Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults

NCT ID: NCT05531136

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2024-07-18

Brief Summary

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.

Conditions

Fall Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Foot strengthening training

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.

Group Type: EXPERIMENTAL

Foot strengthening training

Intervention Type: OTHER

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

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Foot strengthening training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• be 65 years of age or over;
• be able to ambulate 10 meter without using a walking aid;
• engage in a functional exercise program delivered to a group of older adults by an educated or certified physical therapist or trainer (e.g., fall preventive exercise program, senior fit programs);
• report to have 1) fear of falling OR 2) experienced a fall in the previous 12 months OR 3) difficulties with mobility, gait, or balance;
• be able to arrange their own transport to the movement analysis laboratory.

Exclusion Criteria

• The respondent is a minor or legally incompetent adult;
• Self-reported presence of any disorder interfering with the execution of the exercises.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fontys University of Applied Sciences

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Tilburg University

OTHER

Sponsor Role: collaborator

Lydia Willemse

OTHER

Sponsor Role: lead

Responsible Party

Lydia Willemse

MSc.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fontys Hogeschool

Eindhoven, , Netherlands

Countries

Netherlands

References

Willemse L, Wouters EJM, Pisters MF, Vanwanseele B. Effects of a 12-week intrinsic foot muscle strengthening training (STIFF) on gait in older adults: a parallel randomized controlled trial protocol. BMC Sports Sci Med Rehabil. 2024 Jul 20;16(1):158. doi: 10.1186/s13102-024-00944-z.

Reference Type: DERIVED

PMID: 39033125 (View on PubMed)

Other Identifiers

STIFF 3

Identifier Type: -

Identifier Source: org_study_id