Menopause(FAMEX)NCT07472205
Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women (FAMEX)
A study testing Foot and ankle exercise program in people with Menopause and Musculoskeletal Function, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Musculoskeletal Function, Physical Function
- What is being tested?
- Foot and ankle exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Faculty of Health Sciences, University of Málaga
Málaga, Andalusia, 29071
Ana Marchena Rodríguez, PhD, +34 951953488, amarchena@uma.es
Jorge García Medina, +34 684 10 52 97, jorgegarcia98@uma.es
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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
- Conditions
- Menopause, Musculoskeletal Function, Physical Function
- Being tested
- Foot and ankle exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot and ankle exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Foot and ankle exercise program |
| No intervention | No intervention | Participants assigned to the control group will maintain their usual physical activity without performing the structured exercise program during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge García Medina, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472205
- Sponsor's protocol ID
- JorGar138
- Acronym
- (FAMEX)
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 28886865Copay 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.
PubMed 17448732Wasley 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.
PubMed 38393976Tomaz 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.
PubMed 38350040Bondarev 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.
PubMed 33230535
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07472205
- Acronym / sponsor ID
- (FAMEX) / JorGar138
- Conditions
- Menopause, Musculoskeletal Function, Physical Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Foot and ankle exercise programParticipants 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. |
| No intervention | No intervention | –Participants assigned to the control group will maintain their usual physical activity without performing the structured exercise program during the study period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot and ankle exercise programA 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. | Other | Exercise group |
Primary outcome
Isometric plantarflexion strength of the ankle
Time frame: Baseline and 12 weeks
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).
8 secondary outcomes
Isometric ankle strength in dorsiflexion, inversion and eversion
Time frame: Baseline and 12 weeks
Intrinsic foot muscle strength and function
Time frame: Baseline and 12 weeks
Walking speed
Time frame: Baseline and 12 weeks
Spatiotemporal gait parameters
Time frame: Baseline and 12 weeks
Static balance
Time frame: Baseline and 12 weeks
Change in dynamic balance assessed with the modified Star Excursion Balance Test (mSEBT)
Time frame: Baseline and 12 weeks
Foot and ankle functional status
Time frame: Baseline and 12 weeks
Health-related quality of life
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 28886865Hebert-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.
- Background: PubMed 17448732Copay 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.
- Background: PubMed 38393976Wasley 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.
- Background: PubMed 38350040Tomaz 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.
- Background: PubMed 33230535Bondarev 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot and ankle exercise program in people with Menopause and Musculoskeletal Function, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge García Medina (+34 684 10 52 97, jorgegarcia98@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric plantarflexion strength of the ankle (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07472205, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.