Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:10 PM
Study NCT ID:
NCT05172206
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2021-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change from baseline COVID-related symptoms at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': '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\\].'}, {'measure': 'Change from baseline lung function at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide'}, {'measure': 'Change from baseline blood gas analysis at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide'}, {'measure': 'Change from baseline Cardiac Doppler echocardiography at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'Left and right heart echocardiography will be performed'}, {'measure': 'Change from baseline laboratory parameters at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'blood samples will be taken from venous blood'}, {'measure': 'Change from baseline exercise performance at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'incremental cardiopulmonary exercise testing will be performed with spirometry'}, {'measure': 'Change from baseline health care service needs at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded'}, {'measure': 'Change from baseline working capability at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'number of days of incapacity to work until the last visit will be recorded'}, {'measure': 'Change from baseline sleep quality at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': '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)'}, {'measure': 'Change from baseline sleep quality at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)'}, {'measure': 'Change from baseline Depression status assessed by Patient Health Questionnaire 9', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms'}, {'measure': 'Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms'}, {'measure': 'Change from baseline resilience assessed by resilience scale 13', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 13 to 91 points with higher scores indicating higher resilience'}, {'measure': 'Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status'}, {'measure': 'Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 4 points with higher scores indicating more dyspnea'}, {'measure': 'Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 64 points with higher scores indicating hyperventilation'}, {'measure': 'Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 10 to 50 points with higher scores indicating more fatigue'}, {'measure': 'Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12', 'timeFrame': 'baseline, week 12', 'description': 'the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis'}, {'measure': 'Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'the total score ranges from 0 to 4 points with higher scores indicating more impairment'}, {'measure': 'Change from baseline physical activity assessed by Garmin watch at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App'}, {'measure': 'Change from baseline blood pressure assessed at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'blood pressure will be measured at the upper arm using the Aponorm device'}, {'measure': 'Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'Beurer pulse oximeter'}, {'measure': 'Change from baseline peak flow assessed by peak flow meter at week 4 and week 12', 'timeFrame': 'baseline, week 4, week 12', 'description': 'peak flow will be assessed by smart one spirometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'intervention', 'quality of life', 'long-COVID', 'post-COVID syndrome', 'sequelae', 'recovery'], 'conditions': ['COVID-19', 'Long-COVID']}, 'descriptionModule': {'briefSummary': '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:\n\n* Differentiation of rehabilitation effects from natural recovery after COVID-19.\n* Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID\n* Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)\n\nExclusion Criteria:\n\n* no walking ability\n* not able to operate smartphone apps\n* rehabilitation program within the previous 6 months'}, 'identificationModule': {'nctId': 'NCT05172206', 'acronym': 'RELOAD', 'briefTitle': 'Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Schön Klinik Berchtesgadener Land'}, 'officialTitle': 'Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RELOAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Symptom-focused Rehabilitation', 'description': "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.", 'interventionNames': ['Other: symptom-focused rehabilitation']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': '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.', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'symptom-focused rehabilitation', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Symptom-focused Rehabilitation']}, {'name': 'usual care', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'country': 'Germany', 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bad Reichenhall', 'country': 'Germany', 'facility': 'Praxis Dr. Schrag', 'geoPoint': {'lat': 47.72947, 'lon': 12.87819}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Pneumologen Lichterfelde Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Praxis im Zentrum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Pneumopraxis Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Lungenärzte am Rundfunkplatz, München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Schönau am Königssee', 'country': 'Germany', 'facility': 'COVID ambulance Prof. Koczulla', 'geoPoint': {'lat': 47.60055, 'lon': 12.98704}}, {'city': 'Schwabach', 'country': 'Germany', 'facility': 'Praxis Dr. Roch', 'geoPoint': {'lat': 49.33047, 'lon': 11.02346}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schön Klinik Berchtesgadener Land', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bavarian State Office for Health and Food Safety', 'class': 'UNKNOWN'}, {'name': 'Praxis im Zentrum Erlangen', 'class': 'UNKNOWN'}, {'name': 'Pneumologen Lichterfelde Berlin', 'class': 'UNKNOWN'}, {'name': 'Pneumopraxis Marburg', 'class': 'UNKNOWN'}, {'name': 'COVID ambulance Philipps-University Marburg', 'class': 'UNKNOWN'}, {'name': 'Pneumologie Elisenhof Munich', 'class': 'UNKNOWN'}, {'name': 'COVID ambulance Pneumology LMU Munich', 'class': 'UNKNOWN'}, {'name': 'COVID ambulance psychology LMU Munich', 'class': 'UNKNOWN'}, {'name': 'University Clinic Augsburg', 'class': 'UNKNOWN'}, {'name': 'COVID ambulance Schön Klinik Schönau', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Dr. Andreas Rembert Koczulla', 'investigatorAffiliation': 'Schön Klinik Berchtesgadener Land'}}}}