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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03280875
Other study ID # Casillas ANR 2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2017
Est. completion date May 13, 2021

Study information

Verified date July 2021
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date May 13, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 diseaseā€¦), - 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 Design


Related Conditions & MeSH terms


Intervention

Other:
pedalling exercises
pedalling exercises on a bicycle ergometer

Locations

Country Name City State
France CHU dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preliminary phase: level of perception of effort dissociated from the pain felt through study phase completion, an average of 3 months
Primary Phase 1:level of pain measured by visual analog scale through study phase completion, an average of 9 months
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