Sensors for HEalth Recording and Physical Activity Monitoring

NCT ID: NCT03673189

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-28
• Study Completion Date: 2019-09-12

Brief Summary

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.

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.

Conditions

Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Sensors assigned for 3 weeks

Group Type: EXPERIMENTAL

sensors

Intervention Type: 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.

Patients with arythmic disease or peripheral vascular disease

Sensors assigned for 3 weeks

Group Type: EXPERIMENTAL

sensors

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LTSI-INSERM U1099

UNKNOWN

Sponsor Role: collaborator

CIC-IT 14-14

UNKNOWN

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carre François, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University

Locations

Unité de Biologie et médecine du Sport

Rennes, Brittany Region, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 30818285 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28612121 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31217092 (View on PubMed)

Other Identifiers

35RC17_8836

Identifier Type: -

Identifier Source: org_study_id