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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorFenerbahce University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Exercise GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Heart Rate Variability

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).

Time frame
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention

Secondary outcomes

1

Menopause Rating Scale

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.

Time frame
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
2

Sleep Quality

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.

Time frame
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
3

Menopause-Specific Quality of Life

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.

Time frame
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
4

Depressive Symptoms

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.

Time frame
Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention

Other outcomes

Sponsors and contacts

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