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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Malaga
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Isometric plantarflexion strength of the ankle
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors will be blinded to group allocation. Participants will be instructed not to disclose their group assignment during the assessment sessions.
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Foot and ankle exercise program (Other)
No intervention
Participants assigned to the control group will maintain their usual physical activity without performing the structured exercise program during the study period.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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)
- Foot and ankle functional status(Baseline and 12 weeks)
- Health-related quality of life(Baseline and 12 weeks)
- Change in dynamic balance assessed with the modified Star Excursion Balance Test (mSEBT)(Baseline and 12 weeks)
Investigators
Jorge García Medina
PhD Candidate
University of Malaga