Energy Level Diary for Patients With Post-COVID Syndrome

NCT06883500 | Completed

• 1 other identifier: PCS_EnergyDiary
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

Post-COVID-19 Syndrome (PCS) is characterized by symptoms, including fatigue, reduced physical performance, dyspnea, cognitive impairment, and psychological distress. Pateints have difficulties with energy management and often feel drained even after simple motor or cognitive tasks, which often leads to so called Crashes, after which patients are often bedridden for several day. This study examined wether an energy diary would facilitate the process of pacing during rehabilitation and beyond.

Conditions

Post COVID Syndrome; Chronic Fatigue Symptoms

Keywords

post-covid syndrom; chronic fatigue syndrome; energy diary; rehabilitation

Outcome Measures

Primary Outcomes (1)

• energy level according to energy diary

  In an initial step, a diary was developed by experts together with patients (co-design). Versions of the diary were then provided to patients to investigate usability as well as sensitivity to daily changes in fatigue/ energy levels. Patient interviews were performed to collect feedback. The final version of the diary was validated against the Multidimensional Fatigue Inventory-20 (MFI-20). Patients completed the diary during inpatient (Koenigsfeld) and outpatient (Cologne) medical rehabilitation both including a combination of physical, cognitive and respiratory training as well as relaxation- and psychotherapy as indicated.

  2 years

Study Arms (1)

Patients in neurological and cardiological rehablitation with Post-Covid Syndrome

A co-design approach was used and the diary was developed over three phases through repeated feedback loops including interviews with patients with PCS and an expert consensus, consisting of doctors, scientists, and therapists, using the Delphi method.

Behavioral: Energy diary

Interventions

Energy diary BEHAVIORAL

A prospective observational study is conducted at two German rehabilitation centers in a co-design approach with repeated feedback loops (expert consensus, patient interviews). Daily energy-changes will be analyzed and validated using the Multidimensional Fatigue Inventory-20 (MFI-20).

Also known as: MFI-20

Patients in neurological and cardiological rehablitation with Post-Covid Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with PCS referred for medical rehabilitation at Clinic Koenigsfeld Ennepetal, Germany and Neurological Therapy Center Cologne, Germany

You may qualify if:

• history of (at least one) COVID-19 infection (positive PCR test at the time of infection), and ongoing or newly expressed performance deficits lasting for at least 3 months prior to recruitment.

You may not qualify if:

• age below 18

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (2)

Neurologic Therapy Center Cologne

Cologne, North Rhine-Westphalia, 50668, Germany

Location

Clinic Königsfeld,

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location

Related Publications (1)

• Balke M, Garbsch R, Cormann J, Pape P, Mooren FC, Schmitz B. Design and validation of an energy level diary for fatigue management in patients with post-COVID syndrome. Front Rehabil Sci. 2025 Jul 21;6:1633466. doi: 10.3389/fresc.2025.1633466. eCollection 2025.

  PMID: 40761505 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 19, 2025
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: September 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

DE (2)