The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2023
CompletedFirst Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2024
CompletedJanuary 9, 2024
January 1, 2024
9 months
April 27, 2023
January 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
the variation in time of 5STS between first assay and fifth assay during the first visit (V1).
1 day
Secondary Outcomes (8)
the variation in time of 5STS between each trial at the first visit (V1).
1 day
the variation in time of 5STS between the first visit (V1) and the second visit (V2).
2 days
the variation in time of 5STS between the second visit (V2) and the third visit (V3).
1 month
The reproducibility of the remote test
1 month
The number of tests not carried out
through study completion, an average of 1 year
- +3 more secondary outcomes
Study Arms (1)
remote 5STS through videoconference
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korianlead
Study Sites (1)
Clinique du Souffle la Vallonie
Lodève, 34700, France
Study Officials
- STUDY DIRECTOR
Nelly HERAUD
Director of research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 10, 2023
Study Start
April 18, 2023
Primary Completion
January 4, 2024
Study Completion
January 4, 2024
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share