Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation

NCT05496842 | Completed

• 1 other identifier: 0009 Post-COVID
• Study Type: observational
• Target: 779
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength). The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).

Conditions

Post-COVID-19

Outcome Measures

Primary Outcomes (3)

• 6-minute walk test

  The 6-minute walk test is a standardized tool to assess functional exercise capacity operationalized by the walk distance.

  3 weeks of inpatient rehabilitation

• European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)

  The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions. Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health.

  3 weeks of inpatient rehabilitation

• Patient Health Questionnaire-4 (PHQ-4)

  The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.

  3 weeks of inpatient rehabilitation

Study Arms (1)

Rehabilitation patients with post-COVID-19 Syndrome

This group includes rehabilitation patients with and without respiratory muscle training

Behavioral: Multimodal pulmonary rehabilitation

Interventions

Multimodal pulmonary rehabilitation BEHAVIORAL

The rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.

Rehabilitation patients with post-COVID-19 Syndrome

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Regular patients with post-COVID-19 Syndrome in inpatient rehabilitation.

You may qualify if:

• The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.

Sponsors & Collaborators

• Pensionsversicherungsanstalt: lead

Study Sites (1)

Rehabilitationszentrum Weyer

Weyer, Upper Austria, 3335, Austria

Location

Study Officials

• David Felder, Mag.

  Pensionsversicherungsanstalt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: October 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: February 28, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)