Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma (NCT06163261) | Clinical Trial Compass
RecruitingNot Applicable
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Sweden120 participantsStarted 2024-02-27
Plain-language summary
The goal of this clinical trial is to learn about physical activity's effect on health in people who have had surgery of a non-functioning pituitary adenoma.
The main questions it aims to answer are:
* Do physical activity increase quality of life?
* Do physical activity increase general health, cardiovascular fitness, self-efficacy and muscle strength and reduce fatigue and cardiovascular risk profile?
Participants will at the start of the the study, at 6 months follow up and 12 months follow up:
* Fill out health surveys
* Perform a cycling test, hand strength test, chair stand test and wear and accelerometer for a week
* Undergo a dual energy X-ray absorptiometry to measure muscle and fat mass
* Leave blood samples
Researchers will compare those who are randomized to the intervention and see a physiotherapist to get an individualized and person-centred prescription of physical activity plan and those who are randomized not to be in the intervention to see if physical activity increases quality of life and general health.¨.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with clinically significant non-functioning pituitary adenoma treated with surgery during the last ten years
* Stable hormone replacement therapy ≥ 6 months
* Ability to communicate in Swedish.
Exclusion Criteria:
* Patients with any other pituitary tumors than non-functioning pituitary adenoma
* Patients who possibly need tumor intervention, either with surgery or radiotherapy, within one year
* Other diseases or co-morbidities that may have significant impact on the outcome variables, including:
* Ongoing substance abuse and/or untreated psychiatric disorder, including psychoses and bipolar disease (except treatment with SSRI (Selective Serotonin Reuptake Inhibitor) and or SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) for mild/moderate depression and/or anxiety which is allowed).
* Medical therapy with opioids, sedatives or hypnotics (besides treatment with zopiclone and zolpidem which are allowed).
* Current or previous history of neurological diseases with impaired mobility.
* High alcohol consumption (more than 14 alcohol units per week)
* Ongoing treatment for cancer.
* Uncontrolled hypertension or presence of clinically significant cardiac disease
* Severe respiratory insufficiency.
* Severely impaired hepatic function (ALT (Alanine Aminotransferase) and/or AST (Aspartate Aminotransferase) concentrations two times above the upper limit of normal).
* Severely impaired renal function (Glomerular filtration rate \<45 ml/min).
* Untre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.