An interventional study of Foot and ankle exercise program in Menopause, Musculoskeletal Function and Physical Function, sponsored by University of Malaga. Not yet recruiting at 1 site in Spain. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
Menopause 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.
Approximately 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.
The 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.
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.
Exercise 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.
This 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.
Approximately 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.
The 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.
Assessments 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.
The 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
University of Malaga is the lead sponsor of 121 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Foot and ankle exercise program
Participants assigned to the control group will maintain their usual physical activity without performing the structured exercise program during the study period.
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.
Isometric plantarflexion strength of the ankle
Maximal isometric plantarflexion strength of the ankle measured using hand-held dynamometry. Participants 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).
Time frame: Baseline and 12 weeks
Isometric ankle strength in dorsiflexion, inversion and eversion
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.
Time frame: Baseline and 12 weeks
Intrinsic foot muscle strength and function
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.
Time frame: Baseline and 12 weeks
Walking speed
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).
Time frame: Baseline and 12 weeks
Spatiotemporal gait parameters
Spatiotemporal gait parameters including step length, stride length, cadence and stance time measured using the OptoGait system (Microgate, Bolzano, Italy).
Time frame: Baseline and 12 weeks
Static balance
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.
Time frame: Baseline and 12 weeks
Change in dynamic balance assessed with the modified Star Excursion Balance Test (mSEBT)
Dynamic balance will be assessed using the modified Star Excursion Balance Test (mSEBT), performed in three reach directions: anterior, posteromedial, and posterolateral. Participants will maintain single-leg stance while reaching as far as possible with the contralateral limb in each direction. Reach distance will be recorded and normalized to limb length using the formula: normalized reach distance (%) = reach distance / limb length × 100. A composite score will also be calculated as: \[(anterior + posteromedial + posterolateral reach distances) / (3 × limb length)\] × 100. Higher normalized and composite scores indicate better dynamic balance performance.
Time frame: Baseline and 12 weeks
Foot and ankle functional status
Self-reported foot and ankle function assessed using the Foot and Ankle Ability Measure \- Activities of Daily Living subscale (FAAM-ADL). Scores are expressed as a percentage from 0 to 100%, where higher scores indicate better function.
Time frame: Baseline and 12 weeks
Health-related quality of life
Health-related quality of life assessed using the EuroQol-5D questionnaire, including the EQ-5D index and the EQ-VAS scale.
Time frame: Baseline and 12 weeks
Plan to share: Undecided — 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.
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