Clinical trial NCT05852821: The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?
Official title: The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Disease
Lead sponsor: Korian
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the variation in time of 5STS between first assay and fifth assay during the first visit (V1).
timeFrame: 1 day
Secondary outcomes:
measure: the variation in time of 5STS between each trial at the first visit (V1).
timeFrame: 1 day
measure: the variation in time of 5STS between the first visit (V1) and the second visit (V2).
timeFrame: 2 days
measure: the variation in time of 5STS between the second visit (V2) and the third visit (V3).
timeFrame: 1 month
measure: The reproducibility of the remote test
timeFrame: 1 month
measure: The number of tests not carried out
timeFrame: through study completion, an average of 1 year
measure: Patient satisfaction
timeFrame: 1 month
measure: The number of connection failures
timeFrame: through study completion, an average of 1 year
measure: The number of patients excluded because of the video-conference tool
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du Souffle la Vallonie
Study officials:
affiliation: Director of research
name: Nelly HERAUD
role: STUDY_DIRECTOR
References: