Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

Launched by VASTRA GOTALAND REGION · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to understand how physical activity affects the health and well-being of people who have had surgery for a non-functioning pituitary adenoma, which is a type of tumor that doesn't produce hormones. The main goals are to see if getting more active can improve quality of life, general health, fitness levels, and muscle strength, while also reducing feelings of tiredness and the risk of heart problems.

To participate, you should be between 18 and 75 years old, have had surgery for a non-functioning pituitary adenoma in the last ten years, and have been on stable hormone replacement therapy for at least six months. During the study, you will complete health surveys, do some physical tests, wear a device to track your activity for a week, and provide blood samples. Some participants will work with a physiotherapist to create a personalized exercise plan, while others will not. This will help researchers find out if a tailored physical activity program can really make a difference in health outcomes for patients like you.

Gender

ALL

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.