Official Title
Randomized Comparison of a Telemedicine-supported Psychosomatic Intervention, a Physical Activity Intervention and the Combination of Both in Patients with Post-covid19 Syndrom.
Brief Summary

Post-Covid(PoC)-patients with fatigue symptoms respond very differently to physicalrehabilitation programs. While PoC-patients with psychological symptoms benefit littlefrom physical interventions, fatigue and exercise capacity improves significantly withoutthe presence of psychological symptoms. RCT studies on effects of psychotherapy or thecombination of phsical activity with psychotherapy in PoC are not yet available.Therefore, the aim is to investigate the unimodal effects of psychotherapy and exercisetherapy or the combination of both on fatigue in PoC patients with fatigue in arandomized clinical trial. Patients will be assigned to the three intervention groups(psychotherapy, physical rehabilitation, combination of both) stratified for sex, genderand BMI status.The intervention duration is 3 months with therapeutic online sessions for 50 min every 2weeks. After another 3 months without intervention, the sustainability will evaluated.Secondarily, the investigators analyzes which patient benefits most from whichtherapeutic approach and seek for specific predictors of patient´s individual response.

Detailed Description

Not Provided

Recruiting
Post-COVID-19 Syndrome

Behavioral: 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.

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

Hannover Medical School
Hannover, Lower Saxony, Germany

Investigator: Sebastian Beyer, MSc.
Contact: +49 (0) 511 532 5499
beyer.sebastian@mh-hannover.de

Contacts

Sebastian Beyer
+49511532 - 81635
beyer.sebastian@mh-hannover.de

Uwe Tegtbur, Principal Investigator
Hannover Medical School, Institute for Sports Medicine

Hannover Medical School
NCT Number
Keywords
Physical actvity
Psychotherapy
Cobined exercise and psychotherapy
Covid-19
Post-Covid-19-Syndrom
MeSH Terms
COVID-19