Exercise Capacity and Physical Activity Level in Prolactinoma Patients

Prolactinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236829
• Other study ID #: GO21/728
• Status: Completed
• Start date: June 16, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prolactinoma

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic Exercise Capacity	Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).	day 1
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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