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Completed

NCT Number: NCT03280875

Creation of an Algorithm for the Personalisation of 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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pedalling exercises

Other

pedalling exercises on a bicycle ergometer

Primary outcomes

  1. Preliminary phase: level of perception of effort dissociated from the pain felt

    Time frame: through study phase completion, an average of 3 months

  2. Phase 1:level of pain measured by visual analog scale

    Time frame: through study phase completion, an average of 9 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: EXOMODE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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