Post-COVID-19 SyndromeTELPOCONCT06042751
Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom
A study testing Exercise Therapy and Psychotherapy in people with Post-COVID-19 Syndrome, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Exercise Therapy and Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 27 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 and
- diagnosed post-Covid-19 syndrome: (positive PCR or antibody test) and Fatigue Assessment Scale (FAS) ≥ 22 points
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Exercise Therapy, Psychotherapy
- Keywords
- Physical actvity, Psychotherapy, Cobined exercise and psychotherapy, Covid-19, Post-Covid-19-Syndrom
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyBehavioural
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.
PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy | Experimental | Six online consultations focusing on exercise therapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months. Receives: 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. Receives: 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. Receives: Behavioral: Exercise Therapy; Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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 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.
Measured: 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 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
Measured: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
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).
Measured: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
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.
Measured: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
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)
Measured: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2024
- Primary completion10 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Health Insurance Audi BKK, occupational health service Volkswagen AG, Helmholtz Centre for Infection Research
- Responsible party
- Sponsor
- Investigators
- Uwe Tegtbur, Principal investigator, Hannover Medical School, Institute for Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042751
- Sponsor's protocol ID
- 9LZF23
- Acronym
- TELPOCO
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40685367
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06042751
- Acronym / sponsor ID
- TELPOCO / 9LZF23
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- Physical actvity, Psychotherapy, Cobined exercise and psychotherapy, Covid-19, Post-Covid-19-Syndrom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Health Insurance Audi BKK, occupational health service Volkswagen AG, Helmholtz Centre for Infection Research
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy | Experimental | Behavioral: Exercise TherapySix online consultations focusing on exercise therapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months. |
| Psychotherapy | Experimental | Behavioral: PsychotherapySix online consultations focusing on psychotherapy, each lasting 50 minutes every two weeks, resulting in 300 min in 3 months. |
| Combined exercise and psychotherapy | Experimental | Behavioral: Exercise Therapy, Behavioral: PsychotherapyBoth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 18 and
- diagnosed post-Covid-19 syndrome: (positive PCR or antibody test) and Fatigue Assessment Scale (FAS) ≥ 22 points
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapySix 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. | Behavioural | Combined exercise and psychotherapy, Exercise Therapy |
| PsychotherapySix 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. | Behavioural | Combined exercise and psychotherapy, Psychotherapy |
Primary outcome
Fatigue
Time frame: 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 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.
8 secondary outcomes
Health-related quality of life
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Disability
Time frame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Work ability
Time frame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Illness Perception
Time frame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 40685367Beyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Tegtbur principal investigator
Hannover Medical School, Institute for Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy and Psychotherapy in people with Post-COVID-19 Syndrome, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: The questionnaire will be completed at baseline, after the intervention (after 3 months), and after another 3-month observation period (after 6 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.