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 range18 Years – 75 Years
SexALL
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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…