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

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ClinicalTrials.gov Identifier: NCT03280875
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Other: pedalling exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Personalisation of Exercise by Muscle Modulation, Step 1: Construction and Validation of an Algorithm for Personalisation for Pedalling Exercises
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: healthy volunteers Other: pedalling exercises
pedalling exercises on a bicycle ergometer




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280875


Contacts
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Contact: Jean-Marie CASILLAS, MD 3 80 29 38 15 ext +33 jean-marie.casillas@chu-dijon.fr

Locations
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France
CHU dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Jean-Marie Casillas, MD    3 80 29 38 15 ext +33    jean-marie.casillas@chu-dijon.fr   
Contact: Davy LAROCHE    3 80 29 56 65 ext +33    davy.laroche@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03280875     History of Changes
Other Study ID Numbers: Casillas ANR 2015
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No