Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634318
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2020-11-17
Brief Title:
Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae REHABCOVID
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Organization:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study Overview
Official Title:
Organization of Pulmonary Rehabilitation of Post-COVID-19 Patient With Sequelae Assessment and Therapeutic Indication of Tele-rehabilitation Versus Conventional Rehabilitation
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REHABCOVID
Brief Summary:
Some patients with COVID-19 have sequelae after the acute phase of infection These sequelae can be physical dyspnea exercise intolerance abnormal fatigue but also psychic anxiety depression Systemic sequelae have also been observed in pulmonary cardiac hepatic renal nervous or immune systems Respiratory rehabilitation RR is indicated in these patients to help their complete recovery without sequelae These patients arrival and sanitary constraints imposed by COVID-19 changed the organization of Health Care Centers HCC Risk of contagiousness after the acute phase of infection still exists Consequently patients must respect a quarantine time on their arrival in HCC and then have no contact with other HCC patients to respect the barrier rules and social distancing measures HCC accommodation capacities are reduced and this is to the detriment of patients with chronic diseases for whom RR is essential Certain HCCs saturation can also be responsible for a non-proposal of RR in the care pathway of patients after COVID-19 To cope with the new constraints imposed by Covid-19 pandemic telemedicine is being developed in the affected industrial countries Some SRH physicians are starting to offer post-COVID-19 patients the possibility of carrying out a tele-rehabilitation program TRR Such a telemedicine program has been validated for people with respiratory failure It allows the patient to follow his care program without leaving his home and it does not require the visit from a health professional In addition to reducing the inflow of post COVID-19 patients in HCC it allows fragile patients to respect social distancing It could also contain virus spread virus on the territory by reducing patient movements When choosing between RR and TRR the clinician must ask himself two questions Is TRR as efficient as RR for post-COVID-19 patients Is there a profile of patients for whom either method gives better results This study proposes to evaluate both methods a 4-week TRR program vs a conventional RR program in post COVID-19 patients with sequelae If the hypothesis that both methods have similar effects is verified this would allow the generalization of the prescription of TRR The benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients There will also be collective public health benefits by maintaining sufficient access to HCC for patients with chronic diseases
Detailed Description:
Some COVID-19 patients have sequelae after infection acute phase These sequelae can be physical dyspnea exercise intolerance abnormal fatigue but also psychic anxiety depression Systemic sequelae have also been observed in pulmonary cardiac hepatic renal nervous or immune systems Respiratory rehabilitation RR is indicated in these patients to help their complete recovery Regional Health Agencies ARS have listed Health Care Centers HCCs that can welcome these patients Their arrival and sanitary constraints imposed by COVID-19 changed these HCC organization Risk of contagiousness after infection acute phase still exists Consequently patients must first respect a quarantine time and then have no contact with other HCC patients to respect barrier rules HCC accommodation capacities are reduced to the detriment of patients with chronic diseases for whom RR is essential Certain SSRs saturation can also be responsible for a non-proposal of RR to COVID-19 patients To cope with the new constraints imposed by COVID-19 telemedicine is being developed in affected industrial countries Some SRH physicians are starting to offer post-COVID-19 patients a tele-rehabilitation program TRR Such a program has been validated for people with respiratory failure It allows a patient to follow his care program without leaving home and it does not require health professional visits In addition to reducing post COVID-19 patient inflow in HCC it allows fragile patients to respect social distancing and could contain virus spread on the territory by reducing patient movements When choosing between RR and TRR a clinician must ask himself two questions Is TRR as efficient as RR for post-COVID-19 patients Is there a profile of patients for whom either method gives better results This study evaluates both methods a 4-week TRR program vs a conventional RR program If the hypothesis that both methods have similar effects is verified this would allow TRR prescription generalization Benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients There will also be collective benefits by maintaining sufficient SSR access for patients with chronic diseases
This study could also help clinicians to choose the best therapeutic methods to combat post COVID-19 sequelae Indeed effectiveness study of rehabilitation programs according to medical physical and psychological patient profile will define what is the most suitable post COVID-19 care method TRR or RR for each patient Thus it could help to determine the characteristics of the patients for whom a tele-rehabilitation program is indicated
Sessions carried out in RR and TRR programs are similar Session number is the same in both programs They have the same goal and the same intensity In RR program sessions are carried out at Renée Sabran Hospital supervised by medical staff In TRR program sessions are carried out at patients home supervised by medical staff by video-conference Additionally aerobic and walking sessions are carried out outside home The intensity of each session will be controlled by heart rate monitor
The same outcome measurements are carried out before and after both respiratory rehabilitation programs To verify that both respiratory rehabilitation programs have similar efficiency outcome measures will be analyzed using a 2-factor analysis of variance
group TRR vs RR
time before vs after respiratory rehabilitation program
Relationship between effectiveness of both respiratory rehabilitation programs and the different characteristics of patients when programs start will be analyzed using multiple linear regression
This study could also help clinicians to choose the best therapeutic methods to combat post COVID-19 sequelae Indeed effectiveness study of rehabilitation programs according to medical physical and psychological patient profile will define what is the most suitable post COVID-19 care method TRR or RR for each patient Thus it could help to determine the characteristics of the patients for whom a tele-rehabilitation program is indicated
Sessions carried out in RR and TRR programs are similar Session number is the same in both programs They have the same goal and the same intensity In RR program sessions are carried out at Renée Sabran Hospital supervised by medical staff In TRR program sessions are carried out at patients home supervised by medical staff by video-conference Additionally aerobic and walking sessions are carried out outside home The intensity of each session will be controlled by heart rate monitor
The same outcome measurements are carried out before and after both respiratory rehabilitation programs To verify that both respiratory rehabilitation programs have similar efficiency outcome measures will be analyzed using a 2-factor analysis of variance
group TRR vs RR
time before vs after respiratory rehabilitation program
Relationship between effectiveness of both respiratory rehabilitation programs and the different characteristics of patients when programs start will be analyzed using multiple linear regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A02838-31 | OTHER | Id-RCB | None |