Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:31 PM
Study NCT ID:
NCT07472205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blinded to group allocation. Participants will be instructed not to disclose their group assignment during the assessment sessions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to either a structured foot and ankle exercise program or a control group maintaining their usual physical activity. The intervention will last 12 weeks and outcomes will be assessed before and after the intervention period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isometric plantarflexion strength of the ankle', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Maximal isometric plantarflexion strength of the ankle measured using hand-held dynamometry.\n\nParticipants will perform maximal voluntary contractions in a standardized seated position with the knee flexed at 90° and the ankle in neutral position. Two trials of 3-5 seconds will be performed and the highest value will be recorded. Strength will be expressed in kilograms (Kg).'}], 'secondaryOutcomes': [{'measure': 'Isometric ankle strength in dorsiflexion, inversion and eversion', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Maximal isometric strength of ankle dorsiflexors, invertors and evertors measured using hand-held dynamometry under standardized conditions. Two maximal contractions will be performed for each movement and the highest value will be recorded.'}, {'measure': 'Intrinsic foot muscle strength and function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Intrinsic foot muscle function assessed through a standardized battery including toe flexor strength, the paper grip test, navicular drop test and the single-leg heel raise test. These tests evaluate the functional capacity and endurance of intrinsic foot muscles.'}, {'measure': 'Walking speed', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Walking speed assessed on a treadmill under two conditions: comfortable walking speed and maximal safe walking speed. Participants will walk for 60 seconds and the final velocity will be recorded in meters per second (m/s).'}, {'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Spatiotemporal gait parameters including step length, stride length, cadence and stance time measured using the OptoGait system (Microgate, Bolzano, Italy).'}, {'measure': 'Static balance', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Static balance assessed using the Single Leg Stance Test. Participants will stand on one leg with eyes open and the maximum time maintaining balance will be recorded.'}, {'measure': 'Foot and ankle functional status', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Self-reported foot and ankle function assessed using the Foot and Ankle Ability Measure\n\n\\- Activities of Daily Living subscale (FAAM-ADL). Scores are expressed as a percentage from 0 to 100%, where higher scores indicate better function.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Health-related quality of life assessed using the EuroQol-5D questionnaire, including the EQ-5D index and the EQ-VAS scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause', 'Musculoskeletal Function', 'Physical Function']}, 'referencesModule': {'references': [{'pmid': '28886865', 'type': 'BACKGROUND', 'citation': 'Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.'}, {'pmid': '17448732', 'type': 'BACKGROUND', 'citation': 'Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007 Sep-Oct;7(5):541-6. doi: 10.1016/j.spinee.2007.01.008. Epub 2007 Apr 2.'}, {'pmid': '38393976', 'type': 'BACKGROUND', 'citation': 'Wasley D, Gailey S. Menopause and the role of physical activity - The views and knowledge of women aged 40-65. Post Reprod Health. 2024 Jun;30(2):77-84. doi: 10.1177/20533691241235273. Epub 2024 Feb 23.'}, {'pmid': '38350040', 'type': 'BACKGROUND', 'citation': 'Tomaz GG, Souza MVC, Carneiro MADS, Lima ML, Assumpcao CO, Orsatti FL. Propulsive forces and muscle activation during gait: comparisons between premenopausal and postmenopausal midlife women. Menopause. 2024 Mar 1;31(3):194-201. doi: 10.1097/GME.0000000000002318. Epub 2024 Feb 13.'}, {'pmid': '33230535', 'type': 'BACKGROUND', 'citation': 'Bondarev D, Finni T, Kokko K, Kujala UM, Aukee P, Kovanen V, Laakkonen EK, Sipila S. Physical Performance During the Menopausal Transition and the Role of Physical Activity. J Gerontol A Biol Sci Med Sci. 2021 Aug 13;76(9):1587-1590. doi: 10.1093/gerona/glaa292.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will evaluate the effects of a 12-week foot and ankle strengthening program on physical function and health-related quality of life in menopausal women.\n\nMenopause is associated with hormonal changes that may negatively affect muscle strength, balance, and functional capacity, potentially leading to reduced mobility and increased risk of falls. Although exercise interventions have demonstrated benefits in this population, most programs focus on global lower-limb training and rarely target the foot and ankle complex, which plays a key role in postural stability and gait propulsion.\n\nApproximately 60 menopausal women aged 45-65 years will be randomly assigned to either an intervention group performing a structured foot and ankle strengthening program or a control group maintaining their usual physical activity. The intervention will last 12 weeks and will include one supervised weekly session and four home-based sessions.\n\nThe primary outcome will be ankle plantarflexion isometric strength measured by hand-held dynamometry. Secondary outcomes will include ankle strength in other directions, intrinsic foot muscle function, gait speed, spatiotemporal gait parameters, balance, foot-related functional status, and health-related quality of life.', 'detailedDescription': 'Menopause represents a physiological transition characterized by a progressive decline in estrogen and other sex hormones. These hormonal changes influence musculoskeletal health and may lead to reductions in muscle strength, impaired neuromuscular control, decreased balance capacity, and increased risk of functional decline. Such alterations may negatively affect mobility and quality of life in midlife and older women.\n\nExercise is widely recognized as an effective non-pharmacological strategy to mitigate the negative musculoskeletal consequences associated with menopause. Previous studies have demonstrated improvements in muscle strength, balance, gait speed, and overall physical function following exercise interventions in this population. However, most interventions focus on global lower limb training and rarely include specific exercises targeting the foot and ankle complex, despite its crucial role in postural control, propulsion during gait, and load distribution.\n\nThis randomized controlled trial will evaluate the effectiveness of a structured foot and ankle strengthening program in menopausal women. The study will use a parallel two-group design with blinded outcome assessors and a 1:1 allocation ratio. Participants will be randomly assigned to either an intervention group or a control group.\n\nApproximately 60 women aged between 45 and 65 years who meet the clinical definition of menopause and have low to moderate physical activity levels will be recruited from the University of Málaga and the surrounding community. After baseline assessment, participants will be randomly allocated to the intervention or control group using a computer-generated randomization sequence with permuted blocks.\n\nThe intervention will consist of a 12-week progressive exercise program specifically designed to strengthen intrinsic and extrinsic foot muscles, improve ankle function, enhance neuromuscular control, and promote functional capacity of the lower limb. Participants in the intervention group will perform one supervised weekly session at the University of Málaga and four home-based exercise sessions per week. The control group will maintain their usual physical activity without participating in the exercise program.\n\nAssessments will be conducted at baseline and after the 12-week intervention period by evaluators blinded to group allocation. Outcome measures will include isometric ankle strength measured by hand-held dynamometry, intrinsic foot muscle function tests, gait speed and spatiotemporal gait parameters measured using the OptoGait® system, balance performance assessed by the Single-Leg Stance Test, self-reported foot function using the Foot and Ankle Ability Measure (FAAM-ADL), and health-related quality of life measured with the EuroQol-5D questionnaire.\n\nThe findings of this trial will contribute to understanding the role of targeted distal strengthening interventions in improving functional capacity and mobility in menopausal women and may support the development of clinically applicable exercise programs for this population'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged between 45 and 65 years.\n* Postmenopausal status defined as at least 12 consecutive months of amenorrhea.\n* Low or moderate physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).\n* Ability to understand study instructions and complete questionnaires in Spanish.\n* Willingness to participate in the study and sign informed consent.\n\nExclusion Criteria:\n\n* Neurological disorders affecting gait or motor control.\n* Lower limb surgery within the previous 6 months.\n* Active painful pathology of the foot or ankle that could interfere with the intervention or measurements.\n* Cognitive impairment limiting understanding or execution of the protocol.\n* Current participation in specific foot or ankle strengthening programs.\n* Habitual vigorous physical activity or participation in structured lower limb strength training programs within the previous three months.'}, 'identificationModule': {'nctId': 'NCT07472205', 'briefTitle': 'Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaga'}, 'officialTitle': 'Randomized Clinical Trial of the Effects of a 12-Week Foot and Ankle Strengthening Program on Physical Function and Quality of Life in Menopausal Women', 'orgStudyIdInfo': {'id': 'JorGar138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Participants will perform a structured foot and ankle exercise program designed to improve muscle strength, balance, and functional performance. The intervention will last 12 weeks and will include exercises targeting intrinsic and extrinsic foot muscles, ankle stabilizers, and functional balance tasks.', 'interventionNames': ['Other: Foot and ankle exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Participants assigned to the control group will maintain their usual physical activity without performing the structured exercise program during the study period.'}], 'interventions': [{'name': 'Foot and ankle exercise program', 'type': 'OTHER', 'description': 'A structured exercise program focused on strengthening intrinsic and extrinsic foot muscles, ankle stabilizers, and improving balance and functional performance. The program will be performed over a 12-week period.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29071', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'contacts': [{'name': 'Ana Marchena Rodríguez, PhD', 'role': 'CONTACT', 'email': 'amarchena@uma.es', 'phone': '+34 951953488'}, {'name': 'Jorge García Medina', 'role': 'CONTACT', 'email': 'jorgegarcia98@uma.es', 'phone': '+34 684 10 52 97'}, {'name': 'Ana Marchena Rodríguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jorge Garcia Medina', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Health Sciences, University of Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'centralContacts': [{'name': 'Jorge García Medina', 'role': 'CONTACT', 'email': 'jorgegarcia98@uma.es', 'phone': '+34 684 10 52 97'}, {'name': 'Ana Marchena Rodríguez, PhD', 'role': 'CONTACT', 'email': 'amarchena@uma.es', 'phone': '+34 951953488'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The plan to share individual participant data has not yet been determined. Data sharing policies will be evaluated after study completion in accordance with institutional policies and applicable data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaga', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Jorge García Medina', 'investigatorAffiliation': 'University of Malaga'}}}}