PostmenopausalNCT07615790
Structured Combined Exercise Program in Postmenopausal Women: Effects on Heart Rate Variability and Menopausal Symptoms
A study testing Structured Combined Exercise Program in people with Postmenopausal and Menopausal Symptoms, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopausal, Menopausal Symptoms, Autonomic Nervous System Diseases
- What is being tested?
- Structured Combined Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fenerbahce University
Istanbul, Atasehir
Burcu Akkurt, PhD, +90 553 604 6713, burcu.akkurt@fbu.edu.tr
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Postmenopausal, Menopausal Symptoms, Autonomic Nervous System Diseases, Sleep Wake Disorders
- Being tested
- Structured Combined Exercise Program
- Keywords
- Structured combined exercise, Postmenopausal women, Heart rate variability, Cardiac autonomic function, Menopausal symptoms, Sleep quality, Quality of life
- Medical subject headings
- Autonomic Nervous System Diseases, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Combined Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision. Receives: Behavioral: Structured Combined Exercise Program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Secondary outcomes (5)
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.
Measured: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Measured: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Measured: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
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.
Measured: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention
Hot Flash Frequency and Severity
Frequency and severity of hot flashes and night sweats will be recorded using a daily symptom diary.
Measured: Daily throughout the 12-week intervention period and daily during the 8-week post-intervention follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start27 Apr 2026
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu AKKURT, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615790
- Sponsor's protocol ID
- 39.2026fbu
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41430672
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Structured Combined Exercise Program on Heart Rate Variability and Menopausal Symptoms in Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07615790
- Acronym / sponsor ID
- 39.2026fbu
- Conditions
- Postmenopausal, Menopausal Symptoms, Autonomic Nervous System Diseases, Sleep Wake Disorders
- Keywords
- Structured combined exercise, Postmenopausal women, Heart rate variability, Cardiac autonomic function, Menopausal symptoms, Sleep quality, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Structured Combined Exercise ProgramParticipants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Combined Exercise ProgramThe 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. | Behavioural | Exercise Group |
Primary outcome
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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Results publication: PubMed 41430672Yilmaz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Combined Exercise Program in people with Postmenopausal and Menopausal Symptoms, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Akkurt, PhD (+90 553 604 6713, burcu.akkurt@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline, immediately after the 12-week intervention, and 8 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07615790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.