Foot and Ankle Strengthening Program to Improve Physical Function in Menopausal Women

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Physical Function; Musculoskeletal Function
• Intervention / Treatment: Other: Foot and ankle exercise program

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge García Medina; Phone Number: +34 684 10 52 97; Email: jorgegarcia98@uma.es
• Study Contact Backup: Name: Ana Marchena Rodríguez, PhD; Phone Number: +34 951953488; Email: amarchena@uma.es

Study Locations

• Spain
  • Andalusia
    • Málaga, Andalusia, Spain, 29071
      • Faculty of Health Sciences, University of Málaga
      • Contact: Jorge García Medina; Phone Number: +34 684 10 52 97; Email: jorgegarcia98@uma.es
      • Contact: Ana Marchena Rodríguez, PhD; Phone Number: +34 951953488; Email: amarchena@uma.es
      • Principal Investigator: Ana Marchena Rodríguez, PhD
      • Sub-Investigator: Jorge Garcia Medina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; 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; 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	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.	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.	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.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Malaga

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JorGar138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No