An interventional study of Foot strengthening training in Fall Risk, sponsored by Lydia Willemse. Terminated at 1 site in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Lydia Willemse · Not applicable, Interventional, and Prevention
Background of the study:
Falling is highly prevalent among older adults and has serious societal impact. Falls occur mainly during walking as a result of altered gait and/or the inability to maintain balance. The plantar intrinsic foot muscles (PIFM) have a role in these dynamic functions. When these muscles atrophy, as happens with advancing age, strengthening these muscles may be beneficial in order to improve or retain gait performance.
Objective of the study:
To investigate the effect of adding PIFM strengthening exercises to fall prevention programs compared to fall prevention programs alone on maximum gait speed in mobile older adults. The secondary objective is to also investigate the effect on: foot muscles' size, foot function during gait, balance during gait, discomfort during or after the training, self-reported mobility limitations, physical activity level, fall incidents during the intervention, fear of falling, foot plantar pressure during gait, static balance, toe flexor strength, physical functioning, foot morphology, foot posture.
Study design:
An investigator-blinded parallel randomized controlled trial (RCT), with a 12-week PIFM strengthening intervention period and pre- and post-intervention laboratory measurements.
Study population:
Older adults (>65 years) who are free of any known condition or disease that interferes with the execution of the exercise program.
Intervention:
Both the control and the intervention group continue with the regular exercise therapy to prevent falling. On top of this, the intervention group is delivered a 12-weeks exercise program consisting of foot strengthening exercises prescribed for 5 daily sessions a week, of which 1 supervised, 20 minutes per session.
Primary study parameters/outcome of the study:
The post-intervention difference between the intervention and control group in maximum gait speed.
Secondary study parameters/outcome of the study:
The post-intervention difference between the intervention and control group in foot muscles' size, foot function during gait, balance during gait, discomfort during or after the training, self-reported mobility limitations, physical activity level, fall incidents during the intervention, fear of falling, foot plantar pressure during gait, static balance, toe flexor strength, physical functioning, foot morphology, foot posture.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden for the participant consists mainly of 1) the time spent and effort put in engaging in the exercise therapy, 2) any discomfort (e.g., fatigue) or pain (e.g., cramp, muscle soreness) during or after the exercises, 3) the time that is spent on the measurement occasions (home visits: 1 x 1 hour (+ 1 x 30 minutes for the intervention group); laboratory: 2 x 3 hours), 4) the necessity of travelling to the motion analysis laboratory, 5) the inconvenience of wearing the activity monitor attached to the skin of the thigh for 7 days, and 6) questionnaires may unintentionally make the subject aware of declined health conditions.
This is the only study on the registry with Lydia Willemse as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria::
12-week foot strengthening training in addition to an already joined functional exercise program. The foot strengthening training is supervised and progressing and consists of isolated and functional exercises. Participants keep a training diary.
Other: Foot strengthening training
The control group continues the functional exercise program as usual. The subjects in this group are asked to keep a diary in which the subjects weekly report other physical activities, fall incidents and mobility related discomfort. The trainer calls the participants in the control group every week to pay attention to these topics.
a 12-weeks exercise program consisting of foot strengthening exercises prescribed for 5 daily sessions a week, of which 1 supervised, 20 minutes per session on top of the regular exercise therapy to prevent falling
Maximum gait speed
The post-intervention difference between the intervention and control group in maximum gait speed.
Time frame: 12 weeks
Foot muscles' morphology derived from ultrasound imaging
Time frame: 12 weeks
Lower extremity biomechanics during gait assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Spatiotemporal gait parameters assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Balance during gait assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Self-reported mobility limitations
Time frame: 12 weeks
Weekly time spent in physical activities
in bouts of at least 10 minutes duration that is experienced by the participant at least as moderate intense (≥5 on a 10-point scale of how hard one feel he or she is exercising). From this it is deduced whether the participant meets the WHO recommendation on aerobic physical activity for health
Time frame: 12 weeks
Fall incidents during the intervention
Time frame: 12 weeks
Fear of falling assessed by the (Falls Efficacy Scale-International) FES-I questionnaire
Time frame: 12 weeks
Foot plantar pressure during gait assessed by a 2-meter pressure plate
Time frame: 12 weeks
Static balance assessed by a force plate during single leg stance
Time frame: 12 weeks
Isometric toe flexor strength assessed by a pressure plate during maximal toe press
Time frame: 12 weeks
Physical functioning assessed by the Short Physical Performance Battery (SPPB)
Time frame: 12 weeks
Foot arch characteristics assessed by a 3D foot scanner
Time frame: 12 weeks
Health related quality of life assessed by SF-36
Time frame: 12 weeks
Plan to share: Undecided — Re-use of the data will be on request and on condition that all Principle Investigators agree and provided the requirements of the ethical committee are met
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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