Clinical trial NCT05236829: Exercise Capacity and Physical Activity Level in Prolactinoma Patients
Official title: Comparison of Exercise Capacity, Physical Activity Level and Quality of Life in Prolactinoma Patients and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolactinoma
Keywords: Prolactinoma
exercise capacity
physical activity
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aerobic Exercise Capacity
timeFrame: day 1
measure: Physical Activity Level
timeFrame: day 1
measure: Life quality
timeFrame: day 1
Secondary outcomes:
measure: Peripheral Muscle Strength
timeFrame: day 1
measure: Peripheral Muscle Endurance
timeFrame: day 1
measure: Cardiovascular Diseases Risk Factors Knowledge Level
timeFrame: day 1
measure: Fatigue perception
timeFrame: day 1
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: PRINCIPAL_INVESTIGATOR
References: