Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women (NCT07472205) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women
Spain70 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged between 45 and 65 years.
* Postmenopausal status defined as at least 12 consecutive months of amenorrhea.
* Low or moderate physical activity level assessed using the International Physical Activity Questionnaire (IPAQ).
* Ability to understand study instructions and complete questionnaires in Spanish.
* Willingness to participate in the study and sign informed consent.
Exclusion Criteria:
* Neurological disorders affecting gait or motor control.
* Lower limb surgery within the previous 6 months.
* Active painful pathology of the foot or ankle that could interfere with the intervention or measurements.
* Cognitive impairment limiting understanding or execution of the protocol.
* Current participation in specific foot or ankle strengthening programs.
* Habitual vigorous physical activity or participation in structured lower limb strength training programs within the previous three months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.