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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05236829
Enrollment
38
Registered
2022-02-11
Start date
2021-06-16
Completion date
2022-10-15
Last updated
2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolactinoma

Keywords

Prolactinoma, exercise capacity, physical activity, quality of life

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.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Aerobic Exercise Capacityday 1Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).
Physical Activity Levelday 1Physical 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.
Life qualityday 1The 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.

Secondary

MeasureTime frameDescription
Peripheral Muscle Strengthday 1Knee 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.
Fatigue perceptionday 1Individuals' 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.
Peripheral Muscle Enduranceday 1Evaluation 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.
Cardiovascular Diseases Risk Factors Knowledge Levelday 1Individuals' 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026