Autonomic Nervous System Diseases, Menopausal Symptoms, Postmenopausal, Sleep Wake Disorders
Conditions
Keywords
Structured combined exercise, Postmenopausal women, Heart rate variability, Cardiac autonomic function, Menopausal symptoms, Sleep quality, Quality of life
Brief summary
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
BEHAVIORALStructured 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.
Sponsors
Fenerbahce University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to either the exercise intervention group or the control group in a parallel design. The intervention group will receive a structured combined exercise program for 12 weeks, while the control group will continue their usual daily activities.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability | 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
| Measure | Time frame | Description |
|---|---|---|
| Menopause Rating Scale | 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. |
| Sleep Quality | 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. |
| Menopause-Specific Quality of Life | 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. |
| Depressive Symptoms | 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. |
| Hot Flash Frequency and Severity | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBurcu Akkurt, PhD
Outcome results
None listed