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

Chronic Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852821
• Other study ID #: e-EVAL
• Status: Completed
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Korian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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).

Locations

Country	Name	City	State
France	Clinique du Souffle la Vallonie	Lodève

Sponsors (1)

Lead Sponsor	Collaborator
Korian

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the variation in time of 5STS between first assay and fifth assay during the first visit (V1).		1 day
Secondary	the variation in time of 5STS between each trial at the first visit (V1).		1 day
Secondary	the variation in time of 5STS between the first visit (V1) and the second visit (V2).		2 days
Secondary	the variation in time of 5STS between the second visit (V2) and the third visit (V3).		1 month
Secondary	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
Secondary	The number of tests not carried out		through study completion, an average of 1 year
Secondary	Patient satisfaction	Satisfaction will be assessed with a questionnaire at the end of visit 3.	1 month
Secondary	The number of connection failures		through study completion, an average of 1 year
Secondary	The number of patients excluded because of the video-conference tool		through study completion, an average of 1 year