Non-functioning Pituitary AdenomaNCT06163261
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
A study testing Physical activity in people with Non-functioning Pituitary Adenoma, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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: Do physical activity increase quality of life? Do physical activity increase general health, cardiovascular fitness… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-functioning Pituitary Adenoma
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 27 Feb 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Univesity Hospital
Gothenburg, Västra Götaland County, 41345
Victor Hantelius, Nurse, +46313422400, anne-charlotte.olofsson@vgregion.se
About this study
Official title: Individualized and Person-centred Physical Activity and Exercise for Patients With Non Functioning Pituitary Adenoma - A Randomized Controlled Trial
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:
Read more
- 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.¨.
Read the 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 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
- Conditions
- Non-functioning Pituitary Adenoma
- Being tested
- Physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
The intervention group will receive an individualized and person-centred prescription of physical activity and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | This group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care. Receives: Other: Physical activity |
| Control group | No intervention | This group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
Measured: At baseline
Changes in quality of life
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
Measured: At 6 months follow up
Changes in quality of life
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
Measured: At 12 months follow up
Secondary outcomes (24)
Changes in health status
Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state.
Measured: At baseline
Changes in health status
Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state.
Measured: At 6 months follow up
Changes in health status
Measured with EuroQol-5D (EQ5D). The EuroQol-5D (EQ-5D) index ranges from 0 to 1, where 1 represents the best possible health state, and a visual analog scale (VAS), a scale from 0 to 100, with 100 representing the best imaginable health state.
Measured: At 12 months follow up
Changes in fitness/muscle strength - Cycling
Cycling test
Measured: At baseline
Changes in fitness/muscle strength - Cycling
Cycling test
Measured: At 6 months follow-up
Changes in fitness/muscle strength - Cycling
Cycling test
Measured: At 12 months follow up
Changes in fitness/muscle strength - Hand strength
Hand strength test
Measured: At baseline
Changes in fitness/muscle strength - Hand strength
Hand strength test
Measured: At 16 months follow up
Changes in fitness/muscle strength - Hand strength
Hand strength test
Measured: At 12 months follow up
Changes in fitness/muscle strength - Chair stand
Chair stand test
Measured: At baseline
Changes in fitness/muscle strength - Chair stand
Chair stand test
Measured: At 6 months follow up
Changes in fitness/muscle strength - Chair stand
Chair stand test
Measured: At 12 months follow up
Changes in fitness/muscle strength - Accelerometer
Accelerometer for a week
Measured: At baseline
Changes in fitness/muscle strength - Accelerometer
Accelerometer for a week
Measured: At 6 months follow up
Changes in fitness/muscle strength - Accelerometer
Accelerometer for a week
Measured: At 12 months follow up
Changes in self-reported self-efficacy
Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10)
Measured: At baseline
Changes in self-reported self-efficacy
Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10)
Measured: At 6 months follow up
Changes in self-reported self-efficacy
Self-reported self-efficacy through Self-Efficacy t Manage Chronic Disease (a questionnaire with 6 question where you rate yourself 1-10)
Measured: At 12 months follow up
Changes in cardiovascular risk profile - Blood pressure
Blood pressure - systolic and diastolic
Measured: At baseline
Changes in cardiovascular risk profile - Blood pressure
Blood pressure - systolic and diastolic
Measured: At 6 months follow up
Changes in cardiovascular risk profile - Blood pressure
Blood pressure - systolic and diastolic
Measured: At 12 months follow up
Changes in cardiovascular risk profile - Blood samples
Blood lipids
Measured: At baseline
Changes in cardiovascular risk profile - Blood samples
Blood lipids
Measured: At 6 months follow up
Changes in cardiovascular risk profile - Blood samples
Blood lipids
Measured: At 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start27 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-functioning Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163261
- Sponsor's protocol ID
- PEPP
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized and Person-centred Physical Activity and Exercise for Patients With Non Functioning Pituitary Adenoma - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06163261
- Acronym / sponsor ID
- PEPP
- Conditions
- Non-functioning Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.¨.
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 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Physical activityThis group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care. |
| Control group | No intervention | –This group will receive standard care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe intervention group will receive an individualized and person-centred prescription of physical activity and exercise. | Other | Intervention group |
Primary outcome
Changes in quality of life
Time frame: At baseline
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
Changes in quality of life
Time frame: At 6 months follow up
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
Changes in quality of life
Time frame: At 12 months follow up
Measured with the Short Form Survey Instrument (SF-36), where the score is transformed to a scale 0-100 where 100 represents be best possible health status and quality of life..
24 secondary outcomes
Changes in health status
Time frame: At baseline
Changes in health status
Time frame: At 6 months follow up
Changes in health status
Time frame: At 12 months follow up
Changes in fitness/muscle strength - Cycling
Time frame: At baseline
Changes in fitness/muscle strength - Cycling
Time frame: At 6 months follow-up
Changes in fitness/muscle strength - Cycling
Time frame: At 12 months follow up
Changes in fitness/muscle strength - Hand strength
Time frame: At baseline
Changes in fitness/muscle strength - Hand strength
Time frame: At 16 months follow up
Changes in fitness/muscle strength - Hand strength
Time frame: At 12 months follow up
Changes in fitness/muscle strength - Chair stand
Time frame: At baseline
Changes in fitness/muscle strength - Chair stand
Time frame: At 6 months follow up
Changes in fitness/muscle strength - Chair stand
Time frame: At 12 months follow up
Changes in fitness/muscle strength - Accelerometer
Time frame: At baseline
Changes in fitness/muscle strength - Accelerometer
Time frame: At 6 months follow up
Changes in fitness/muscle strength - Accelerometer
Time frame: At 12 months follow up
Changes in self-reported self-efficacy
Time frame: At baseline
Changes in self-reported self-efficacy
Time frame: At 6 months follow up
Changes in self-reported self-efficacy
Time frame: At 12 months follow up
Changes in cardiovascular risk profile - Blood pressure
Time frame: At baseline
Changes in cardiovascular risk profile - Blood pressure
Time frame: At 6 months follow up
Changes in cardiovascular risk profile - Blood pressure
Time frame: At 12 months follow up
Changes in cardiovascular risk profile - Blood samples
Time frame: At baseline
Changes in cardiovascular risk profile - Blood samples
Time frame: At 6 months follow up
Changes in cardiovascular risk profile - Blood samples
Time frame: At 12 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Non-functioning Pituitary Adenoma, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Hantelius, Md (+46704442085, victor.hantelius@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.