Status:
RECRUITING
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Non-functioning Pituitary Adenoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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:...
Detailed Description
This study is an unblinded, prospective, randomized, controlled trial where 120 participants will be assigned to either an intervention group or a control group - 60 in each arm. The intervention will...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06163261
Start Date
February 27 2024
End Date
December 31 2027
Last Update
September 17 2025
Active Locations (1)
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1
Sahlgrenska Univesity Hospital
Gothenburg, Västra Götaland County, Sweden, 41345