Clinical trial NCT05703945: Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility
Official title: Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Ageing
Keywords: top flexion
individual variability
intrinsic muscle
resistance training
healthy ageing
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: maximum isometric muscle force of flexion of the metatarsophalangeal (MTP) joints
timeFrame: Baseline to Week 18
Secondary outcomes:
measure: Change from Baseline to Week 18 in development of joint flexion strength
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Deformation of the foot
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Foot posture
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Morphology of the foot muscles
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Static postural balance
timeFrame: Baseline to Week 18
measure: Change from Baseline to Month 4 in Force production of the foot complex
timeFrame: Baseline to Month 4
measure: Change from Baseline to Week 18 in the time taken during the "Time Up and Go Test"
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in the distance covered in the "6-minute walk test" (in meters)
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Fall Efficacy Scale (FES-Fr)
timeFrame: Baseline to Week 18
measure: Change from Baseline to Week 18 in Modified Falls Efficacy Scale (MFES-Fr)
timeFrame: Baseline to Week 18
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Pascal EDOUARD, PhD
role: PRINCIPAL_INVESTIGATOR
References: