Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

NCT06042751 | Active Not Recruiting

• 1 other identifier: 9LZF23
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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

Keywords

Physical actvity; Psychotherapy; Cobined exercise and psychotherapy; Covid-19; Post-Covid-19-Syndrom

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Measured with the Fatigue Assessment Scale (FAS). The FAS is a 10-question assessement scale with five questions related to physical fatigue and 5 questions (questions 3 and 6-9) related to mental fatigue. The total score ranges from 10 to 50. A total FAS score \< 22 indicates no fatigue, a score ≥ 22 indicates fatigue, and a score \> 35 indicates extreme fatigue.

  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 (8)

• Health-related quality of life

  The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).

• Depression and Anxiety

  The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).

• Physical and psychological fatigue severity

  The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).

• Post-exertional malaise

  The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).

• Multidimensional Fatigue Inventory

  The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).

Study Arms (3)

Exercise Therapy

EXPERIMENTAL

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

Behavioral: Exercise Therapy

Psychotherapy

EXPERIMENTAL

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

Behavioral: Psychotherapy

Combined exercise and psychotherapy

EXPERIMENTAL

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.

Behavioral: Exercise Therapy; Behavioral: Psychotherapy

Interventions

Psychotherapy 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; Psychotherapy

Exercise Therapy 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.

Combined exercise and psychotherapy; Exercise Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• occupational health service Volkswagen AG: collaborator
• Helmholtz Centre for Infection Research: collaborator
• Hannover Medical School: lead
• Health Insurance Audi BKK: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• 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.

  PMID: 40685367 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Exercise Therapy; Psychotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Behavioral Disciplines and Activities

Study Officials

• Uwe Tegtbur

  Hannover Medical School, Institute for Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: January 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

DE (1)