Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility

NCT ID: NCT05703945

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-01-19

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.

Conditions

Healthy Ageing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training group

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

Group Type: EXPERIMENTAL

Progressive training program

Intervention Type: OTHER

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 group

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

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: OTHER

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.

Interventions

Progressive training program

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.

Intervention Type: OTHER

Control group

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal EDOUARD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

21CH246

Identifier Type: -

Identifier Source: org_study_id