Exercise Capacity and Physical Activity Level in Prolactinoma Patients

NCT ID: NCT05236829

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-10-15

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.

Detailed Description

Prolactinoma is a pituitary adenoma caused by excessive prolactin secretion. More than 70% of patients are women. Many physiological conditions such as pregnancy, breastfeeding, breast stimulation, stress, exercise and sleep can also increase PRL levels. Prolactin can affect arterial stiffness and blood pressure and cause atherosclerosis in early menopause. In addition to these, it has negative effects on heart rhythm and heart failure. In addition to these clinical findings, the extent to which body weight gain and fatigue symptoms affect quality of life, functional exercise capacity, cardiovascular disease risk factors, physical activity level, fatigue and sleep quality in prolactinoma patients is not known in detail. There are very few studies on these subjects. Height, weight, waist circumference, hip circumference will be measured for all participants, waist-hip ratio and body mass index (BMI) will be calculated. The exercise capacity levels of the individuals who will participate in the study will be evaluated with the 6 Minute Walk Test (6MWT). Risk factors knowledge levels about cardiovascular diseases will be evaluated with Cardiovascular Diseases Risk Factors Knowledge Level (CARRIF-BD) Scale. Physical activity level will be evaluated with the Turkish version of the short form of the International Physical Activity Questionnaire (IPAQ). The Pittsburgh Sleep Quality Index (PUKI) was used to evaluate sleep quality. Fatigue assessment will be evaluated with the Multidimensional Fatigue Rating Scale. quality of life will be evaluated with the SF-36 short form. Measurement of knee extensor muscle strength will be made with a portable digital dynamometer (JTECH, Medical Commander Powertrack II, Midvale, USA). Peripheral muscle endurance assessment will be done by bilateral squat test.

Conditions

Prolactinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy group

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

No interventions assigned to this group

Patient with Prolactinoma group

Women between the ages of 18-55 diagnosed with Prolactinoma

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Being between the ages of 18-55
• Woman
• Not being diagnosed with any pituitary adenoma
• Volunteering to participate in the study

Exclusion Criteria

• 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.

• Cases with neurological, cognitive or orthopedic diseases that will affect the measurements
• Cases with severe respiratory disease (FEV1 < 35%; FVC < 50%)
• Presence of acute infection
• Presence of malignancy
• Presence of dementia
• Cases who have had a cardiovascular event in the last 6 months
• Less than 50% of the ejection fraction
• Patients with uncontrolled hypertension
• Cases with uncontrolled diabetes mellitus diagnosis will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Calik Kutukcu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Calik Kutukcu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 38801597 (View on PubMed)

Other Identifiers

GO21/728

Identifier Type: -

Identifier Source: org_study_id