Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults (STIFF3)

Lydia Willemse

Status: Terminated

Conditions: Fall Risk

Treatments: Other: Foot strengthening training

Study type: Interventional

Funder types: Other

Identifiers

NCT05531136

STIFF 3

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Foot strengthening training

Experimental group

Description:

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.

Treatment:

Other: Foot strengthening training

Control

No Intervention group

Description:

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.