Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

NCT ID: NCT06042751

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-07-31

Brief Summary

Post-Covid(PoC)-patients with fatigue symptoms respond very differently to physical rehabilitation programs. While PoC-patients with psychological symptoms benefit little from physical interventions, fatigue and exercise capacity improves significantly without the presence of psychological symptoms. RCT studies on effects of psychotherapy or the combination of phsical activity with psychotherapy in PoC are not yet available. Therefore, the aim is to investigate the unimodal effects of psychotherapy and exercise therapy or the combination of both on fatigue in PoC patients with fatigue in a randomized clinical trial. Patients will be assigned to the three intervention groups (psychotherapy, physical rehabilitation, combination of both) stratified for sex, gender and BMI status.

The intervention duration is 3 months with therapeutic online sessions for 50 min every 2 weeks. After another 3 months without intervention, the sustainability will evaluated. Secondarily, the investigators analyzes which patient benefits most from which therapeutic approach and seek for specific predictors of patient´s individual response.

Conditions

Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Therapy

Six online consultations focusing on exercise therapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months.

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: BEHAVIORAL

Six online consultations will take place on the basis of the sports medicine assessment every two weeks, resulting in 300 min in 3 months. For the home-based implementation, participants receive wearables with which the activity and training data are collected. In conjunction with feedback, the goal is to ensure that the interventions lead to improvements in self-control, reduced resilience, and fatigue without overwhelming participants with volume or intensity. Due to the expected large differences in personal performance, determined in the initial assessment, the exercise plan is individually designed and regularly adjusted. This includes control of everyday activity as well as moderate endurance and strengthening exercises totalling up to 30min daily. The individual training intensity is below the aerobic lactate threshold so that overload is avoided. The average training heart rate is planned to be in the range between 50 and 70% of the maximum heart rate.

Psychotherapy

Six online consultations focusing on psychotherapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Six online consultations will take place based on the psychosocial assessment and the initial psychosomatic interview every two weeks, resulting in 300 min in 3 months. A structured, telemedicine-supported, modularized, brief psychosomatic intervention is planned with a focus on psychoeducational elements, promotion of self-management, improvement of illness acceptance, modification of self-monitoring, and learning to cope with altered performance levels. The six modularized telemedical sessions taking into account the specific deficits identified in the psychosomatic evaluation. Within the sessions, starting points are identified with the patients, which the patients can work on independently between the sessions.

Combined exercise and psychotherapy

Both interventions (exercise and psychotherapy) are combined. Six biweekly online session with 50% exercise therapy (a 25 min) and 50% psychotherapy (a 25 min) will take place, resulting in 300 min overall therapy in 3 months. The content of the procedure is simultaneous to the interventions described in the exercise therapy arm and the psychotherapy arm, respectively.

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: BEHAVIORAL

Six online consultations will take place on the basis of the sports medicine assessment every two weeks, resulting in 300 min in 3 months. For the home-based implementation, participants receive wearables with which the activity and training data are collected. In conjunction with feedback, the goal is to ensure that the interventions lead to improvements in self-control, reduced resilience, and fatigue without overwhelming participants with volume or intensity. Due to the expected large differences in personal performance, determined in the initial assessment, the exercise plan is individually designed and regularly adjusted. This includes control of everyday activity as well as moderate endurance and strengthening exercises totalling up to 30min daily. The individual training intensity is below the aerobic lactate threshold so that overload is avoided. The average training heart rate is planned to be in the range between 50 and 70% of the maximum heart rate.

Psychotherapy

Intervention Type: BEHAVIORAL

Six online consultations will take place based on the psychosocial assessment and the initial psychosomatic interview every two weeks, resulting in 300 min in 3 months. A structured, telemedicine-supported, modularized, brief psychosomatic intervention is planned with a focus on psychoeducational elements, promotion of self-management, improvement of illness acceptance, modification of self-monitoring, and learning to cope with altered performance levels. The six modularized telemedical sessions taking into account the specific deficits identified in the psychosomatic evaluation. Within the sessions, starting points are identified with the patients, which the patients can work on independently between the sessions.

Interventions

Exercise Therapy

Six online consultations will take place on the basis of the sports medicine assessment every two weeks, resulting in 300 min in 3 months. For the home-based implementation, participants receive wearables with which the activity and training data are collected. In conjunction with feedback, the goal is to ensure that the interventions lead to improvements in self-control, reduced resilience, and fatigue without overwhelming participants with volume or intensity. Due to the expected large differences in personal performance, determined in the initial assessment, the exercise plan is individually designed and regularly adjusted. This includes control of everyday activity as well as moderate endurance and strengthening exercises totalling up to 30min daily. The individual training intensity is below the aerobic lactate threshold so that overload is avoided. The average training heart rate is planned to be in the range between 50 and 70% of the maximum heart rate.

Intervention Type: BEHAVIORAL

Psychotherapy

Six online consultations will take place based on the psychosocial assessment and the initial psychosomatic interview every two weeks, resulting in 300 min in 3 months. A structured, telemedicine-supported, modularized, brief psychosomatic intervention is planned with a focus on psychoeducational elements, promotion of self-management, improvement of illness acceptance, modification of self-monitoring, and learning to cope with altered performance levels. The six modularized telemedical sessions taking into account the specific deficits identified in the psychosomatic evaluation. Within the sessions, starting points are identified with the patients, which the patients can work on independently between the sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients aged over 18 and
• diagnosed post-Covid-19 syndrome: (positive PCR or antibody test) and Fatigue Assessment Scale (FAS) ≥ 22 points

Exclusion Criteria

• Current participation in another intervention study
• Illnesses or functional disorders that potentially explain the fatigue symptoms otherwise
• Any illness or impairment that the examining physician judges to preclude participation in a physical training intervention
• Suicidality or severe mental illness (e.g. mania, acute phase of schizophrenia) that requires acute treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Insurance Audi BKK

UNKNOWN

Sponsor Role: collaborator

occupational health service Volkswagen AG

UNKNOWN

Sponsor Role: collaborator

Helmholtz Centre for Infection Research

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Tegtbur

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School, Institute for Sports Medicine

Locations

Hannover Medical School

Hanover, Lower Saxony, Germany

Countries

Germany

References

Beyer S, Nohre M, Pink I, Hackl S, Thomas NH, Klawonn F, Tegtbur U, de Zwaan M, Haufe S. Comparison of telemedicine-assisted psychotherapy, exercise therapy, or a combination of both in patients with post-COVID-19 syndrome (TelPoCo): study protocol for a randomized controlled trial. Trials. 2025 Jul 20;26(1):251. doi: 10.1186/s13063-025-08968-7.

Reference Type: DERIVED

PMID: 40685367 (View on PubMed)

Other Identifiers

9LZF23

Identifier Type: -

Identifier Source: org_study_id