Clinical Trial Finder

Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

Study Purpose

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.¨.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06163261
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Vastra Gotaland Region
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Non-functioning Pituitary Adenoma
Additional Details

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 receive an individualized and person-centred prescription of physical activity and exercise. The control group will get standard care. Inclusion criteria.
  • - Patients with non-functioning pituitary adenoma treated with surgery the last ten years.
  • - Stable hormone replacement therapy ≥ 6 months.
  • - Age 18-75 years.
  • - Ability to communicate in Swedish.
Exclusion criteria.
  • - Patients with other pituitary tumours than non-functioning pituitary adenoma.
  • - Patients who could need tumour intervention (surgery or radiotherapy), within one year.
  • - Co-morbidities that could have significant impact on the outcome variables.
After the randomization, patients in intervention arm will meet a physiotherapist and a research nurse. The participants will be asked to describe their life situation and experiences regarding their health, diseases, physical activity and exercise and after this be given an individualized and person-centred prescription of physical activity. The exercise will be documented in the self-care plan. In order to assess participants adherence to exercise, participants will be informed to document their performed exercise in the self-care plan during the first 12 weeks. All patients in the intervention group will be followed at 4, 8 and 12 weeks after inclusion in the study when they meet with the same nurse and physiotherapist as at the first visit. Regarding outcome measures the primary endpoint and the secondary endpoints and will be measured at baseline, and at 6 and 12 months for both the intervention group and the standard care group. The primary endpoint is quality of life and the secondary endpoints are changes in health status, physical activity, cardiorespiratory fitness, muscle strength, self-reported fatigue and self-efficacy, and changes in cardiovascular risk profile. To assess this the participant will:
  • - 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

Arms & Interventions

Arms

Other: Intervention group

This group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care.

No Intervention: Control group

This group will receive standard care.

Interventions

Other: - Physical activity

The intervention group will receive an individualized and person-centred prescription of physical activity and exercise.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sahlgrenska Univesity Hospital, Gothenburg, Vastra Gotaland, Sweden

Status

Recruiting

Address

Sahlgrenska Univesity Hospital

Gothenburg, Vastra Gotaland, 41345

Site Contact

Victor Hantelius, Nurse

[email protected]

+46313422400

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