Exercise Capacity and Physical Activity Level in Prolactinoma Patients

Comparison of Exercise Capacity, Physical Activity Level and Quality of Life in Prolactinoma Patients and Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Prolactinoma

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria of patients:

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

Exclusion Criteria of the patients :

• 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.

Healthy group inclusion criteria:

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

Healthy group exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Muscle Strength	Knee extensor muscle strength will be measured in individuals in sitting position and knee extension. 3 repetitions will be applied for the right and left sides and the results will be recorded in kilograms.	day 1
Peripheral Muscle Endurance	Evaluation will be done with bilateral squat test. Participants initially stand with hips and shoulders in line, knees fully extended, then squat with knees flexed to 90°, then return to starting position. The exact number of repetitions performed in 30 seconds is recorded.	day 1
Cardiovascular Diseases Risk Factors Knowledge Level	Individuals' knowledge of risk factors about cardiovascular diseases will be evaluated with the Cardiovascular Diseases Risk Factors Knowledge Level (CARRIF-BD) Scale. The scale consists of 28 items. It is concluded that the higher the scale score, the higher the level of knowledge of the individual.	day 1
Fatigue perception	Individuals' fatigue perception will be assessed by Multidimensional Assessment of Fatigue (MAF) Scale. The scores to be taken from the scale vary between 1-50. As the scores increase, the level of fatigue also increases.	day 1

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Hacettepe University, Faculty of Medicine
• Investigators: Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; quality of life; exercise capacity; Prolactinoma
• 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; Pituitary Diseases; Adenoma; Pituitary Neoplasms; Prolactinoma
• Other Study ID Numbers: GO21/728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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