HyperthyroidismNCT04825964

Exercise Capacity, Physical Activity Levels in Patients With Hyperthyroid

An observational study of Hyperthyroidism, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hyperthyroidism
How many people: 30 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 19 Mar 2021to 31 Dec 2021
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: At least 15 patients with hyperthyroid will be included in patients group and 15 healthy individuals will be included in control group

Who may be able to join

Individuals diagnosed with hyperthyroidism by a physician
Individuals between the ages of 18-70
being between ages of 18 and 70
willing to participate to the study

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

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

Read the detailed description

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.

Conditions: Hyperthyroidism
Keywords: Hyperthyroidism, Exercise Capacity, Physical Activity
Medical subject headings: Hyperthyroidism, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04825964
Study group	Role	What they receive
Patients		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 at diagnosis and after 1-3 months.
Healthy Controls		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 one time.

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Exercise Capacity
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.
Measured: First Day
Functional Exercise Capacity
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.
Measured: Second Day
Physical activity (Total energy expenditure)
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.
Measured: Second Day
Physical activity (Physical activity time (min / 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.
Measured: Second Day
Physical activity (Active energy expenditure (joule / 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.
Measured: Second Day
Physical activity (Average metabolic equivalent (MET / 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.
Measured: Second Day
Physical activity (Number of steps (steps / 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.
Measured: Second Day
Physical activity (Time spent lying down (min / day) days))
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.
Measured: Second Day
Physical activity (Sleep time (min / 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.
Measured: Second Day

Secondary outcomes (13)

Respiratory Muscle Strength
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.
Measured: First Day
Peripheral Muscle Strength
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.
Measured: First Day
Respiratory Muscle Endurance
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.
Measured: Second Day
Disease Specific Quality of Life
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.
Measured: First Day
Fatigue
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).
Measured: First Day
Shortness of breath
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.
Measured: First Day
Sleep Quality
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".
Measured: First Day
Depression Anxiety Stress
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.
Measured: First Day
Pulmonary function (Forced vital capacity (FVC))
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.
Measured: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
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.
Measured: First Day
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society guidelines. FEV1 / FVC will be measured.
Measured: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
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.
Measured: First Day
Pulmonary function (Peak flow rate (PEF))
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.
Measured: First Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 202131 Dec 2021

First posted1 Apr 2021
Study start19 Mar 2021
Primary completion30 Nov 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HyperthyroidismStudies of the same condition, open and under way.
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: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04825964
Sponsor's protocol ID: Gazi University 25
Status last verified: Mar 2022
First submitted: 20 Mar 2021
Last updated: 22 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kahaly G, Hellermann J, Mohr-Kahaly S, Treese N. Impaired cardiopulmonary exercise capacity in patients with hyperthyroidism. Chest. 1996 Jan;109(1):57-61. doi: 10.1378/chest.109.1.57.
PubMed 8549218
Siafakas NM, Milona I, Salesiotou V, Filaditaki V, Tzanakis N, Bouros D. Respiratory muscle strength in hyperthyroidism before and after treatment. Am Rev Respir Dis. 1992 Oct;146(4):1025-9. doi: 10.1164/ajrccm/146.4.1025.
PubMed 1416391
Goswami R, Guleria R, Gupta AK, Gupta N, Marwaha RK, Pande JN, Kochupillai N. Prevalence of diaphragmatic muscle weakness and dyspnoea in Graves' disease and their reversibility with carbimazole therapy. Eur J Endocrinol. 2002 Sep;147(3):299-303. doi: 10.1530/eje.0.1470299.
PubMed 12213666
Kendrick AH, O'Reilly JF, Laszlo G. Lung function and exercise performance in hyperthyroidism before and after treatment. Q J Med. 1988 Aug;68(256):615-27.
PubMed 3255983
McAllister RM, Delp MD, Laughlin MH. Thyroid status and exercise tolerance. Cardiovascular and metabolic considerations. Sports Med. 1995 Sep;20(3):189-98. doi: 10.2165/00007256-199520030-00005.
PubMed 8571001
Yilmaz F, Babayeva A, Yetkin I, Bosnak-Guclu M. Comparison of exercise capacity and physical activity in patients with hyperthyroidism and controls. J Bodyw Mov Ther. 2024 Oct;40:1752-1760. doi: 10.1016/j.jbmt.2024.10.029. Epub 2024 Oct 15.
PubMed 39593519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperthyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Exercise Capacity and Physical Activity Levels in Patients With Hyperthyroid and Healthy Controls
ClinicalTrials.gov ID: NCT04825964
Acronym / sponsor ID: Gazi University 25
Conditions: Hyperthyroidism
Keywords: Hyperthyroidism, Exercise Capacity, Physical Activity
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: 19 Mar 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 1 Apr 2021 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patients	–	–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 at diagnosis and after 1-3 months.
Healthy Controls	–	–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 one time.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: At least 15 patients with hyperthyroid will be included in patients group and 15 healthy individuals will be included in control group

Key inclusion criteria (4 listed)

Individuals diagnosed with hyperthyroidism by a physician
Individuals between the ages of 18-70
being between ages of 18 and 70
willing to participate to the study

Key exclusion criteria (11 listed)

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

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

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.
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.
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.
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.
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.
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.
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.
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.
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.

13 secondary outcomes

Respiratory Muscle Strength
Time frame: First Day
Peripheral Muscle Strength
Time frame: First Day
Respiratory Muscle Endurance
Time frame: Second Day
Disease Specific Quality of Life
Time frame: First Day
Fatigue
Time frame: First Day
Shortness of breath
Time frame: First Day
Sleep Quality
Time frame: First Day
Depression Anxiety Stress
Time frame: First Day
Pulmonary function (Forced vital capacity (FVC))
Time frame: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: First Day
Pulmonary function (FEV1 / FVC)
Time frame: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First Day
Pulmonary function (Peak flow rate (PEF))
Time frame: First Day

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 22 Mar 2022.
Background: PubMed 8549218Kahaly G, Hellermann J, Mohr-Kahaly S, Treese N. Impaired cardiopulmonary exercise capacity in patients with hyperthyroidism. Chest. 1996 Jan;109(1):57-61. doi: 10.1378/chest.109.1.57.
Background: PubMed 1416391Siafakas NM, Milona I, Salesiotou V, Filaditaki V, Tzanakis N, Bouros D. Respiratory muscle strength in hyperthyroidism before and after treatment. Am Rev Respir Dis. 1992 Oct;146(4):1025-9. doi: 10.1164/ajrccm/146.4.1025.
Background: PubMed 12213666Goswami R, Guleria R, Gupta AK, Gupta N, Marwaha RK, Pande JN, Kochupillai N. Prevalence of diaphragmatic muscle weakness and dyspnoea in Graves' disease and their reversibility with carbimazole therapy. Eur J Endocrinol. 2002 Sep;147(3):299-303. doi: 10.1530/eje.0.1470299.
Background: PubMed 3255983Kendrick AH, O'Reilly JF, Laszlo G. Lung function and exercise performance in hyperthyroidism before and after treatment. Q J Med. 1988 Aug;68(256):615-27.
Background: PubMed 8571001McAllister RM, Delp MD, Laughlin MH. Thyroid status and exercise tolerance. Cardiovascular and metabolic considerations. Sports Med. 1995 Sep;20(3):189-98. doi: 10.2165/00007256-199520030-00005.
Derived from this study: PubMed 39593519Yilmaz F, Babayeva A, Yetkin I, Bosnak-Guclu M. Comparison of exercise capacity and physical activity in patients with hyperthyroidism and controls. J Bodyw Mov Ther. 2024 Oct;40:1752-1760. doi: 10.1016/j.jbmt.2024.10.029. Epub 2024 Oct 15.
Individual participant dataSharing planned: No

Related trials for Hyperthyroidism

RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Active, not recruitingPhase 2
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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.

Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director

Gazi University

Fidan YILMAZ, Pt study chair

Gazi University

Afruz BABAYEVA, MD principal investigator

Gazi 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 Hyperthyroidism, run by Gazi 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 11 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 22 Mar 2022. 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?

Functional Exercise Capacity (time frame: First Day). The study lists 9 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 NCT04825964, which also lists 6 linked publications.

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 22 Mar 2022.