Individualized physical activity program for patients with non-functioning pituitary adenoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of an individualized physical activity program on the health and quality of life of patients who have undergone surgery for non-functioning pituitary adenoma. Participants will be randomly assigned to either an intervention group, receiving a tailored exercise plan from a physiotherapist, or a control group receiving standard care. The study will assess various health metrics, including cardiovascular fitness, muscle strength, and fatigue levels, through surveys and physical tests at multiple follow-up points. Blood samples and body composition measurements will also be taken to monitor health changes over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sahlgrenska Univesity Hospital
  Gothenburg, Västra Götaland County, Sweden Recruiting

Study contacts

• Study coordinator: Victor Hantelius, Md
• Email: victor.hantelius@vgregion.se
• Phone: +46704442085

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.