- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471620
The Effect of High Intensity Functional Exercise Programs on Menopausal Symptoms, Physical Performance, and Dual Task Performance in Postmenopausal Women (HIFT-PM)
The Effect of High-Intensity Functional Exercise Programs on Menopausal Symptoms, Physical Performance, and Dual-Task Performance in Postmenopausal Women
This study was conducted to examine the effects of exercise programs on the physical and psychosocial health of postmenopausal women. The postmenopausal period is characterized by an increased risk of problems such as decreased muscle strength, balance problems, fatigue, stress, and reduced quality of life due to hormonal changes. Therefore, appropriate exercise approaches are crucial during this period.
The study evaluated the effects of regular and planned exercise programs on the physical functions and overall well-being of postmenopausal women.
The study also addressed structured exercise approaches such as high-intensity functional training (HIFT). HIFT consists of short but intense exercises similar to daily activities. However, such exercises should be planned and monitored by healthcare professionals according to the individual's age and health status.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Üsküdar Üniversitesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participant must have had at least 12 months pass since their last menstrual period.
- The participant must be between 50-65 years of age.
- The participant must be able to walk independently.
- The participant must have sufficient cognitive function.
Exclusion Criteria:
- Neurological disorders
- Active vestibular disorder
- Lower extremity surgery or serious orthopedic injury
- Severe arthritis and pain affecting walking
- Use of sedative psychoactive drugs
- Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Functional Training Group
group that performs high-intensity functional exercises
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Participants in the exercise group followed a high-intensity functional exercise program designed to improve physical function, menopausal symptoms, and dual-task performance during the postmenopausal period.
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|
Active Comparator: Control Group
moderate to low intensity exercise
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Control group participants performed moderate or low-intensity exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
short physical performance battery
Time Frame: 8 weeks
|
Short Physical Performance Battery (SPPB) is a brief and standardized test battery used to assess lower-extremity physical performance, particularly in older adults. The test evaluates three main functional components: balance, gait speed, and chair-stand performance. Each subtest is scored between 0 and 4 points, resulting in a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used in clinical research and geriatric assessments to determine functional capacity, risk of falls, and level of physical independence. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual task performance
Time Frame: 8 weeks
|
Dual-task performance refers to an individual's ability to perform two tasks simultaneously.
It is commonly assessed by combining a motor task (such as walking) with a cognitive task (such as counting or word generation) at the same time.
This assessment is widely used to examine cognitive-motor interaction, balance control, and fall risk, particularly in older adults.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Filiz Eyuboglu, PhD, Uskudar University
- Principal Investigator: Nazlı H Gözütok, Uskudar University
Publications and helpful links
General Publications
- Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.
- Crawford DA, Drake NB, Carper MJ, DeBlauw J, Heinrich KM. Are Changes in Physical Work Capacity Induced by High-Intensity Functional Training Related to Changes in Associated Physiologic Measures? Sports (Basel). 2018 Mar 27;6(2):26. doi: 10.3390/sports6020026.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 61351342/020-1603
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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