Healthy AgeingPRP-Pied-AUTNCT05703945
Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility
A study testing Progressive training program in people with Healthy Ageing, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This randomized controlled trial aims to explore the effect of a toe flexion resistance training protocol on toe flexion strength and morphology, as well as in older adults (65-85 completed years) mobility related construct. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Progressive training program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to 19 Jan 2023
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 60 and 85 completed years;
- To be male or female;
- To be in good health meaning to be in a complete state of physical, mental and social well-being with the absence of pathologies, pain or complaints to the lower limbs,
- Be affiliated or beneficiary of a social security insurance;
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
Who cannot join
- Use of pharmacological therapy to match gander identity; Have a major comorbidity corresponding to a score >4 points on the Charlson Comorbidity Index (French Version);
- Score <24 points in the MMSE-Fr;
- Have spasticity or severe cerebellar ataxia in the leg;
- Have an abnormal range of motion of the toes and/or ankle;
- Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
- Have a musculoskeletal injury that impairs walking or balance;
Show all 11Show fewer
- Have a high resting heart rate (> 90 beats per minute) and blood pressure > 144/94 mmHg;
- Have a history of illness or conditions that would compromise the safety of the participant during the study;
- Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
- Being unable to understand the purpose and conditions of the study, and to give consent;
- Being deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial aims to explore the effect of a toe flexion resistance training protocol on toe flexion strength and morphology, as well as in older adults (65-85 completed years) mobility related construct. The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up.
Read the detailed description
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a training intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
- Conditions
- Healthy Ageing
- Being tested
- Progressive training program, Control group
- Keywords
- top flexion, individual variability, intrinsic muscle, resistance training, healthy ageing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive training programOther
The intervention consists of progressive training program : toe plantar flexion isometric at 30° of dorsal flexion of the metatarsophalangeal joint (0° is considered the anatomical position). The training will be performed in the same customized device used for the measurement. Each session consists of four sets at 80% of the maximal voluntary contraction performed until task failure. Between the sets, 2 minutes of rest will be allowed. Maximal voluntary contraction estimate will be updated every session of training, testing it before the start. The test is considered part of the training intervention. The total impulse performed during the single session will be recorded. Participants will train twice a week for 8 weeks. Training will be performed with both the feet.
Control groupOther
The control group will not perform the progressive training program after visit 2 and will continue all of their daily activities during the 8-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Participants benefit from an 8-week training program of muscle strengthening Receives: Other: Progressive training program |
| Control group | Sham comparator | Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum isometric muscle force of flexion of the metatarsophalangeal (MTP) joints
the maximum isometric muscle force of joint flexion MTP (in N) measured with an ergometer composed of a 3-dimensional sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol. The measure is defined as the difference between the highest point and the baseline (week 1) in the signal time series.
Measured: Baseline to Week 18
Secondary outcomes (10)
Change from Baseline to Week 18 in development of joint flexion strength
The rate of force development measured by the area under the curve (Impulse - N/s) in the force time series during a specific task. The 0-200ms windows will be considered.
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Deformation of the foot
It's a composite outcome.
To assess foot deformity measurements will be taken:
By measuring in cm: height of the navicular, total length of the foot, truncated length of the foot, width of the midfoot and height of the dorsal arch when the participant is seated and then when standing on one foot thanks to the device By the "Manchester Scale" allowing to classify the severity of the hallux valgus (in arbitrary unit) by means of an observation of the deformity according to 4 levels: no deformity, slight deformity, average deformity and severe deformity
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Foot posture
Foot posture will be measured using the Foot Posture Index (FPI-6). It is a diagnostic tool used to quantify the degree to which a foot is pronated, neutral or supinated.
There are six criteria for the Foot Posture Index for the physical therapist to observe. They include: Talar head palpation, Supra and infra lateral malleoli curvature (viewed from behind), Calcaneal frontal plane position (viewed from behind), Prominence in region of TNJ (viewed at an angle from inside, Congruence of medial longitudinal arch (viewed from inside), Abduction/adduction of forefoot on rearfoot (view from behind). All criteria are graded from -2 to +2.
Features commensurate with an approximately neutral foot posture are graded as zero, while Pronated postures are given a positive value, the higher the value the more pronated.
Supinated features are given a negative value, the more negative the value the more supinated.
For a neutral foot the final FPI aggregate score should lie somewhere around zero
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Morphology of the foot muscles
The morphology of the foot muscles will be evaluated with the AixPlorer Ultrasonic scanner, version 6.1.1; Supersonic Imagine, Aix-en-Provence, France
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Static postural balance
Static postural balance will be evaluated using a force platform (Kistler, Winterhur, Switzerland) during 2 balance tasks: unipodal support with eyes open on the dominant foot and on the non dominant foot.
Measured: Baseline to Week 18
Change from Baseline to Month 4 in Force production of the foot complex
The force production of the foot complex during walking will be evaluated using a 3D analysis system (Motion analysis corporation, Raptor 4, Santa Rosa, CA, USA)
Measured: Baseline to Month 4
Change from Baseline to Week 18 in the time taken during the "Time Up and Go Test"
It will be evaluated using :
the time taken during the "Time Up and Go Test" (in seconds)
Measured: Baseline to Week 18
Change from Baseline to Week 18 in the distance covered in the "6-minute walk test" (in meters)
it will be evaluated using the distance covered in the "6-minute walk test" (in meters)
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Fall Efficacy Scale (FES-Fr)
The Fall Efficacy Scale (FES-Fr) in French version to evaluate the apprehension/fear of falling by the participants.
It is a tool that measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned) Minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)
Measured: Baseline to Week 18
Change from Baseline to Week 18 in Modified Falls Efficacy Scale (MFES-Fr)
The Modified Falls Efficacy Scale (MFES-Fr) to assess self-efficacy in the face of falls.
The MFES includes outdoor activities (transportation, crossing roads and light gardening and hanging out the washing). Each item is scored on the 10-point visual analogue scale: 0 = not confident or not sure at all, 5 = fairly confident or fairly sure, and 10 = completely confident or completely sure. The total score is the average of all the item scores.
Hence, the total score ranges from zero to ten. Higher scores reflect more confidence and less fear of falling while lower scores reflect less confidence and more fear of falling. Participants are classified as either fearful (MFES score < 8) or not fearful (MFES score ≥ 8) based on an earlier proposition
Measured: Baseline to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start6 Sep 2022
- Primary completion9 Dec 2022
- Study completion19 Jan 2023
Why it stopped: The training protocol in place is not sufficiently adapted to older people
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgeingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial with repeated measures, monocentric, in 2 parallel groups of elderly subjects (60-85 years) in good general health: one receiving an 8-week muscle strengthening program (PRP group), the other not (control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal EDOUARD, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703945
- Sponsor's protocol ID
- 21CH246
- Other IDs
- ANSM
- Acronym
- PRP-Pied-AUT
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility
- ClinicalTrials.gov ID
- NCT05703945
- Acronym / sponsor ID
- PRP-Pied-AUT / 21CH246
- Conditions
- Healthy Ageing
- Keywords
- top flexion, individual variability, intrinsic muscle, resistance training, healthy ageing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The training protocol in place is not sufficiently adapted to older people
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 30 Jan 2023 (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.
This randomized controlled trial aims to explore the effect of a toe flexion resistance training protocol on toe flexion strength and morphology, as well as in older adults (65-85 completed years) mobility related construct. The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up.
Detailed description
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a training intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial with repeated measures, monocentric, in 2 parallel groups of elderly subjects (60-85 years) in good general health: one receiving an 8-week muscle strengthening program (PRP group), the other not (control group).
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Progressive training programParticipants benefit from an 8-week training program of muscle strengthening |
| Control group | Sham comparator | Other: Control groupParticipants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 60 and 85 completed years;
- To be male or female;
- To be in good health meaning to be in a complete state of physical, mental and social well-being with the absence of pathologies, pain or complaints to the lower limbs,
- Be affiliated or beneficiary of a social security insurance;
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
Key exclusion criteria (11 listed)
- Use of pharmacological therapy to match gander identity; Have a major comorbidity corresponding to a score >4 points on the Charlson Comorbidity Index (French Version);
- Score <24 points in the MMSE-Fr;
- Have spasticity or severe cerebellar ataxia in the leg;
- Have an abnormal range of motion of the toes and/or ankle;
- Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
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 |
|---|---|---|
| Progressive training programThe intervention consists of progressive training program : toe plantar flexion isometric at 30° of dorsal flexion of the metatarsophalangeal joint (0° is considered the anatomical position). The training will be performed in the same customized device used for the measurement. Each session consists of four sets at 80% of the maximal voluntary contraction performed until task failure. Between the sets, 2 minutes of rest will be allowed. Maximal voluntary contraction estimate will be updated every session of training, testing it before the start. The test is considered part of the training intervention. The total impulse performed during the single session will be recorded. Participants will train twice a week for 8 weeks. Training will be performed with both the feet. | Other | Training group |
| Control groupThe control group will not perform the progressive training program after visit 2 and will continue all of their daily activities during the 8-week intervention period. | Other | Control group |
Primary outcome
maximum isometric muscle force of flexion of the metatarsophalangeal (MTP) joints
Time frame: Baseline to Week 18
the maximum isometric muscle force of joint flexion MTP (in N) measured with an ergometer composed of a 3-dimensional sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol. The measure is defined as the difference between the highest point and the baseline (week 1) in the signal time series.
10 secondary outcomes
Change from Baseline to Week 18 in development of joint flexion strength
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Deformation of the foot
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Foot posture
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Morphology of the foot muscles
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Static postural balance
Time frame: Baseline to Week 18
Change from Baseline to Month 4 in Force production of the foot complex
Time frame: Baseline to Month 4
Change from Baseline to Week 18 in the time taken during the "Time Up and Go Test"
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in the distance covered in the "6-minute walk test" (in meters)
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Fall Efficacy Scale (FES-Fr)
Time frame: Baseline to Week 18
Change from Baseline to Week 18 in Modified Falls Efficacy Scale (MFES-Fr)
Time frame: Baseline to Week 18
Results and safety
The study was stopped early (reason given: The training protocol in place is not sufficiently adapted to older people). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Pascal EDOUARD, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive training program in people with Healthy Ageing, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 11 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 19 Sep 2024. 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 France. 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. Some participants in this study may receive a placebo. 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: The training protocol in place is not sufficiently adapted to older people). 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 isometric muscle force of flexion of the metatarsophalangeal (MTP) joints (time frame: Baseline to Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.