Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Recruiting now · Not applicable
Conditions studied: Non-functioning Pituitary Adenoma
In brief
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.¨.
Key facts
- Study ID
- NCT06163261
- Run by
- Vastra Gotaland Region
- People needed
- 120
- Starts
- 2024-02-27
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sahlgrenska Univesity Hospital — Gothenburg, Västra Götaland County, Sweden (enrolling)
Full record on ClinicalTrials.gov
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