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

NCT05703945 | Terminated

• 2 other identifiers: 21CH246ANSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Ageing

Keywords

top flexion; individual variability; intrinsic muscle; resistance training; healthy ageing

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 18

Secondary Outcomes (10)

• Change from Baseline to Week 18 in development of joint flexion strength

  Baseline to Week 18

• Change from Baseline to Week 18 in Deformation of the foot

  Baseline to Week 18

• Change from Baseline to Week 18 in Foot posture

  Baseline to Week 18

• Change from Baseline to Week 18 in Morphology of the foot muscles

  Baseline to Week 18

• Change from Baseline to Week 18 in Static postural balance

  Baseline to Week 18

Study Arms (2)

Training group

EXPERIMENTAL

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

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.

Other: Control group

Interventions

Progressive training program 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.

Training group

Control group 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.

Control group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pascal EDOUARD, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A centralized randomization will be performed at the 3rd visit so that participants do not know which group they will be assigned to during the control period. Participants do not know which group they will be assigned to during the control period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: January 30, 2023
• Study Start: September 6, 2022
• Primary Completion: December 9, 2022
• Study Completion: January 19, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)