Structured Combined Exercise Program in Postmenopausal Women: Effects on Heart Rate Variability and Menopausal Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured Combined Exercise Program.
- Who it may be relevant to
- Registry conditions: Postmenopausal, Menopausal Symptoms, Autonomic Nervous System Diseases, Sleep Wake Disorders. Basic parameters: 45 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of a Structured Combined Exercise Program on Heart Rate Variability and Menopausal Symptoms in Postmenopausal Women: A Randomized Controlled Trial
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Heart Rate Variability [Time frame: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention]
Secondary outcome measures (5)
- Menopause Rating Scale [Time frame: 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]
- Menopause-Specific Quality of Life [Time frame: 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Fenerbahce University — Istanbul
Publications
- Yilmaz Babacan G, Guler Cekic S, Algun ZC, Durmusoglu AF. Effects of exercise training on vasomotor symptoms and quality of life in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2025 Dec 22;25(1):612. doi: 10.1186/s12905-025-04231-y. PMID 41430672
Identifiers
NCT: NCT07615790 · 39.2026fbu