NCT06868134

Brief Summary

This study aims to evaluate the effectiveness of different exercise methods in improving health outcomes for postmenopausal women. As women go through menopause, they may experience changes such as decreased bone density, muscle weakness, and an increased risk of chronic diseases. Exercise is known to be beneficial in reducing these risks, but the best approach remains unclear. In this clinical trial, participants will engage in structured exercise programs designed to improve bone health, strength, and overall well-being. The study will compare different types of exercises to determine which method provides the most benefits. By participating in this research, postmenopausal women can contribute to a better understanding of how exercise can enhance health during this stage of life. This study is safe, and all exercises are guided by professionals. The results will help healthcare providers recommend the most effective exercise strategies for postmenopausal women.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 5, 2025

Last Update Submit

March 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Composition (Fat Mass, Lean Mass, and BMI) Assessed by Bioelectrical Impedance Analysis (BIA)

    Body composition (fat mass, lean mass, and BMI) measured using bioelectrical impedance analysis (BIA). Higher fat mass may be associated with lower exercise capacity.

    Baseline and Week 8

Secondary Outcomes (5)

  • Menopause Symptom Assessment Scale Score

    Baseline and Week 8

  • Fatigue Severity Scale Score

    Baseline and Week 8

  • Beck Depression Inventory (BDI) Score

    Baseline and Week 8

  • Pittsburgh Sleep Quality Index (PSQI) Score

    Baseline and Week 8

  • Short Form-36 (SF-36) Quality of Life Scale Score

    Baseline and Week 8

Study Arms (3)

Control Group

NO INTERVENTION

Participants in this group will not receive any intervention

Supervised Exercise Group

EXPERIMENTAL

Participants in this group will receive a supervised progressive exercise program including stretching, strengthening, and aerobic exercises. The intervention will be performed 3 times per week with at least one rest day between sessions.

Behavioral: Supervised Progressive Exercise Program

Web-Based Exercise Group

EXPERIMENTAL

Participants in this group will follow a progressive exercise program through the Physitrack web platform. At the beginning and at the end of the 8th week, participants will be assessed. A profile will be created for each participant by the researcher, and the individualized progressive exercise program will be assigned to their profiles. The intervention will be performed 3 times per week with at least one rest day between sessions.

Behavioral: Web-Based Exercise Group

Interventions

Participants will follow a structured progressive exercise program through the Physitrack web platform, including stretching, strengthening, and aerobic exercises. The program will be assigned to each participant's profile, and they will complete the exercises three times per week with at least one rest day between sessions. Assessments will be conducted at the beginning and at the end of the 8th week.

Web-Based Exercise Group

Participants in this group will receive a supervised progressive exercise program consisting of stretching, strengthening, and aerobic exercises. The intervention will be conducted three times per week with at least one rest day between sessions.

Supervised Exercise Group

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details12 months of amenore
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 40-65 years of age Having a Body Mass Index (BMI) below 40 Scoring 68 or above on the System Usability Scale Having no orthopedic problems Completing the informed consent form Being within 5 years after a 12-month amenorrhea history

You may not qualify if:

  • Presence of visual impairments Presence of musculoskeletal system disorders Presence of cognitive impairments Presence of joint range of motion limitations Presence of severe cardiac problems Participation in another program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 10, 2025

Study Start

August 10, 2023

Primary Completion

August 20, 2024

Study Completion

March 30, 2025

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations