Individualized Physical Activity or 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

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.¨.

Study Overview

• Status: Recruiting
• Conditions: Non-functioning Pituitary Adenoma
• Intervention / Treatment: Other: Physical activity

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victor Hantelius, Md; Phone Number: +46704442085; Email: victor.hantelius@vgregion.se

Study Locations

• Sweden
  • Västra Götaland County
    • Gothenburg, Västra Götaland County, Sweden, 41345
      • Recruiting
      • Sahlgrenska Univesity Hospital
      • Contact: Victor Hantelius, Nurse; Phone Number: +46313422400; Email: anne-charlotte.olofsson@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; This group will receive an individualized and person-centred prescription of physical activity and exercise in addition to standard care.	Other: Physical activity; The intervention group will receive an individualized and person-centred prescription of physical activity and exercise.
No Intervention: Control group; This group will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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..	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..	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..	At 12 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fitness/muscle strength - Cycling	Cycling test	At baseline
Changes in fitness/muscle strength - Cycling	Cycling test	At 6 months follow-up
Changes in fitness/muscle strength - Cycling	Cycling test	At 12 months follow up
Changes in fitness/muscle strength - Hand strength	Hand strength test	At baseline
Changes in fitness/muscle strength - Hand strength	Hand strength test	At 16 months follow up
Changes in fitness/muscle strength - Hand strength	Hand strength test	At 12 months follow up
Changes in fitness/muscle strength - Chair stand	Chair stand test	At baseline
Changes in fitness/muscle strength - Chair stand	Chair stand test	At 6 months follow up
Changes in fitness/muscle strength - Chair stand	Chair stand test	At 12 months follow up
Changes in fitness/muscle strength - Accelerometer	Accelerometer for a week	At baseline
Changes in fitness/muscle strength - Accelerometer	Accelerometer for a week	At 6 months follow up
Changes in fitness/muscle strength - Accelerometer	Accelerometer for a week	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)	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)	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)	At 12 months follow up
Changes in cardiovascular risk profile - Blood samples	Blood lipids	At baseline
Changes in cardiovascular risk profile - Blood samples	Blood lipids	At 6 months follow up
Changes in cardiovascular risk profile - Blood samples	Blood lipids	At 12 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.	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.	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.	At 12 months follow up
Changes in cardiovascular risk profile - Blood pressure	Blood pressure - systolic and diastolic	At baseline
Changes in cardiovascular risk profile - Blood pressure	Blood pressure - systolic and diastolic	At 6 months follow up
Changes in cardiovascular risk profile - Blood pressure	Blood pressure - systolic and diastolic	At 12 months follow up

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: PEPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No