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

Fall Risk Clinical Trial

— STIFF3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531136
• Other study ID #: STIFF 3
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Fontys University of Applied Sciences
• Contact: Lydia Willemse, MSc
• Phone: +31646081601
• Email: lydia.willemse[@]fontys.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall Risk

Intervention

Other:
• 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

Locations

Country	Name	City	State
Netherlands	Fontys Hogeschool	Eindhoven

Sponsors (4)

Lead Sponsor	Collaborator
Lydia Willemse	Fontys University of Applied Sciences, KU Leuven, Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum gait speed	The post-intervention difference between the intervention and control group in maximum gait speed.	12 weeks
Secondary	Foot muscles' morphology derived from ultrasound imaging		12 weeks
Secondary	Lower extremity biomechanics during gait assessed with 3D motion and ground reaction force capturing		12 weeks
Secondary	Spatiotemporal gait parameters assessed with 3D motion and ground reaction force capturing		12 weeks
Secondary	Balance during gait assessed with 3D motion and ground reaction force capturing		12 weeks
Secondary	Self-reported mobility limitations		12 weeks
Secondary	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	12 weeks
Secondary	Fall incidents during the intervention		12 weeks
Secondary	Fear of falling assessed by the (Falls Efficacy Scale-International) FES-I questionnaire		12 weeks
Secondary	Foot plantar pressure during gait assessed by a 2-meter pressure plate		12 weeks
Secondary	Static balance assessed by a force plate during single leg stance		12 weeks
Secondary	Isometric toe flexor strength assessed by a pressure plate during maximal toe press		12 weeks
Secondary	Physical functioning assessed by the Short Physical Performance Battery (SPPB)		12 weeks
Secondary	Foot arch characteristics assessed by a 3D foot scanner		12 weeks
Secondary	Health related quality of life assessed by SF-36		12 weeks