Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

Vastra Gotaland Region

Status

Enrolling

Conditions

Non-functioning Pituitary Adenoma

Treatments

Other: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT06163261

PEPP

Details and patient eligibility

About

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.¨.

Full 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 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

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.