Exercise Capacity and Physical Activity Level in Prolactinoma Patients

May 23, 2024 updated by: Ebru Calik Kutukcu, Hacettepe University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aerobic Exercise Capacity
Time Frame: day 1
Exercise capacity levels of individuals will be evaluated with the 6-Minute Walking Test (6MWT).
day 1
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.
day 1
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.
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peripheral Muscle Strength
Time Frame: day 1
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
Peripheral Muscle Endurance
Time Frame: day 1
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
Cardiovascular Diseases Risk Factors Knowledge Level
Time Frame: day 1
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
Fatigue perception
Time Frame: day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University, Faculty of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO21/728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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