NCT05703945

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2022-09-06
• Primary completion: 2022-12-09
• Completion: 2023-01-19
• First posted: 2023-01-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: France