Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

Post-COVID-19 Syndrome Clinical Trial

— TELPOCO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042751
• Other study ID #: 9LZF23
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 29, 2025

Study information

• Verified date: February 2024
• Source: Hannover Medical School
• Contact: Sebastian Beyer
• Phone: +49511532
• Email: beyer.sebastian[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: September 29, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (4)

Lead Sponsor	Collaborator
Hannover Medical School	Health Insurance Audi BKK, Helmholtz Centre for Infection Research, occupational health service Volkswagen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Health-related quality of life	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. The range is 0-100, with higher scores indicating higher quality of life. In addition, a physical (PCS) and mental (MCS) composite score can be calculated.	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary	Depression and Anxiety	Measured with the Hospital Anxiety and Depression Scale (HADS). The HADS questionaire consists of fourteen items pertaining to the two subscales for anxiety and depression. Scores for the anxiety and depression subscale range from 0 to 21, with higher score indicating more severe anxiety or depression. Values can be interpreted as normal from 0-7 points, mild (8-10 points), moderate (11-14 points), and severe (15-21 points).	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary	Physical and psychological fatigue severity	Measured with the Chalder Fatigue Skala (CFS). The 11-part self-report instrument consists of a total scale and two subscales, physical and psychological fatigue. The maximum total score is 33, with higher scores indicating higher levels of fatigue. The maximum score for physical fatigue is 21 (7 items) and for mental fatigue is 12 (4 items). Additionally, a binary code can be calculated for each of the 11 items (0 and 1 = 0; 2 and 3 = 1) to identify cases of severe fatigue. A total score of 4 or more indicates severe 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	Post-exertional malaise	The post-exertional malaise scale (PEM-scale) uses five different 5-point Likert scales to assess the frequency or severity of PEM symptoms and a 7-point Likert scale to assess the duration of PEM evaluate resulting in a maximum score of 46.	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary	Multidimensional Fatigue Inventory	The Multidimensional Fatigue Inventory questionaire (MFI-20) is a 20-item self-assessment instrument consisting of five subscales: (1) general fatigue, (2) physical fatigue, (3) decreased activity, (4) decreased motivation, and (5) mental fatigue. Each subscale consists of four items with response options on a five-point Likert scale (1 = yes, that applies, 5 = no, that does not apply). Higher scores indicate higher levels of 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	Disability	The Bell Disability Scale includes eleven statements about the level of physical function. The scale is rated in increments of 10, from 0 (very severe, constantly bedridden) to 100 (healthy).	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary	Work ability	The work ability index questionnaire (WAI) contains seven questions concerning work, work ability and health, resulting in a total score ranging from seven to 49, with higher values representing greater work ability.	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Secondary	Illness Perception	The Brief Illness Perception Questionnaire (IPQ) assesses cognitive and emotional illness perception. The here used short IPQ contains eight new items as well as part of the causal scale previously used in the IPQ-R. All items except the causal question are rated on a scale of 0 to 10. Five of the items assess cognitive representations of illness: consequences (Item 1), time frame (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items capture emotional representations: concern (item 6) and feelings (item 8). One item assesses the comprehensibility of the illness (Item 7). The causal representation is assessed using an open-response item in which patients are asked to list the three most important causal factors for their illness (Item 9)	The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).