Telerehabilitation - Technical Validity and Clinical Feasibility

NCT05314686 | Completed

• 1 other identifier: TelerehApp-Valid/Feasib
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Telerehabilitation; Exercise

Outcome Measures

Primary Outcomes (6)

• Technical validity of the data transmitted remotely - pulse oximeter - concordance between datasets.

  Comparison of paired datasets between the data recorded locally within the internal memory of the pulse oximeter and those collected from the telerehabilitation system.

  Data will be recorded immediately after the intervention.

• Technical validity of the data transmitted remotely - physical activity tracker - concordance between datasets.

  Comparison of paired dataset between the daily data, either automatically collected from the telerehabilitation system or self-reported by the participant (visually displayed on the physical activity tracker).

  Data will be recorded immediately after the intervention.

• Technical validity of the data transmitted remotely - pulse oximeter - proportion of sessions transmitted.

  The number of exercise sessions retrieved from the telerehabilitation system will be expressed in relation to the number of sessions performed.

  Data will be recorded immediately after the intervention.

• Technical validity of the data transmitted remotely - physical activity tracker - proportion of sessions transmitted.

  The number of days with physical activity data retrieved from the telerehabilitation system will be expressed in relation to the number of days that the tracker has been worn by the participant.

  Data will be recorded immediately after the intervention.

• Technical validity of the data transmitted remotely - pulse oximeter - proportion of common usable data.

  The proportion of data without artefacts will be compared between datasets. Artefacts will be identified for heart rate when values indicate two hundred fifty beats per minute and for transcutaneous oxygen saturation when values indicate hundred percent.

  Data will be recorded immediately after the intervention.

• Technical validity of the data transmitted remotely - pulse oximeter - number of session required to be autonomous when using the system.

  Participants will be taught to use the system and they will be requested to set data collection autonomously during the four next sessions. They will be considered autonomous when they will be able to set data collection autonomously without error. The number of sessions (after the first session) required to reach autonomy will be collected.

  Data will be recorded immediately after the intervention.

Secondary Outcomes (21)

• Endurance exercise capacity - constant workload exercise testing.

  Baseline and immediately after the intervention.

• Endurance exercise capacity - six-minute walking test.

  Baseline and immediately after the intervention.

• Endurance exercise capacity - six-minute stepper test.

  Baseline and immediately after the intervention.

• Maximal voluntary isometric quadriceps force.

  Baseline and immediately after the intervention.

• Self-reported quality of life.

  Baseline and immediately after the intervention.

Study Arms (2)

Technical validity of data transmitted remotely.

The first twenty participants will participate in the step of the study aimed at assessing the technical validity of data transmitted remotely from devices connected to the telerehabilitation system.

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

Clinical feasibility.

The last twenty participants will perform their pulmonary rehabilitation program at home using the telerehabilitation system over an eight-week period.

Other: Telerehabilitation

Interventions

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

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.

Technical validity of data transmitted remotely.

Telerehabilitation OTHER

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".

Clinical feasibility.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic obstructive pulmonary disease

You may qualify if:

• Age superior to eighteen years.
• Stable (\> four weeks) chronic obstructive pulmonary disease, GOLD stage II to IV
• Referred to pulmonary rehabilitation (no contraindication to exercise training on a cycle ergometer).
• With or without oxygen during exercise.
• Able to perform forty-five minutes of exercise training on a cycle ergometer.
• Person of legal age who may be present during home exercise sessions (relatives).
• Pregnancy or likely to be.
• Guardianship.
• Unable to consent.
• Referred to pulmonary rehabilitation before lung cancer surgery.
• Referred to pulmonary rehabilitation before lung volume reduction surgery scheduled in the next few months.

You may not qualify if:

• Consent withdrawal

Sponsors & Collaborators

• ADIR Association: lead
• Union des Kinésithérapeutes Respiratoires: collaborator
• CogSci: collaborator
• KerNel Biomedical: collaborator
• Groupe Havrais d'Aide aux Handicapés Respiratoires: collaborator

Study Sites (1)

ADIR Association

Bois-Guillaume, ADIR Association, 76230, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Tristan Bonnevie, PT, PhD

  ADIR Association, Rouen University, Rouen, France

  PRINCIPAL INVESTIGATOR

• Antoine Cuvelier, MD, Prof

  CHU-Hôpitaux de Rouen, Rouen, France.

  STUDY CHAIR

• Jean-François Muir, MD, Prof

  ADIR Association, Rouen, France.

  STUDY CHAIR

• Francis-Edouard Gravier, PT, PhD

  ADIR Association, Rouen, France.

  STUDY CHAIR

• Aurélie Vallée, PhD

  CogSci, Rouen, France.

  STUDY CHAIR

• Michelle Leclerc, PT, MSc

  Union des Kinésithérapeutes Respiratoires, Rouen, France.

  STUDY CHAIR

• Zoe McKeough, PT, Prof

  Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 6, 2022
• Study Start: November 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: August 28, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)