Prolactinoma Clinical Trial
Official title:
Comparison of Exercise Capacity, Physical Activity Level and Quality of Life in Prolactinoma Patients and Healthy Individuals
NCT number | NCT05236829 |
Other study ID # | GO21/728 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 16, 2021 |
Est. completion date | October 15, 2022 |
Verified date | May 2024 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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 |
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