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Completed

NCT Number: NCT03673189

Sensors for HEalth Recording and Physical Activity Monitoring

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité de Biologie et médecine du Sport

Rennes, Brittany Region, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

sensors

Device

Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.

Primary outcomes

  1. asses the continuous acquisition of data by sensors

    Time frame: every day (during 3 weeks)

    transmission and reception of physiological parameters of a patient

Secondary outcomes

  1. Test acceptability of SHERPAM Device

    Time frame: after 7 days of use

    questionnary

  2. Test acceptability of Sherpam Device

    Time frame: after 21 days of use

    questionnary

  3. Test usability of Sherpam Device

    Time frame: after 7 days of use

    questionnary

  4. Test usability of Sherpam Device

    Time frame: after 21 days of use

    questionnary

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • CIC-IT 14-14
  • LTSI-INSERM U1099

Registry information

Acronym: SHERPAM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
May 24, 2023

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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