Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

The effects of the manipulation of 5-HT, DA and NA on exercise-induced fatigue and brain activation

This research study is investigating how specific natural chemicals in the brain affect how tired people feel when they exercise. These chemicals include serotonin (5-HT), dopamine (DA), and noradrenaline (NA). The study aims to understand the physical changes in the body, changes in how people behave, and what people report feeling as fatigue sets in and progresses due to these brain chemicals. Researchers will be using medicines like Edronax, Rilatine, and P-Tablets (Lichtenstein) as part of this investigation. The goal is to get a clearer picture of how these brain chemicals influence tiredness during physical activity and how the brain reacts.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Vrije Universiteit Brussel

Enrolment target

Start

29 Aug 2024

None

What is this study about?

This study is designed to explore how some of the natural chemicals in our brain, called neurotransmitters, influence how tired we feel when we exercise. Think of neurotransmitters as messengers that send signals throughout your brain and body. The specific ones being looked at are serotonin, dopamine, and noradrenaline.

The researchers want to understand how changes in these brain chemicals affect three main things when people get tired during physical activity. Firstly, they'll look at physical changes in the body. Secondly, they'll observe any changes in how people behave. And thirdly, they'll ask participants about what they are feeling. By doing this, the study hopes to get a full picture of how these brain chemicals impact tiredness and how our brains react.

To do this, the study will involve using certain medications: Edronax, Rilatine, and P-Tablets (Lichtenstein). These medications are used to adjust the levels of the brain chemicals being studied. This type of research is important because understanding how brain chemicals affect tiredness during exercise could eventually help us find better ways to manage fatigue for many people.

Key takeaways

Researchers are studying brain chemicals (serotonin, dopamine, noradrenaline) and exercise tiredness.
The study aims to understand physical, behavioural, and feeling changes when fatigue sets in.
Specific medications (Edronax, Rilatine, P-Tablets) will be used to adjust brain chemical levels.
It's open to adults aged 18 and over, both men and women, with no specific health conditions mentioned.
Participation will involve regular visits, taking medication, and various assessments.
You can leave the study at any time without it affecting your medical care.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning people of all adult ages can be considered.

This study is open to both men and women. The researchers want to include participants of all sexes to make sure the results are as widely applicable as possible.

There are no specific health conditions mentioned that would prevent you from taking part, meaning the study is not focused on people with particular illnesses. However, there will likely be other health checks and criteria that are not listed here, which a study doctor would discuss with you.

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?
Are you able to participate in physical exercise?
Are you comfortable potentially taking study medications?
Are you able to attend regular appointments at a clinic?

Answer every question to see your result.

What does participation involve?

The information provided does not give detailed steps of what taking part involves. However, based on the study type, you would typically expect to:

* **Have initial screening visits:** This would involve checking your medical history and doing some tests to make sure you are suitable and healthy enough for the study. * **Regular visits to the study clinic:** You would probably need to attend the study site many times. These visits might involve taking the study medications (Edronax, Rilatine, or P-Tablets) and undergoing various tests. * **Assessments:** These might include physical examinations, blood tests, and tests to measure your exercise performance and how tired you feel. You would also likely answer questionnaires about your feelings and experiences. The study mentions looking at brain activation, so there might be brain scans too. * **Taking medication:** You would be given the study medications as instructed by the research team. * **Follow-up:** After the main part of the study, there would likely be follow-up appointments to check on your health and any effects of the medication.

The total duration of the study is not mentioned, but studies often last several weeks or months.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to scientific understanding about tiredness and brain function, which could help others in the future. You would also receive close medical attention and monitoring. However, there are potential risks, including side effects from the medications used (Edronax, Rilatine, P-Tablets) or discomfort from any assessments. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What chemicals are being studied in my brain?

The study focuses on three natural brain chemicals: serotonin (often called 5-HT), dopamine (DA), and noradrenaline (NA). These are messengers that affect your mood, energy, and how you feel.

What kind of medicines will I be given?

The study mentions using Edronax 4 mg tablets, Rilatine Modified Release 10 mg capsules, and P-Tablets weiß 7mm Lichtenstein. These medications help adjust levels of the brain chemicals being studied.

Will I have to do exercise in the study?

Yes, the study is specifically looking at 'exercise-induced fatigue,' which means it will involve physical activity to see how your brain and body react when you get tired from exercise.

How long will I need to be in the study?

The information provided does not state the exact length of the study, but research studies often involve multiple visits over several weeks or months.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.