NCT06016192

Brief Summary

Post-COVID-19 syndrome (PCS) occurs as a sequelae after acute infection with the SARS-CoV-2 virus (COVID-19 infection). PCS is defined as symptom persistence over a period of 12 weeks from infection and/or the appearance of new symptoms in this period. While the majority of affected patients experience a gradual healing process without targeted treatment, the need for effective medical rehabilitation is high at least for patients with persistent PCS. Given that physical exercise has been shown to be beneficial in multiple pathologies such as cardiovascular diseases, neuropathic disorders, and pulmonary diseases it has been suggested that physical exercise including aerobic training could exert beneficial effects also in PCS. This study aims to analyse the use of moderate-intensity aerobic exercise training for medical rehabilitation of PCS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

August 28, 2023

Last Update Submit

August 29, 2023

Conditions

Post-COVID-19 SyndromeLong-COVID-19 Syndrome

Keywords

COVID-19FatigueRehabilitationExercise TrainingInfectious Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Cardiorespiratory Fitness (CRF)

    CRF will be measured as peak oxygen uptake (VO2peak) determined by spiroergometry

    Baseline and week 4 (i. e. before discharge)

Secondary Outcomes (6)

  • Change in Submaximal Cardiorespiratory Fitness (CRF)

    Baseline and week 4 (i. e. before discharge)

  • Change in Fatigue

    Baseline and week 4 (i. e. before discharge)

  • Work requirements and workload

    Baseline

  • Change Health-related quality of life

    Baseline and week 4 (i. e. before discharge)

  • Wellbeing

    Baseline and week 4 (i. e. before discharge)

  • +1 more secondary outcomes

Other Outcomes (5)

  • Change in training load

    Daily, from baseline to week 4 (i. e. before discharge)

  • Training participation

    Daily, from baseline to week 4 (i. e. before discharge)

  • Change in minute ventilation (VE)

    Baseline and week 4 (i. e. before discharge)

  • +2 more other outcomes

Study Arms (2)

Continuous aerobic training

ACTIVE COMPARATOR

Moderate continous endurance training, ergometer

Behavioral: Aerobic Exercise Training

Interval aerobic training

EXPERIMENTAL

Moderate intensity interval training, ergometer

Behavioral: Aerobic Exercise Training

Interventions

Aerobic Exercise TrainingBEHAVIORAL

Physical activity performed as controlled aerobic exercise training on ergometer

Continuous aerobic trainingInterval aerobic training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a history of (at least one) Covid-19 infection
  • ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment
  • referral to inpatient rehabilitation
  • signed informed consent

You may not qualify if:

  • unstable condition
  • incapable of understanding study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic Königsfeld

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCOVID-19FatigueCommunicable Diseases

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

August 29, 2023

Study Start

August 1, 2021

Primary Completion

November 30, 2022

Study Completion

May 31, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

DE(1)