ProlactinomaNCT05236829
Exercise Capacity and Physical Activity Level in Prolactinoma Patients
An observational study of Prolactinoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolactinoma
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2021to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Being between the ages of 18-55
- Woman
- Being diagnosed with prolactinoma
- Volunteering to participate in the study
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prolactinoma
- Keywords
- Prolactinoma, exercise capacity, physical activity, quality of life
- Medical subject headings
- Prolactinoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Exercise Capacity
Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).
Measured: 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.
Measured: 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.
Measured: day 1
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start16 Jun 2021
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236829
- Sponsor's protocol ID
- GO21/728
- Status last verified
- May 2024
- First submitted
- 2 Feb 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erkoc A, Eroglu I, Erbas T, Kutukcu EC. Muscle function, exercise capacity, physical activity level and cardiovascular disease risk factor knowledge in patients with prolactinoma. Endocrine. 2024 Sep;85(3):1337-1345. doi: 10.1007/s12020-024-03880-7. Epub 2024 May 27.
PubMed 38801597
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Exercise Capacity, Physical Activity Level and Quality of Life in Prolactinoma Patients and Healthy Individuals
- ClinicalTrials.gov ID
- NCT05236829
- Acronym / sponsor ID
- GO21/728
- Conditions
- Prolactinoma
- Keywords
- Prolactinoma, exercise capacity, physical activity, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Being between the ages of 18-55
- Woman
- Being diagnosed with prolactinoma
- Volunteering to participate in the study
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aerobic Exercise Capacity
Time frame: day 1
Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).
Physical Activity Level
Time frame: day 1
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.
Life quality
Time frame: day 1
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.
4 secondary outcomes
Peripheral Muscle Strength
Time frame: day 1
Peripheral Muscle Endurance
Time frame: day 1
Cardiovascular Diseases Risk Factors Knowledge Level
Time frame: day 1
Fatigue perception
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 38801597Erkoc A, Eroglu I, Erbas T, Kutukcu EC. Muscle function, exercise capacity, physical activity level and cardiovascular disease risk factor knowledge in patients with prolactinoma. Endocrine. 2024 Sep;85(3):1337-1345. doi: 10.1007/s12020-024-03880-7. Epub 2024 May 27.
- Individual participant dataSharing planned: Undecided
Related trials for Prolactinoma
RecruitingObservational study
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Active, not recruitingObservational study
Long Term Outcome Study in Patients With Pituitary Disorders
Pituitary Diseases, Pituitary Neoplasms
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
RecruitingPhase 2
A Study of Pasireotide in People With Prolactinoma
Prolactin-Producing Pituitary Tumor
Active, not recruitingObservational study
The PROMISE Survey
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolactinoma, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Exercise Capacity (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.