Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial

COVID-19 Clinical Trial

— RELOAD  

Official title:

Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05172206
• Other study ID #: RELOAD
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:

• Differentiation of rehabilitation effects from natural recovery after COVID-19.

• Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID

• Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.

Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)

Exclusion Criteria:

• no walking ability

• not able to operate smartphone apps

• rehabilitation program within the previous 6 months

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• symptom-focused rehabilitation
Patients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster.
• usual care
Patients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase.

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg
Germany	Praxis Dr. Schrag	Bad Reichenhall
Germany	Pneumologen Lichterfelde Berlin	Berlin
Germany	Praxis im Zentrum Erlangen	Erlangen
Germany	Pneumopraxis Marburg	Marburg
Germany	Lungenärzte am Rundfunkplatz, München	Munich
Germany	COVID ambulance Prof. Koczulla	Schönau am Königssee
Germany	Praxis Dr. Roch	Schwabach

Sponsors (11)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land	Bavarian State Office for Health and Food Safety, COVID ambulance Philipps-University Marburg, COVID ambulance Pneumology LMU Munich, COVID ambulance psychology LMU Munich, COVID ambulance Schön Klinik Schönau, Pneumologen Lichterfelde Berlin, Pneumologie Elisenhof Munich, Pneumopraxis Marburg, Praxis im Zentrum Erlangen, University Clinic Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12	the scale of the physical and mental Health component summary score ranges from minimum 0 to maximum 100 points with higher scores indicating better quality of life	baseline, week 4, week 12
Secondary	Change from baseline COVID-related symptoms at week 4 and week 12	the number of COVID-symptoms will recorded as well as their intensity will be rated on a scale from 0 [not relevant] until 10 [very severe symptom].	baseline, week 4, week 12
Secondary	Change from baseline lung function at week 4 and week 12	following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide	baseline, week 4, week 12
Secondary	Change from baseline blood gas analysis at week 4 and week 12	following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide	baseline, week 4, week 12
Secondary	Change from baseline Cardiac Doppler echocardiography at week 4 and week 12	Left and right heart echocardiography will be performed	baseline, week 4, week 12
Secondary	Change from baseline laboratory parameters at week 4 and week 12	blood samples will be taken from venous blood	baseline, week 4, week 12
Secondary	Change from baseline exercise performance at week 4 and week 12	incremental cardiopulmonary exercise testing will be performed with spirometry	baseline, week 4, week 12
Secondary	Change from baseline health care service needs at week 4 and week 12	Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded	baseline, week 4, week 12
Secondary	Change from baseline working capability at week 4 and week 12	number of days of incapacity to work until the last visit will be recorded	baseline, week 4, week 12
Secondary	Change from baseline sleep quality at week 4 and week 12	Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21 with higher scores indicating higher impairment)	baseline, week 4, week 12
Secondary	Change from baseline sleep quality at week 4 and week 12	daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)	baseline, week 4, week 12
Secondary	Change from baseline Depression status assessed by Patient Health Questionnaire 9	the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms	baseline, week 4, week 12
Secondary	Change from baseline Depression status assessed by Generalized Anxiety Disorder Scale 7	the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms	baseline, week 4, week 12
Secondary	Change from baseline resilience assessed by resilience scale 13	the total score ranges from 13 to 91 points with higher scores indicating higher resilience	baseline, week 4, week 12
Secondary	Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test	the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status	baseline, week 4, week 12
Secondary	Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12	the total score ranges from 0 to 4 points with higher scores indicating more dyspnea	baseline, week 4, week 12
Secondary	Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12	the total score ranges from 0 to 64 points with higher scores indicating hyperventilation	baseline, week 4, week 12
Secondary	Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12	the total score ranges from 10 to 50 points with higher scores indicating more fatigue	baseline, week 4, week 12
Secondary	Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12	the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis	baseline, week 12
Secondary	Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12	the total score ranges from 0 to 4 points with higher scores indicating more impairment	baseline, week 4, week 12
Secondary	Change from baseline physical activity assessed by Garmin watch at week 4 and week 12	daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App	baseline, week 4, week 12
Secondary	Change from baseline blood pressure assessed at week 4 and week 12	blood pressure will be measured at the upper arm using the Aponorm device	baseline, week 4, week 12
Secondary	Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12	Beurer pulse oximeter	baseline, week 4, week 12
Secondary	Change from baseline peak flow assessed by peak flow meter at week 4 and week 12	peak flow will be assessed by smart one spirometer	baseline, week 4, week 12