Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility (PRP-Pied-AUT)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Healthy Ageing

Treatments: Other: Progressive training program; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05703945

21CH246

ANSM (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Training group

Experimental group

Description:

Participants benefit from an 8-week training program of muscle strengthening

Treatment:

Other: Progressive training program

Control group

Sham Comparator group

Description:

Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study.

Treatment:

Other: Control group