Effects of a 12-week intrinsic foot muscle strengthening training (STIFF) on gait in older adults: a parallel randomized controlled trial protocol.

Background: Falling is highly prevalent among older adults and has serious impact. Age-induced mobility impairments, such as gait modifications, are strongly associated with increased fall risk. Among fall prevention interventions, those including exercises are most effective. However, there is an urgent need to further improve these kinds of interventions. Strengthening the plantar intrinsic foot muscles might benefit mobility in older adults, which may contribute to the reduction of fall risk. The aim of this paper is to provide a protocol to investigate the effect of a plantar intrinsic foot muscle strengthening training versus no training on gait and intrinsic foot muscle function in older adults who are involved in a functional exercise program.

Methods: For this assessor-blinded RCT, older adults (> 65 years) are recruited who are involved in a group-based functional exercise program. Eligibility criteria include: being able to ambulate 10 m barefoot without using a walking aid and reporting to have either fear of falling or experienced a fall in the previous 12 months or have difficulties with mobility, gait, or balance in daily life. Participants are randomly assigned to an intervention and a control group. The intervention group follows a 12-week plantar intrinsic foot muscle strengthening training. The training consists of isolated and functional foot exercises to be performed 5 times a week, each session lasting approximately 20 min. The training is supervised once a week and the intensity gradually increases based on the participant's progression. Both groups keep a diary to report physical activities, fall incidents and movement related discomfort. The control condition is limited to keeping this diary. Data are collected at baseline and post-intervention. The trial outcomes are the between group differences in the mean change from baseline in maximum gait speed (primary outcome measure), capacity and strength of the plantar intrinsic foot muscles, foot and ankle biomechanics during gait, and various other fall risk-related variables. ANCOVA's are used to analyze the trial outcomes.

Discussion: The results of this RCT will offer recommendations, related to plantar intrinsic foot muscle strengthening, to existing fall preventive exercise programs.

Trial registration: The trial is registered in the United States National Library of Medicine through ClinicalTrials.gov (NCT05531136, 07/26/2022).