The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?

The purpose of this clinical study is to determine if a learning effect exists when the 5STS is assessed remotely via videoconference in patients with COPD.

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Disease
• Intervention / Treatment: Other: 5STS remote assessment via videoconference

Detailed Description

Pulmonary rehabilitation (PR) is an essential therapy for improving exercise tolerance and quality of life in patients with chronic respiratory disease. It is now available remotely thanks to advances in information and communication technologies. Pulmonary telerehabilitation facilitates care access for patients living far from specialized centers. It requires, for a complete and coherent transposition, to be able to evaluate the patients remotely in order to measure the evolution of their functional capacities and to ensure their follow-up. Among the tests already implemented at home and remotely via video-conference, the 5-repetition sit-to-stand test (5STS) is the most suitable. This test requires only a short time to perform, little space and no specific equipment. However, two major limits remain to be checked before being able to consider its remote and routine implementation. First of all, it is important to study its feasibility. Moreover, like other functional tests, it raises the question of a possible learning effect (LE). In the perspective of a current use of the 5STS remotely, it is therefore also essential to assess the existence of a potential LE which would condition the methods of administering the test and its interpretation.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nelly HERAUD, PhD; Phone Number: +334 67 88 84 91; Email: nelly.heraud@korian.fr

Study Locations

• France
  • Lodève, France, 34700
    • Clinique du Souffle la Vallonie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Obtaining oral informed consent after a minimum reflection period of 24 hours
• Patient with internet access at home and a tool allowing the realization of a videoconference (smartphone or computer)

Exclusion Criteria:

• Patients who had a recent exacerbation (less than 4 weeks)
• Patients physically unable to get up from a chair and sit down without help
• Patients with significant and unstable cardiovascular disease
• Any acute or chronic pathology (orthopedic, neurological, psychiatric or causing a major cognitive disorder) limiting the performance of a functional test
• Inability or difficulty using digital tools
• Subjects in a period of relative exclusion compared to another protocol
• Adults protected by law or patient under guardianship or curatorship
• Subjects deprived of liberty by a judicial or administrative decision
• Current or planned pregnancy during the study period
• Pregnant or breastfeeding women
• Patients not affiliated to a French social security scheme or not benefiting from such a scheme

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remote 5STS through videoconference	Other: 5STS remote assessment via videoconference; Patients will be asked to perform several times the 5STS test, from their home through videoconference, on 3 occasions (day 1, 24h later and 1month later).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the variation in time of 5STS between first assay and fifth assay during the first visit (V1).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the variation in time of 5STS between each trial at the first visit (V1).		1 day
the variation in time of 5STS between the first visit (V1) and the second visit (V2).		2 days
the variation in time of 5STS between the second visit (V2) and the third visit (V3).		1 month
The reproducibility of the remote test	Reproducibility is objectified by the test-retest reliability between two trials of the same series (first and fifth trials of V1) and between two series (V1-V2; V2-V3; V1 -V3).	1 month
The number of tests not carried out		through study completion, an average of 1 year
Patient satisfaction	Satisfaction will be assessed with a questionnaire at the end of visit 3.	1 month
The number of connection failures		through study completion, an average of 1 year
The number of patients excluded because of the video-conference tool		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Korian
• Investigators: Study Director: Nelly Heraud, Director of research

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: e-EVAL

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