Individualized physical activity program for 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
This study is testing if a personalized exercise program can improve the health and quality of life for patients who have had surgery for non-functioning pituitary adenoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT06163261 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have had surgery for non-functioning pituitary adenoma within the last ten years and are stable on hormone replacement therapy.
Not a fit: Patients with other types of pituitary tumors or those requiring further tumor intervention within a year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and overall health for patients recovering from non-functioning pituitary adenoma surgery.
How similar studies have performed: While similar studies have explored physical activity's benefits in various conditions, this specific approach for non-functioning pituitary adenoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg, Västra Götaland County
- Sahlgrenska Univesity Hospital — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Study coordinator: Victor Hantelius, Md
- Email: victor.hantelius@vgregion.se
- Phone: +46704442085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.