TRIBAL-individualized, training-based treatment of Long COVID

TRIBAL-individualized, training-based treatment of Long COVID - TRIBAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039011

Enrollment

Registered

2026-01-21

Start date

2022-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

U09.9

Interventions

Group 1: TRIBAL Study (“Training-Based Individualized Treatment of Long COVID”) is a primary interventional study consisting of an intervention group compared to a wait-list control group, both of whi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis according to ICD-10: U09.9

Exclusion criteria

Exclusion criteria: Severity level 4 (according to Klok et al.)

Design outcomes

Primary

Measure	Time frame
A patient reaches the status of a “Finisher” in the TRIBAL program when specific clinical, physiological, and functional target parameters are stably fulfilled. These parameters mark the successful completion of treatment and the transition to improved everyday functional capacity. The Finisher status is defined by the following values: • Clinical severity: The clinical classification of the disease (according to Klok et al.) must reach a value of = 1. • Physical impairment: The PCS score (Post-COVID Syndrome Score) must decrease to a value below 10. • Fatigue symptoms and quality of life: In the FACIT score, a value of = 42 must be achieved, indicating a clear improvement in fatigue perception and quality of life. • Cell morphology: The morphological deviations of the red blood cells (erythrocytes) must have normalized and show a deviation rate of less than 8% in physiological structure. • Physical performance: The patient must be able to produce a stable output of at least 2 watts per kilogram of body weight (2 W/kg). • Exercise tolerance: A decisive functional criterion is the six-week completion of Phase 5 (High-Intensity Training) without triggering a “crash” (post-exertional malaise, PEM). The procedure is considered technically completed under standard conditions when these parameters are stably confirmed after six weeks in Phase 5.	—

Measure

Time frame

A patient reaches the status of a “Finisher” in the TRIBAL program when specific clinical, physiological, and functional target parameters are stably fulfilled. These parameters mark the successful completion of treatment and the transition to improved everyday functional capacity. The Finisher status is defined by the following values: • Clinical severity: The clinical classification of the disease (according to Klok et al.) must reach a value of = 1. • Physical impairment: The PCS score (Post-COVID Syndrome Score) must decrease to a value below 10. • Fatigue symptoms and quality of life: In the FACIT score, a value of = 42 must be achieved, indicating a clear improvement in fatigue perception and quality of life. • Cell morphology: The morphological deviations of the red blood cells (erythrocytes) must have normalized and show a deviation rate of less than 8% in physiological structure. • Physical performance: The patient must be able to produce a stable output of at least 2 watts per kilogram of body weight (2 W/kg). • Exercise tolerance: A decisive functional criterion is the six-week completion of Phase 5 (High-Intensity Training) without triggering a “crash” (post-exertional malaise, PEM). The procedure is considered technically completed under standard conditions when these parameters are stably confirmed after six weeks in Phase 5.

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Secondary

Measure	Time frame
A key secondary endpoint used in the clinical and scientific accompanying studies of the TRIBAL program (e.g., Kieffer et al., 2024) for the objective assessment of functional capacity is the 1-Minute Sit-to-Stand Test (1MSTST). Below is a detailed description of this and another physiological endpoint: 1. The 1-Minute Sit-to-Stand Test (1MSTST) This test serves as an objective measure of lower-limb muscular endurance and the cardiovascular response to a functional everyday load. • Procedure: The patient is instructed to stand up from and sit down on a chair without armrests (seat height approx. 46–48 cm) as many times as possible within one minute, without using their arms for support. • Collected data: In addition to the total number of repetitions, heart rate, oxygen saturation, and subjective perceived exertion on the Borg scale (0–10) are measured immediately before and after the test. • Clinical relevance: An increase of at least three repetitions over the course of the intervention is considered a clinically meaningful difference (“minimal important difference”). Studies on the TRIBAL program have demonstrated an average improvement of 4 repetitions over 12 weeks. • Correlation: Higher values in the 1MSTST strongly correlate with improved workload (power in watts) on the ergometer, underscoring the validity of the test as an indicator of overall physical performance capacity. 2. The Mechanical Sensitivity Index (MS) In further mechanophysiological sub-investigations (e.g., Grau et al., 2024), the Mechanical Sensitivity Index is used as a specific physiological endpoint to validate the functional deformability of red blood cells (erythrocytes) under stress. • Measurement principle: The MS index indicates how well erythrocytes are able to maintain or adapt their shape under different shear stresses (5, 25, 50, and 75 pascal) and across varying time intervals (1 to 16 seconds). • Relevance in Long COVID: An elevated MS index indicates a reduced	—

Measure

Time frame

A key secondary endpoint used in the clinical and scientific accompanying studies of the TRIBAL program (e.g., Kieffer et al., 2024) for the objective assessment of functional capacity is the 1-Minute Sit-to-Stand Test (1MSTST). Below is a detailed description of this and another physiological endpoint: 1. The 1-Minute Sit-to-Stand Test (1MSTST) This test serves as an objective measure of lower-limb muscular endurance and the cardiovascular response to a functional everyday load. • Procedure: The patient is instructed to stand up from and sit down on a chair without armrests (seat height approx. 46–48 cm) as many times as possible within one minute, without using their arms for support. • Collected data: In addition to the total number of repetitions, heart rate, oxygen saturation, and subjective perceived exertion on the Borg scale (0–10) are measured immediately before and after the test. • Clinical relevance: An increase of at least three repetitions over the course of the intervention is considered a clinically meaningful difference (“minimal important difference”). Studies on the TRIBAL program have demonstrated an average improvement of 4 repetitions over 12 weeks. • Correlation: Higher values in the 1MSTST strongly correlate with improved workload (power in watts) on the ergometer, underscoring the validity of the test as an indicator of overall physical performance capacity. 2. The Mechanical Sensitivity Index (MS) In further mechanophysiological sub-investigations (e.g., Grau et al., 2024), the Mechanical Sensitivity Index is used as a specific physiological endpoint to validate the functional deformability of red blood cells (erythrocytes) under stress. • Measurement principle: The MS index indicates how well erythrocytes are able to maintain or adapt their shape under different shear stresses (5, 25, 50, and 75 pascal) and across varying time intervals (1 to 16 seconds). • Relevance in Long COVID: An elevated MS index indicates a reduced

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Countries

Germany

Contacts

Public ContactBjörn Haiduk

S.P.O.R.T Institut (priv.) GmbH

haiduk@sportinstitut.net+4922045089740

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026