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

Primary Purpose

Chronic Respiratory Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
5STS remote assessment via videoconference
Sponsored by
Korian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique du Souffle la VallonieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

remote 5STS through videoconference

Arm Description

Outcomes

Primary Outcome Measures

the variation in time of 5STS between first assay and fifth assay during the first visit (V1).

Secondary Outcome Measures

the variation in time of 5STS between each trial at the first visit (V1).
the variation in time of 5STS between the first visit (V1) and the second visit (V2).
the variation in time of 5STS between the second visit (V2) and the third visit (V3).
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).
The number of tests not carried out
Patient satisfaction
Satisfaction will be assessed with a questionnaire at the end of visit 3.
The number of connection failures
The number of patients excluded because of the video-conference tool

Full Information

First Posted
April 27, 2023
Last Updated
May 9, 2023
Sponsor
Korian
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1. Study Identification

Unique Protocol Identification Number
NCT05852821
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
February 17, 2024 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remote 5STS through videoconference
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
5STS remote assessment via videoconference
Intervention Description
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).
Primary Outcome Measure Information:
Title
the variation in time of 5STS between first assay and fifth assay during the first visit (V1).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
the variation in time of 5STS between each trial at the first visit (V1).
Time Frame
1 day
Title
the variation in time of 5STS between the first visit (V1) and the second visit (V2).
Time Frame
2 days
Title
the variation in time of 5STS between the second visit (V2) and the third visit (V3).
Time Frame
1 month
Title
The reproducibility of the remote test
Description
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).
Time Frame
1 month
Title
The number of tests not carried out
Time Frame
through study completion, an average of 1 year
Title
Patient satisfaction
Description
Satisfaction will be assessed with a questionnaire at the end of visit 3.
Time Frame
1 month
Title
The number of connection failures
Time Frame
through study completion, an average of 1 year
Title
The number of patients excluded because of the video-conference tool
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly HERAUD, PhD
Phone
+334 67 88 84 91
Email
nelly.heraud@korian.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly HERAUD
Organizational Affiliation
Director of research
Official's Role
Study Director
Facility Information:
Facility Name
Clinique du Souffle la Vallonie
City
Lodève
ZIP/Postal Code
34700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelly HERAUD, PhD
Phone
+33467888491
Email
nelly.heraud@korian.fr
First Name & Middle Initial & Last Name & Degree
Nicolas OLIVER, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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