Telerehabilitation - Technical Validity and Clinical Feasibility

Summary

This prospective study will be held in two steps.

The aim of the first step is to assess the technical validity of transmitting data remotely from different devices connected to a telerehabilitation system. These will include real-time oximetry data during exercise on a cycle ergometer (heart rate and transcutaneous oxygen saturation) as well as daily step count from a commercially available physical activity tracker.

The aim of the second step of the study is to assess the clinical feasibility of using the telerehabilitation system in real life conditions (in the home environment). Briefly, participants will benefit from a eight weeks pulmonary rehabilitation program performed at home, using the telerehabilitation system. Further details about the content of the program and the outcomes are provided below.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

OTHER

Five exercise sessions of forty-five minutes within the pulmonary rehabilitation centre and ten days of using a physical activity tracker.

1. Five exercise sessions of forty-five minutes within the centre on a cycle ergometer using a pulse oximetry device connected to the telerehabilitation system through Bluetooth. Data recorded in the internal memory of the pulse oximeter will be compared with those transmitted through the telerehabilitation system. 2. Ten days of use of a physical activity tracker connected to the telerehabilitation system. Self-reported daily step count by the participants (using a standardized data sheet) will be compared with the daily step count transmitted through the telerehabilitation system.

OTHER

Telerehabilitation

An eight-week program including: * Endurance training on a cycle ergometer (performed independently with remote monitoring or through video conference, according to the participant's preference), three times per week. Training prescription is progressively adjusted using an automated algorithm (aimed to first increase the training duration and then workload intensity). * Peripheral muscle strengthening using the app (the patient will be requested to reproduce different exercises after watching a video) or through video conference, three times per week (thirty minutes). * Daily walking with automated coaching. * Self management education (one to nine sessions according to each individual needs, scheduled through videoconference). * A self evaluation of symptoms through daily or weekly questionnaires. Different types of alert will be triggered at the center according to remote monitoring: "non-adherence", "clinical issue" during endurance exercise sessions and change in "symptoms".

Sponsors & Collaborators

• Union des Kinésithérapeutes Respiratoires

  collaborator UNKNOWN

• CogSci

  collaborator UNKNOWN

• KerNel Biomedical

  collaborator INDUSTRY

• Groupe Havrais d'Aide aux Handicapés Respiratoires

  collaborator UNKNOWN

• ADIR Association

  lead OTHER

Principal Investigators

• Tristan Bonnevie, PT, PhD · ADIR Association, Rouen University, Rouen, France

• Antoine Cuvelier, MD, Prof · CHU-Hôpitaux de Rouen, Rouen, France.

• Jean-François Muir, MD, Prof · ADIR Association, Rouen, France.

• Francis-Edouard Gravier, PT, PhD · ADIR Association, Rouen, France.

• Aurélie Vallée, PhD · CogSci, Rouen, France.

• Michelle Leclerc, PT, MSc · Union des Kinésithérapeutes Respiratoires, Rouen, France.

• Zoe McKeough, PT, Prof · Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-15

Primary Completion

2025-07-31

Completion

2025-08-28

Countries

• France

Study Locations