NCT06163261 Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 120 participants in total. It began in 2024-02-27 with a primary completion date of 2026-12-31.

Brief 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.¨.

Eligibility Criteria

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). * Untreated hypo- or hyperthyroidism * Pregnancy or breast feeding.

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