Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma

NCT06163261 | Recruiting

• 1 other identifier: PEPP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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, 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.¨.

Conditions

Non-functioning Pituitary Adenoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• Changes in health status

  At baseline

• Changes in health status

  At 6 months follow up

• Changes in health status

  At 12 months follow up

• Changes in fitness/muscle strength - Cycling

  At baseline

• Changes in fitness/muscle strength - Cycling

  At 6 months follow-up

Study Arms (2)

Intervention group

OTHER

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

Other: Physical activity

Control group

NO INTERVENTION

This group will receive standard care.

Interventions

Physical activity OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska Univesity Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Victor Hantelius, Md

CONTACT

+46704442085; victor.hantelius@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-03

Locations

SE (1)