Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:37 AM
Study NCT ID:
NCT07471620
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of High Intensity Functional Exercise Programs on Menopausal Symptoms, Physical Performance, and Dual Task Performance in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A two-group parallel intervention model was applied, with exercise and control groups monitored simultaneously.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'short physical performance battery', 'timeFrame': '8 weeks', 'description': '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.\n\nEach 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.'}], 'secondaryOutcomes': [{'measure': 'Dual task performance', 'timeFrame': '8 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dual task, postmenopause, high intensity functional training'], 'conditions': ['Postmenopausal Period']}, 'referencesModule': {'references': [{'pmid': '30087252', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29910330', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe study evaluated the effects of regular and planned exercise programs on the physical functions and overall well-being of postmenopausal women.\n\nThe 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.", 'detailedDescription': "Menopause is a natural process that occurs with the end of a woman's reproductive years, and due to hormonal changes, many physiological, psychological, and functional symptoms are observed. During this period, decreased estrogen levels are associated with sleep disturbances, vasomotor symptoms, fatigue, depressive mood, musculoskeletal complaints, and a significant decrease in quality of life. Exercise is one of the most effective, low-cost, and safe methods to alleviate menopausal symptoms and improve functionality. However, studies investigating the effects of HIFT on menopausal symptoms, physical performance, and dual-task performance in postmenopausal women are quite limited."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant must have had at least 12 months pass since their last menstrual period.\n* The participant must be between 50-65 years of age.\n* The participant must be able to walk independently.\n* The participant must have sufficient cognitive function.\n\nExclusion Criteria:\n\n* Neurological disorders\n* Active vestibular disorder\n* Lower extremity surgery or serious orthopedic injury\n* Severe arthritis and pain affecting walking\n* Use of sedative psychoactive drugs\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT07471620', 'acronym': 'HIFT-PM', 'briefTitle': 'The Effect of High Intensity Functional Exercise Programs on Menopausal Symptoms, Physical Performance, and Dual Task Performance in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'The Effect of High-Intensity Functional Exercise Programs on Menopausal Symptoms, Physical Performance, and Dual-Task Performance in Postmenopausal Women', 'orgStudyIdInfo': {'id': '61351342/020-1603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Functional Training Group', 'description': 'group that performs high-intensity functional exercises', 'interventionNames': ['Behavioral: High-intensity functional exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'moderate to low intensity exercise', 'interventionNames': ['Behavioral: moderate to low intensity exercise']}], 'interventions': [{'name': 'High-intensity functional exercise', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['High Intensity Functional Training Group']}, {'name': 'moderate to low intensity exercise', 'type': 'BEHAVIORAL', 'description': 'Control group participants performed moderate or low-intensity exercise.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Üsküdar Üniversitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Filiz Eyüboğlu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uskudar University'}, {'name': 'Nazlı H Gözütok', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}