Skip to main content
OpenTrials
Completed

NCT Number: NCT04825964

Exercise Capacity, Physical Activity Levels in Patients With Hyperthyroid

The primary aim of the study is to evaluate physical activity level and functional exercise capacity in patients with hyperthyroid. The secondary aim of the study is assessment of respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, fatigue, depression, anxiety, stress, sleep and quality of life in patients with hyperthyroid and compare them with healthy controls.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

About this study

Hyperthyroidism is a pathological disease in which the synthesis and secretion of thyroid hormones are increased by the thyroid gland. Thyroid hormone excess affects many systems. Common clinical symptoms are fatigue, palpitations, disturbed sleep, weight loss, heat intolerance, sweating, tremors, polydipsia, and anxiety. Common physical findings are tachycardia, extremity tremors and weight loss.

Thyroid hormone directly affects skeletal muscles. Increased thyroid hormone causes myopathy with a decrease in muscle strength and mass. Hyperthyroid myopathy can cause a decrease in exercise capacity. The main cause of exercise intolerance in individuals with hyperthyroidism is the change in energy metabolism. The number of studies investigating the exercise capacity in hyperthyroid patients is limited. Information support will be provided to the literature by evaluating the exercise capacity in patients with hyperthyroidism.

Physical activity is positively associated with changes in cardiovascular risk factors. Neuromuscular symptoms and exercise intolerance seen with thyroid hormone excess can lead people to an inactive life. Indirect calorimetry, the gold standard in energy expenditure, has been shown to be highly correlated with metabolic holter.There are no studies evaluating physical activity level with metabolic holter in individuals with hyperthyroidism. In this study, physical activity level will be evaluated by metabolic holter.

Patients with hyperthyroidism referred to the Cardiopulmonary Rehabilitation Unit of Gazi University Physiotherapy and Rehabilitation Department by the physicians of the Department of Endocrinology and Metabolism of the Department of Internal Diseases of Gazi University Faculty of Medicine will be included in the study. Patients and healthy individuals will be evaluated and the evaluation results will be compared. According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. Patients will be evaluated twice. The first evaluation will be made in the new diagnosis. The second evaluation will be made in the euthyroidism.The assessments will be completed in two days.

Functional exercise capacity (6 minutes walk test and 6 minutes stepper test), physical activity level (multi-sensor activity monitor), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), peripheral muscle strength (dynamometer), respiratory muscle endurance (incremental threshold loading test), quality of life (The Thyroid-Related Quality of Life-ThyPRO), fatigue (Fatigue Severity Scale), depression-anxiety-stress (Depression Anxiety Stress Scale-42), quality of sleep (Pittsburgh Sleep Quality Index) and shortness of breath (Modified Medical Research Council (MMRC)) will be evaluated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients group: Patients who are;

  • Individuals diagnosed with hyperthyroidism by a physician
  • Individuals between the ages of 18-70

Exclusion criteria

for patients group: Patients who are;

  • Use of drugs that affect the heart rate (except for short-term beta blockers given to relieve thyrotoxicosis symptoms)
  • having problems that limit physical activity (orthopedic, neurological, psychological)
  • having comorbidities such as uncontrolled hypertension, diabetes mellitus, heart failure or atrial fibrillation
  • use of any medication that may affect thyroid function
  • patients with acute infection during evaluation
  • patients with uncontrolled hypertension, diabetes mellitus

Inclusion criteria

for healthy group: Participants who are;

  • being between ages of 18 and 70
  • willing to participate to the study

Exclusion criteria

for healthy group: Participants who are;

  • having any diagnosis of chronic diseases
  • having health problems such as cooperation
  • having acute infection during evaluation
  • being current smokers
  • being ex-smokers (≥10 pack*years)

Treatment and study plan

Primary outcomes

  1. Functional Exercise Capacity

    Time frame: First Day

    Functional exercise capacity will be evaluated with 6-minutes walking test according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The total distance they walked for 6 minutes in a 30-meter straight corridor will be recorded.

  2. Functional Exercise Capacity

    Time frame: Second Day

    Functional exercise capacity will be evaluated with 6-minutes Stepper Test according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The total number of steps will be recorded for 6 minutes.

  3. Physical activity (Total energy expenditure)

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  4. Physical activity (Physical activity time (min / day))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity time (min / day)will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  5. Physical activity (Active energy expenditure (joule / day))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Active energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  6. Physical activity (Average metabolic equivalent (MET / day))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Average metabolic equivalent (MET / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  7. Physical activity (Number of steps (steps / day))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Number of steps (steps / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  8. Physical activity (Time spent lying down (min / day) days))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Time spent lying down (min / day) days) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

  9. Physical activity (Sleep time (min / day))

    Time frame: Second Day

    Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The patient will be informed about removing the device while taking a bath. Sleep time (min / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.

Secondary outcomes

  1. Respiratory Muscle Strength

    Time frame: First Day

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be measured with a portable mouth pressure measuring device according to ATS and ERS criteria.

  2. Peripheral Muscle Strength

    Time frame: First Day

    Isometric peripheral muscle strength will be measured with a portable hand dynamometer (JTECH Commander, USA). Measurements will be repeated on the shoulder abductors and knee extensors three times on the right and left.

  3. Respiratory Muscle Endurance

    Time frame: Second Day

    Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. The test will be started with 20% of the maximal inspiratory pressure and the pressure will be increased to 40%, 60%, 80% and 100% every two minutes. Patients will be asked to continue breathing through the device during the test. During the test, the number of breaths delivered and the maximal time reached during each 2-minute period will be recorded. If the individual cannot breathe 3 consecutive times, the test will be terminated by the physiotherapist. The total duration of the test and the maximum pressure value at which it continues to breathe for at least 1 minute will be multiplied. The value found will be recorded as the respiratory muscle endurance value.inspiratory pressure with a 20% increment every 2 minutes.

  4. Disease Specific Quality of Life

    Time frame: First Day

    Quality of life was evaluated with the Turkish version of the Quality of Life Scale (ThyPRO) in Thyroid Patients. For each question, a five-point Likert type (0 = not at all, 1 = very little, 2 = a little, 3 = a little bit, 4 = a lot) was used. Each subscale is scored differently. High scores indicate a decreased quality of life.

  5. Fatigue

    Time frame: First Day

    Fatigue will be evaluated using Turkish version of Fatigue Severity Scale. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue)score range for each item from 1 to 7 point (7-point Likert scale).

  6. Shortness of breath

    Time frame: First Day

    The Modified Medical Research Council (MMRC) dyspnea scale will be used to determine the perception of dyspnea during activities of daily living.

    Dyspnea is graded as: zero (shortness of breath with strenuous exercise only); one (shortness of breath when rushing or walking up a slight uphill); two (because of shortness of breath they walk slower than people of the same age or have to stop to breathe while walking at their own pace); three (stops to breathe after walking 100 meters or after a few minutes); and four (too short of breath to leave the house or shortness of breath when getting dressed).daily living activities.

  7. Sleep Quality

    Time frame: First Day

    Sleep quality will be evaluated by Turkish adaptation of Pittsburgh Sleep Quality Index (PSQI). The scale includes 24 questions. The questions included in the scoring consist of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Total PSQI score varies between 0-21. A total score greater than five indicates "poor sleep quality".

  8. Depression Anxiety Stress

    Time frame: First Day

    Depression, Anxiety and Stress Scale (DASS) was evaluated with Turkish version. The scale is a four-digit Likert type scale. The total scores of the scale vary between 0 and 42 for each sub-dimension. A high score indicates that the individual has that problem.

  9. Pulmonary function (Forced vital capacity (FVC))

    Time frame: First Day

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. Forced vital capacity (FVC) will be measured.

  10. Pulmonary function (Forced expiratory volume in the first second (FEV1))

    Time frame: First Day

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. Forced expiratory volume in the first second (FEV1) will be measured.

  11. Pulmonary function (FEV1 / FVC)

    Time frame: First Day

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. FEV1 / FVC will be measured.

  12. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    Time frame: First Day

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.

  13. Pulmonary function (Peak flow rate (PEF))

    Time frame: First Day

    Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. Peak flow rate (PEF) will be measured.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Comparison of Exercise Capacity and Physical Activity Levels in Patients With Hyperthyroid and Healthy Controls

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.