 0 to 15. Higher scores indicate more severe depressive symptoms.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Hot Flash Frequency and Severity
Tidsramme: Daily throughout the 12-week intervention period and daily during the 8-week post-intervention follow-up period
Frequency and severity of hot flashes and night sweats will be recorded using a daily symptom diary.
Daily throughout the 12-week intervention period and daily during the 8-week post-intervention follow-up period

Samarbejdspartnere og efterforskere

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Sponsor

Fenerbahce University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. april 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 39.2026fbu

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