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OpenTrials
Completed

NCT Number: NCT05852821

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Souffle la Vallonie

Lodève, 34700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5STS remote assessment via videoconference

Other

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 outcomes

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

    Time frame: 1 day

Secondary outcomes

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

    Time frame: 1 day

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

    Time frame: 2 days

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

    Time frame: 1 month

  4. The reproducibility of the remote test

    Time frame: 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

    Time frame: through study completion, an average of 1 year

  6. Patient satisfaction

    Time frame: 1 month

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

  7. The number of connection failures

    Time frame: through study completion, an average of 1 year

  8. The number of patients excluded because of the video-conference tool

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Korian

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2023
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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