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

28 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Exercise Group
Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision.
Comportemental: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Heart Rate Variability
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Menopause Rating Scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fenerbahce University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 avril 2026

Achèvement primaire (Estimé)

1 juillet 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 39.2026fbu

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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