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

NCT07472205 | Not Yet Recruiting

• 1 other identifier: JorGar138
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Musculoskeletal Function; Physical Function

Outcome Measures

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).

  Baseline and 12 weeks

Secondary Outcomes (7)

• Isometric ankle strength in dorsiflexion, inversion and eversion

  Baseline and 12 weeks

• Intrinsic foot muscle strength and function

  Baseline and 12 weeks

• Walking speed

  Baseline and 12 weeks

• Spatiotemporal gait parameters

  Baseline and 12 weeks

• Static balance

  Baseline and 12 weeks

Study Arms (2)

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.

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.

Interventions

Foot and ankle exercise program OTHER

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.

Exercise group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Faculty of Health Sciences, University of Málaga

Málaga, Andalusia, 29071, Spain

Location

Related Publications (5)

• 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.

  PMID: 28886865 BACKGROUND

• 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.

  PMID: 17448732 BACKGROUND

• 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.

  PMID: 38393976 BACKGROUND

• 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.

  PMID: 38350040 BACKGROUND

• 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.

  PMID: 33230535 BACKGROUND

Central Study Contacts

Jorge García Medina

CONTACT

+34 684 10 52 97; jorgegarcia98@uma.es

Ana Marchena Rodríguez, PhD

CONTACT

+34 951953488; amarchena@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Participants will be instructed not to disclose their group assignment during the assessment sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

ES (1)