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

28 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Exercise Group
Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart Rate Variability
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Menopause Rating Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fenerbahce University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 april 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 september 2026

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 39.2026fbu

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