Creation of an Algorithm for the Personalisation of Pedalling Exercises (EXOMODE)

Personalisation of Exercise by Muscle Modulation, Step 1: Construction and Validation of an Algorithm for Personalisation for Pedalling Exercises

The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation of Concentric and / or Eccentric training programmes adapted to the individual to improve the efficiency and tolerance. This algorithm will make it possible to personalise trainings programmes according to the different profiles of subjects, determined on the basis of their personal characteristics (age, sex, comorbidities), their exercise capacity and muscle performance, their level of motivation and their perception of the workload, and of the principal objective of the training programme. The final goal is to develop a tool to allow elderly populations to exercise more easily and more effectively.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: pedalling exercises

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject able to understand simple instructions and to provide consent
• Men or women aged 18 to 75 years old.
• Subjects who engage in moderate physical activity (Level 1 or 2 defined by the recommendations for the classification of subjects during performance studies) [2].

Exclusion Criteria:

• Persons without national health insurance cover,
• Cardio-respiratory failure, coronaropathy, severe obstructive cardiomyopathy,
• Recent history of venous thromboembolism (previous 3 months),
• Any medical disorder that could have a major impact on functional capacities (examples: non-stabilised metabolic disorders, such as progressive renal failure, severe asthenia related to a non-stabilised disease, such as neoplasia, systemic disease…),
• Physical disability affecting the lower limbs or the pelvis that could impair or prevent exercise on a cycle ergometer, whether neurological (central or peripheral), arterial (i particular, arteriopathy of the lower limbs with a systolic index < 0.6) or orthopaedic (degenerative or inflammatory rheumatism).
• Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: healthy volunteers	Other: pedalling exercises; pedalling exercises on a bicycle ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preliminary phase: level of perception of effort dissociated from the pain felt	through study phase completion, an average of 3 months
Phase 1:level of pain measured by visual analog scale	through study phase completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2017
• Primary Completion (ACTUAL): April 28, 2021
• Study Completion (ACTUAL): May 13, 2021

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Casillas ANR 2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No