Fall RiskSTIFF3NCT05531136
Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults
A study testing Foot strengthening training in people with Fall Risk, run by Lydia Willemse at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Risk
- What is being tested?
- Foot strengthening training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2022to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- The respondent is a minor or legally incompetent adult;
- Self-reported presence of any disorder interfering with the execution of the exercises.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Foot strengthening training
- Keywords
- falling, foot exercises, older adults, mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot strengthening trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Foot strengthening training | Experimental | 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. Receives: Other: Foot strengthening training |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum gait speed
The post-intervention difference between the intervention and control group in maximum gait speed.
Measured: 12 weeks
Secondary outcomes (14)
Foot muscles' morphology derived from ultrasound imaging
Measured: 12 weeks
Lower extremity biomechanics during gait assessed with 3D motion and ground reaction force capturing
Measured: 12 weeks
Spatiotemporal gait parameters assessed with 3D motion and ground reaction force capturing
Measured: 12 weeks
Balance during gait assessed with 3D motion and ground reaction force capturing
Measured: 12 weeks
Self-reported mobility limitations
Measured: 12 weeks
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
Measured: 12 weeks
Fall incidents during the intervention
Measured: 12 weeks
Fear of falling assessed by the (Falls Efficacy Scale-International) FES-I questionnaire
Measured: 12 weeks
Foot plantar pressure during gait assessed by a 2-meter pressure plate
Measured: 12 weeks
Static balance assessed by a force plate during single leg stance
Measured: 12 weeks
Isometric toe flexor strength assessed by a pressure plate during maximal toe press
Measured: 12 weeks
Physical functioning assessed by the Short Physical Performance Battery (SPPB)
Measured: 12 weeks
Foot arch characteristics assessed by a 3D foot scanner
Measured: 12 weeks
Health related quality of life assessed by SF-36
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start8 Nov 2022
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Why it stopped: Reaching end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fall RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lydia Willemse
- Sponsor type
- University, hospital or other
- Collaborators
- Fontys University of Applied Sciences, KU Leuven, Tilburg University
- Responsible party
- Sponsor-investigator, Lydia Willemse, Fontys University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531136
- Sponsor's protocol ID
- STIFF 3
- Acronym
- STIFF3
- Status last verified
- Jun 2025
- First submitted
- 26 Jul 2022
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Re-use of the data will be on request and on condition that all Principle Investigators agree and provided the requirements of the ethical committee are met
Publications
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.
PubMed 39033125
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Foot Muscle Strengthening Program in Mobile Older Adults Adults
- ClinicalTrials.gov ID
- NCT05531136
- Acronym / sponsor ID
- STIFF3 / STIFF 3
- Conditions
- Fall Risk
- Keywords
- falling, foot exercises, older adults, mobility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reaching end of funding
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lydia WillemseUniversity, hospital or other
- Collaborators
- Fontys University of Applied Sciences, KU Leuven, Tilburg University
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Foot strengthening training | Experimental | Other: Foot strengthening training12-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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- The respondent is a minor or legally incompetent adult;
- Self-reported presence of any disorder interfering with the execution of the exercises.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot strengthening traininga 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 | Other | Foot strengthening training |
Primary outcome
Maximum gait speed
Time frame: 12 weeks
The post-intervention difference between the intervention and control group in maximum gait speed.
14 secondary outcomes
Foot muscles' morphology derived from ultrasound imaging
Time frame: 12 weeks
Lower extremity biomechanics during gait assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Spatiotemporal gait parameters assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Balance during gait assessed with 3D motion and ground reaction force capturing
Time frame: 12 weeks
Self-reported mobility limitations
Time frame: 12 weeks
Weekly time spent in physical activities
Time frame: 12 weeks
Fall incidents during the intervention
Time frame: 12 weeks
Fear of falling assessed by the (Falls Efficacy Scale-International) FES-I questionnaire
Time frame: 12 weeks
Foot plantar pressure during gait assessed by a 2-meter pressure plate
Time frame: 12 weeks
Static balance assessed by a force plate during single leg stance
Time frame: 12 weeks
Isometric toe flexor strength assessed by a pressure plate during maximal toe press
Time frame: 12 weeks
Physical functioning assessed by the Short Physical Performance Battery (SPPB)
Time frame: 12 weeks
Foot arch characteristics assessed by a 3D foot scanner
Time frame: 12 weeks
Health related quality of life assessed by SF-36
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Reaching end of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 39033125Willemse 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.
- Individual participant dataSharing planned: Undecided. Re-use of the data will be on request and on condition that all Principle Investigators agree and provided the requirements of the ethical committee are met
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot strengthening training in people with Fall Risk, run by Lydia Willemse at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Reaching end of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum gait speed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.