Clinical trial NCT05531136: Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults
Official title: Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fall Risk
Keywords: falling
foot exercises
older adults
mobility
Lead sponsor: Fontys University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Fontys University of Applied Sciences
name: KU Leuven
name: Tilburg University
First posted: 2022-09-07
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is an assessor-blinded RCT with two parallel groups. Participants are randomly assigned in a 1:1 ratio to either the intervention or the control group by the use of a computer-generated randomization list managed by an independent project administrator. Blocking, the size of the blocks undisclosed, is applied in order to ensure the balanced allocation at several time points in the trial.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Maximum gait speed
timeFrame: 12 weeks
Secondary outcomes:
measure: Foot muscles' morphology derived from ultrasound imaging
timeFrame: 12 weeks
measure: Lower extremity biomechanics during gait assessed with 3D motion and ground reaction force capturing
timeFrame: 12 weeks
measure: Spatiotemporal gait parameters assessed with 3D motion and ground reaction force capturing
timeFrame: 12 weeks
measure: Balance during gait assessed with 3D motion and ground reaction force capturing
timeFrame: 12 weeks
measure: Self-reported mobility limitations
timeFrame: 12 weeks
measure: Weekly time spent in physical activities
timeFrame: 12 weeks
measure: Fall incidents during the intervention
timeFrame: 12 weeks
measure: Fear of falling assessed by the (Falls Efficacy Scale-International) FES-I questionnaire
timeFrame: 12 weeks
measure: Foot plantar pressure during gait assessed by a 2-meter pressure plate
timeFrame: 12 weeks
measure: Static balance assessed by a force plate during single leg stance
timeFrame: 12 weeks
measure: Isometric toe flexor strength assessed by a pressure plate during maximal toe press
timeFrame: 12 weeks
measure: Physical functioning assessed by the Short Physical Performance Battery (SPPB)
timeFrame: 12 weeks
measure: Foot arch characteristics assessed by a 3D foot scanner
timeFrame: 12 weeks
measure: Health related quality of life assessed by SF-36
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Fontys Hogeschool
Study officials:
References: