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

May 28, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Group
Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision.
Behavioral: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Daily throughout the 12-week intervention period and daily during the 8-week post-intervention follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenerbahce University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39.2026fbu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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