Active not recruitingNAINTERVENTIONAL

Psychosomatic, Physical Activity or Both for Post-covid19 Syndrom

This study is investigating new ways to treat people who have ongoing tiredness (fatigue) due to Post-COVID-19 Syndrome. We know that some people with fatigue after COVID-19 might also have psychological symptoms, which can make physical rehabilitation less effective. This research will compare three different approaches: psychotherapy (talking therapy), exercise therapy, or a combination of both. The main goal is to see which of these treatments best helps reduce fatigue. Researchers will also look at whether certain personal factors, like your sex or body weight, influence how well you respond to each treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

195

Start

01 Jan 2024

Estimated completion

31 Jul 2026

Post-COVID-19 Syndrome

What is this study about?

Many people who have had COVID-19 continue to experience various symptoms, a condition often called Post-COVID-19 Syndrome, or 'Long Covid.' One of the most common and difficult symptoms is extreme tiredness, also known as fatigue. This study aims to find the most effective ways to help people struggling with this type of fatigue.

Previous research has shown that not everyone with fatigue after COVID-19 responds the same way to physical activity programs. For example, if someone also has psychological symptoms, physical exercise alone might not be as helpful. However, if there are no significant psychological symptoms, physical activity can really improve tiredness and how well someone can do physical tasks. Currently, there aren't many studies that directly compare talking therapies, physical activity, or a combination of both for Post-COVID-19 fatigue. This study hopes to fill that gap.

By comparing these different approaches, the researchers want to understand which treatment works best for whom. They will also look into why some people respond better to certain treatments. The findings from this study could help doctors and healthcare providers offer more personalised and effective treatments for people suffering from Post-COVID-19 fatigue in the future.

Key takeaways

Targets fatigue in Post-COVID-19 Syndrome.
Compares psychotherapy, exercise, or both.
Aims to find the most effective treatment.
Online sessions for 3 months, then 3 months follow-up.
Looks at why some people respond better to certain treatments.
Participation is voluntary and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with Post-COVID-19 Syndrome. This means you would have had a positive COVID-19 test (either a PCR test or an antibody test). You also need to be experiencing a significant level of fatigue, which will be checked using a special questionnaire called the Fatigue Assessment Scale.

Certain situations would prevent you from taking part. For example, if you are already involved in another research study for Post-COVID-19 syndrome, you wouldn't be able to join this one. Also, if your fatigue could be explained by another illness or medical condition, or if a doctor feels that taking part in a physical exercise program would not be safe for you, then you wouldn't be eligible.

Finally, if you are experiencing severe mental health issues, such as thoughts of harming yourself, or if you have a serious mental illness that requires urgent treatment (like a severe stage of schizophrenia or mania), you would not be able to participate. This is to ensure the safety and well-being of all participants.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Post-COVID-19 Syndrome?
Are you currently experiencing significant fatigue?
Are you not currently in another research study for Post-COVID-19?
Are you generally healthy enough to do some physical activities?
Do you not have severe mental health issues requiring urgent treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of three groups: a group receiving psychotherapy (talking therapy), a group doing physical exercise therapy, or a group receiving a combination of both. The treatments will last for three months. During this time, you will have online therapy sessions for about 50 minutes, every two weeks.

After these three months of treatment, there will be another three-month period where you won't have any specific interventions. The researchers will then check at the end of this period to see how long any improvements have lasted. Throughout the study, there will likely be assessments to monitor your fatigue and overall well-being. The total duration of your active participation, including follow-up, will be around six months.

Potential risks and benefits

Taking part in this study might offer you potential benefits, such as receiving specialised support for your Post-COVID-19 fatigue through either talking therapy, exercise, or a combination. The aim is to help you feel better and improve your quality of life. As with any exercise program, there's a small risk of discomfort or minor injury, and talking therapy can sometimes bring up difficult feelings. The researchers will be closely monitoring your well-being. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hannover Medical School
Verified postcode
Hanover, Germany

Common questions

What is Post-COVID-19 Syndrome?

It's when people have symptoms, like fatigue, that continue for weeks or months after having COVID-19.

Will I have to pay to join this study?

No, you will not have to pay to participate in this research study.

What kind of exercise will I do?

The study mentions 'physical rehabilitation,' which could involve guided exercises aimed at improving your fitness and reducing fatigue. More details would be provided by the study team.

What is psychotherapy?

This is a type of talking therapy that helps you understand and manage your thoughts, feelings, and behaviours.

Can I choose which group I'm in?

No, participants will be randomly assigned to one of the three treatment groups to ensure fair comparison.