Exercise Capacity and Physical Activity Level in Prolactinoma Patients

NCT05236829 | Completed

• 1 other identifier: GO21/728
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Prolactinoma, one of the most common pituitary adenomas, is an adenoma that causes excessive prolactin (PRL) secretion. An increase in prolactin level can cause weakness, decrease in muscle mass and fatigue. It is not known in detail to what extent it affects quality of life, functional exercise capacity, cardiovascular disease risk factors, physical activity level, fatigue and sleep quality in prolactinoma patients. It is aimed to compare how much exercise capacity, physical activity level, sleep quality, perception of fatigue and quality of life of prolactinoma patients are affected compared to healthy individuals and to examine the factors associated with exercise capacity in prolactinoma patients.

Conditions

Prolactinoma

Keywords

Prolactinoma; exercise capacity; physical activity; quality of life

Outcome Measures

Primary Outcomes (3)

• Aerobic Exercise Capacity

  Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).

  day 1

• Physical Activity Level

  Physical activity level will be evaluated with the Turkish version of the short form of the International Physical Activity Questionnaire (IPAQ). The scale consists of 7 questions. Activities and sitting time in the last 1 week are recorded in minutes.

  day 1

• Life quality

  The Pittsburgh Sleep Quality Index (PUKI) will be used to assess sleep quality. The scale has eight sub-parameters and consists of 36 items. Scoring is between 0 and 100. Higher scores indicate better health-related quality of life.

  day 1

Secondary Outcomes (4)

• Peripheral Muscle Strength

  day 1

• Peripheral Muscle Endurance

  day 1

• Cardiovascular Diseases Risk Factors Knowledge Level

  day 1

• Fatigue perception

  day 1

Study Arms (2)

Healthy group

Healthy women aged 18-55 who have not been diagnosed with any chronic disease and pituitary adenoma

Patient with Prolactinoma group

Women between the ages of 18-55 diagnosed with Prolactinoma

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy group: Individuals between the ages of 18-55, female, not diagnosed with a pituitary adenoma, volunteered to participate in the study. Patient group: Individuals aged 18-55, female, diagnosed with prolactinoma, volunteered to participate in the study.

You may qualify if:

• Being between the ages of 18-55
• Woman
• Being diagnosed with prolactinoma
• Volunteering to participate in the study

You may not qualify if:

• Patients with neurological, cognitive or orthopedic disease that will affect the measurements
• Patients with severe respiratory disease (FEV1 \< 35%; FVC \< 50%)
• Presence of acute infection
• Presence of malignancy
• Presence of dementia
• Patients who have had a cardiovascular event in the last 6 months
• Less than 50% of the ejection fraction
• Patients with uncontrolled hypertension
• Individuals with a diagnosis of uncontrolled diabetes mellitus will not be included in the study.
• Being between the ages of 18-55
• Woman
• Not being diagnosed with any pituitary adenoma
• Volunteering to participate in the study
• Cases with neurological, cognitive or orthopedic diseases that will affect the measurements
• Cases with severe respiratory disease (FEV1 \< 35%; FVC \< 50%)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Erkoc A, Eroglu I, Erbas T, Kutukcu EC. Muscle function, exercise capacity, physical activity level and cardiovascular disease risk factor knowledge in patients with prolactinoma. Endocrine. 2024 Sep;85(3):1337-1345. doi: 10.1007/s12020-024-03880-7. Epub 2024 May 27.

  PMID: 38801597 DERIVED

MeSH Terms

Conditions

Prolactinoma; Motor Activity

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pituitary Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Behavior

Study Officials

• Ebru Calik Kutukcu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: June 16, 2021
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TU (1)