Clinical trial NCT06042751: Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: Physical actvity
Psychotherapy
Cobined exercise and psychotherapy
Covid-19
Post-Covid-19-Syndrom
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Health Insurance Audi BKK
name: occupational health service Volkswagen AG
name: Helmholtz Centre for Infection Research
First posted: 2023-09-21
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One study arm will receive exercise therapy with 6 treatments over three months.

One study arm receives psychotherapy with 6 treatments over three months. One study arm receives combined exercise and psychotherapy over three months.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fatigue
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary outcomes:
measure: Health-related quality of life
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Depression and Anxiety
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Physical and psychological fatigue severity
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Post-exertional malaise
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Multidimensional Fatigue Inventory
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Disability
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Work ability
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
measure: Illness Perception
timeFrame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School, Institute for Sports Medicine
name: Uwe Tegtbur
role: PRINCIPAL_INVESTIGATOR
References: