To investigate the effect of adding PIFM strengthening exercises to a functional exercise program compared to a functional exercise program alone on maximum gait speed in mobile older adults. The secondary objective is to also investigate the effect…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The post-intervention difference between the intervention and control group in
maximum gait speed.
Secondary outcome
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.
Background summary
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.
Study objective
To investigate the effect of adding PIFM strengthening exercises to a
functional exercise program compared to a functional exercise program 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 RCT, with a 12-week PIFM strengthening
intervention period and pre- and post-intervention laboratory measurements.
Intervention
Both the control and the intervention group continue with the regular
functional exercise program. 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.
Study burden and risks
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.
Dominee Theodor Fliednerstraat 2
Eindhoven 5631 BN
NL
Dominee Theodor Fliednerstraat 2
Eindhoven 5631 BN
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in the study, a respondent must:
- be 65 years of age or over;
- be able to ambulate 10 meter without using a walking aid;
- engage in a functional exercise program (e.g. gymnastics, senior fit
programs) , delivered by an educated or certified physical therapist or trainer
to a group of older adults;
- 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
A respondent who meets the following criteria is excluded from participation in
this study:
- The respondent is a minor or legally incompetent adult;
- Self-reported presence of any disorder interfering with the execution of the
exercises.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05531136 |
| CCMO | NL80110.015.21 |