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Sensors for HEalth Recording and Physical Activity Monitoring (SHERPAM)

R

Rennes University Hospital

Status

Completed

Conditions

Physical Activity

Treatments

Device: sensors

Study type

Interventional

Funder types

Other

Identifiers

NCT03673189
35RC17_8836

Details and patient eligibility

About

The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.

Full description

To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in a real life physical activity practice (subjects in their living environment and during their usual physical practices) using the DS's real-time communication tools, automatic data processing, and the DS's ability to produce information.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy volunteers Healthy active subjects aged 50 or over (ie without diagnosed disease, without chronic treatment) and recruited in the sports associations of Ille et Vilaine (cycle tourism clubs).

    • having benefited from an oral or written prescription of physical activity carried out by a health professional and applying this prescription daily in autonomy or in a sports club.

Common to all subjects

  • physically active (adherent to a club or sports association or practicing independently according to the recommendations of their physician);
  • practicing at least once a week;
  • residence located less than 100 km return from Rennes University Hospital
  • affiliate or beneficiary of a social protection scheme;
  • having given his written consent

Exclusion criteria

Common to all subjects

  • wearing a pacemaker or implanted cardiac defibrillator (precaution because using telemetry);
  • participation in another research protocol;
  • persons aver 18 yrs-old subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
  • pregnant or nursing woman.

Trial design

Primary purpose

Device Feasibility

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Healthy volunteers
Experimental group
Description:
Sensors assigned for 3 weeks
Treatment:
Device: sensors
Patients with arythmic disease or peripheral vascular disease
Experimental group
Description:
Sensors assigned for 3 weeks
Treatment:
Device: sensors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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