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

Completed

• Conditions: Post-COVID-19
• Interventions: Behavioral: Multimodal pulmonary rehabilitation

• Registration Number: NCT05496842
• Lead Sponsor: Pensionsversicherungsanstalt

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-01-31
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 779

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rehabilitation patients with post-COVID-19 Syndrome	Multimodal pulmonary rehabilitation	This group includes rehabilitation patients with and without respiratory muscle training

Primary Outcome Measures

Name	Time	Method
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)	3 weeks of inpatient rehabilitation	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.
6-minute walk test	3 weeks of inpatient rehabilitation	The 6-minute walk test is a standardized tool to assess functional exercise capacity operationalized by the walk distance.
Patient Health Questionnaire-4 (PHQ-4)	3 weeks of inpatient rehabilitation	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.

Trial Locations

Locations (1)

Rehabilitationszentrum Weyer; 🇦🇹 Weyer, Upper Austria, Austria