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

NCT07615790 | Recruiting

• 1 other identifier: 39.2026fbu
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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).

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

Secondary Outcomes (5)

• Menopause Rating Scale

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

• Sleep Quality

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

• Menopause-Specific Quality of Life

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

• Depressive Symptoms

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

• Hot Flash Frequency and Severity

  Daily throughout the 12-week intervention period and daily during the 8-week post-intervention follow-up period

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants will receive a 12-week structured combined exercise program performed twice weekly under physiotherapist supervision.

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.

Interventions

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.

Exercise Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahce University

Istanbul, Atasehir, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Autonomic Nervous System Diseases; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Burcu Akkurt, PhD

CONTACT

+90 553 604 6713; burcu.akkurt@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 29, 2026
• Study Start: April 27, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

TU (1)