NCT05599906

Brief Summary

The aim of the present study is to answer the question of whether a rehabilitation measure has a positive effect on fatigue symptoms, physical performance, and the physical and psychological well-being of the patients. In particular, the fatigue that occurs in most of all patients is of interest here. In order to make this measurable, the FAS questionnaire plays a special role, which should be completed by all 100 patients upon inclusion in the study and upon discharge from the rehabilitation clinic. In addition, the HADS-D questionnaire (Hospital Anxiety and Depression Scale) for self-assessment of depressive symptoms and anxiety symptoms and the SF-12 questionnaire (Short Form Health Survey) are used as a screening tool to assess health-related quality of life. For the clinical examination of physical performance, the six-minute walk test, a body plethysmography and a long-term ECG are performed on recruited patients on admission and before discharge. In a three-month follow-up, all recruited patients should receive an FAS, HADS-D and SF-12 questionnaire to fill out. Some of these will also be called back to the clinic to check the development of lung function or performance, defined on the basis of VO2max, and will undergo an additional spiroergometric examination. Thus, the effectiveness and effectiveness of the rehabilitation measures in patients under long-COVID is checked.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

October 25, 2022

Last Update Submit

March 28, 2023

Conditions

Keywords

long covid

Outcome Measures

Primary Outcomes (3)

  • Course of fatigue symptoms measured with the FAS score

    Analysis of the questionnaires

    Day one

  • Course of fatigue symptoms measured with the FAS score

    Analysis of the questionnaires

    after 3 weeks

  • Course of fatigue symptoms measured with the FAS score

    Analysis of the questionnaires

    after 3 Months

Interventions

Completion of 3 questionnaires (HADS; SF-12; FAS) at the beginning and end of the rehabilitation and after 3 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient with long/post-covid

You may qualify if:

  • ≥ 18 years, written consent; inpatient stay in the participating rehabilitation clinic

You may not qualify if:

  • lack of consent, Illnesses or functional disorders which, in the opinion of the investigator, exclude participation in this clinical trial (dementia, psychotic disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paracelsus Harzklinik Bad Suderode GmbH

Quedlinburg, 06485, Germany

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 31, 2022

Study Start

October 11, 2021

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

March 29, 2023

Record last verified: 2022-10

Locations