NCT03280875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

4 years

First QC Date

August 4, 2017

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

healthy volunteers

EXPERIMENTAL
Other: pedalling exercises

Interventions

pedalling exercises on a bicycle ergometer

healthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) \[2\].

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU dijon Bourgogne

Dijon, 21079, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2017

First Posted

September 13, 2017

Study Start

May 2, 2017

Primary Completion

April 28, 2021

Study Completion

May 13, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations