Sensors for HEalth Recording and Physical Activity Monitoring (SHERPAM)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Device: sensors

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Unité de Biologie et médecine du Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; Sensors assigned for 3 weeks	Device: sensors; 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.
Experimental: Patients with arythmic disease or peripheral vascular disease; Sensors assigned for 3 weeks	Device: sensors; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
asses the continuous acquisition of data by sensors	transmission and reception of physiological parameters of a patient	every day (during 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test acceptability of SHERPAM Device	questionnary	after 7 days of use
Test acceptability of Sherpam Device	questionnary	after 21 days of use
Test usability of Sherpam Device	questionnary	after 7 days of use
Test usability of Sherpam Device	questionnary	after 21 days of use

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: LTSI-INSERM U1099; CIC-IT 14-14
• Investigators: Principal Investigator: Carre François, MD, Rennes University

Publications and helpful links

General Publications

• Houssein A, Ge D, Gastinger S, Dumond R, Prioux J. Estimation of respiratory variables from thoracoabdominal breathing distance: a review of different techniques and calibration methods. Physiol Meas. 2019 Apr 3;40(3):03TR01. doi: 10.1088/1361-6579/ab0b63.
• Dumond R, Gastinger S, Rahman HA, Le Faucheur A, Quinton P, Kang H, Prioux J. Estimation of respiratory volume from thoracoabdominal breathing distances: comparison of two models of machine learning. Eur J Appl Physiol. 2017 Aug;117(8):1533-1555. doi: 10.1007/s00421-017-3630-0. Epub 2017 Jun 13.
• Khreis S, Ge D, Rahman HA, Carrault G. Breathing Rate Estimation Using Kalman Smoother With Electrocardiogram and Photoplethysmogram. IEEE Trans Biomed Eng. 2020 Mar;67(3):893-904. doi: 10.1109/TBME.2019.2923448. Epub 2019 Jun 17.

Helpful Links

• Princeps article

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Sensors; Health Recording
• Other Study ID Numbers: 35RC17_8836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No