Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Individualized and Person-centred Physical Activity and Exercise for Patients With Non Functioning Pituitary Adenoma - A Randomized Controlled Trial
Vastra Gotaland Region
120 participants
Feb 27, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria14
- 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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Interventions
The intervention group will receive an individualized and person-centred prescription of physical activity and exercise.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06163261