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

Sponsor
Korian (Other)
Overall Status
Recruiting
CT.gov ID
NCT05852821
Collaborator
(none)
40
1
1
12
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 5STS remote assessment via videoconference
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?
Actual Study Start Date :
Apr 18, 2023
Anticipated Primary Completion Date :
Feb 17, 2024
Anticipated Study Completion Date :
Apr 17, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. the variation in time of 5STS between first assay and fifth assay during the first visit (V1). [1 day]

Secondary Outcome Measures

  1. the variation in time of 5STS between each trial at the first visit (V1). [1 day]

  2. the variation in time of 5STS between the first visit (V1) and the second visit (V2). [2 days]

  3. the variation in time of 5STS between the second visit (V2) and the third visit (V3). [1 month]

  4. The reproducibility of the remote test [1 month]

    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).

  5. The number of tests not carried out [through study completion, an average of 1 year]

  6. Patient satisfaction [1 month]

    Satisfaction will be assessed with a questionnaire at the end of visit 3.

  7. The number of connection failures [through study completion, an average of 1 year]

  8. The number of patients excluded because of the video-conference tool [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique du Souffle la Vallonie Lodève France 34700

Sponsors and Collaborators

  • Korian

Investigators

  • Study Director: Nelly HERAUD, Director of research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korian
ClinicalTrials.gov Identifier:
NCT05852821
Other Study ID Numbers:
  • e-EVAL
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023