Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women (FAMEX)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversity of Malaga
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Foot and ankle exercise program
Other interventionA 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Exercise groupExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: