COFONIPsyAkt: Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

Sponsor

Hannover Medical School (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06042751

Collaborator

Health Insurance Audi BKK (Other), occupational health service Volkswagen AG (Other), Helmholtz Centre for Infection Research (Other)

195

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID-19 Syndrome	Behavioral: Exercise Therapy Behavioral: Psychotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Sep 29, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Therapy Six online consultations focusing on exercise therapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months.	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.
Experimental: Psychotherapy Six online consultations focusing on psychotherapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months.	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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: Exercise Therapy

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

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.

Experimental: Psychotherapy

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

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.

Experimental: 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.

Behavioral: Exercise Therapy

Behavioral: Psychotherapy

Outcome Measures

Primary Outcome Measures

Fatigue [The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).]
Measured with the Fatigue Assessment Scale (FAS). The FAS is a 10-question questionnaire designed to assess fatigue. Five questions relate to physical fatigue and 5 questions (questions 3 and 6-9) relate to mental fatigue. Each question must be answered even if the person has no symptoms at the moment. The results of questions 4 and 10 are scored inversely (1=5, 2=4, 3=3, 4=2, 5=1). Then, the total FAS score can be calculated by adding the scores of all questions (recoded scores for questions 4 and 10). 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. A total score as well as a psychological and physical score are given.

Secondary Outcome Measures

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).]
Measured with the Short Form-36 (SF-36) questionnaire. The 36 questions of the SF-36 are designed to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social functioning, emotional role, and mental health (range 0-100). In addition, a physical (PCS) and mental (MCS) composite score can be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
Clinically relevant acute or chronic infections
Organ damage caused by Covid19, which requires prior clarification
Any illness or impairment that the examining physician judges to preclude participation in a physical training intervention.