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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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.

Первичные конечные точки

• Isometric plantarflexion strength of the ankle [Срок оценки: Baseline and 12 weeks]

Вторичные конечные точки (7)

• Isometric ankle strength in dorsiflexion, inversion and eversion [Срок оценки: Baseline and 12 weeks]
• Intrinsic foot muscle strength and function [Срок оценки: Baseline and 12 weeks]
• Walking speed [Срок оценки: Baseline and 12 weeks]
• Spatiotemporal gait parameters [Срок оценки: Baseline and 12 weeks]
• Static balance [Срок оценки: Baseline and 12 weeks]
• Foot and ankle functional status [Срок оценки: Baseline and 12 weeks]
• Health-related quality of life [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Faculty of Health Sciences, University of Málaga — Málaga

Публикации

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• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07472205 · JorGar138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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