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NCT Number: NCT07615790

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Combined Exercise Program

Behavioral

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.

Primary outcomes

  1. Heart Rate Variability

    Time frame: 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).

Secondary outcomes

  1. Menopause Rating Scale

    Time frame: 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.

  2. Sleep Quality

    Time frame: 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.

  3. Menopause-Specific Quality of Life

    Time frame: 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.

  4. Depressive Symptoms

    Time frame: 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.

  5. Hot Flash Frequency and Severity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu Akkurt, PhD

CONTACT

[email protected]

+90 553 604 6713

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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