Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom (TELPOCO)

Hannover Medical School (MHH)

Status: Active, not recruiting

Conditions: Post-COVID-19 Syndrome

Treatments: Behavioral: Psychotherapy; Behavioral: Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06042751

9LZF23

Details and patient eligibility

About

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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 3 patient groups

Exercise Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Exercise Therapy

Psychotherapy

Experimental group

Description:

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

Treatment:

Behavioral: Psychotherapy

Combined exercise and psychotherapy

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Therapy

Behavioral: Psychotherapy