Exercise Capacity, Physical Activity Levels in Patients With Hyperthyroid

NCT04825964 | Completed

• 1 other identifier: Gazi University 25
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 and quality of life in patients with hyperthyroid and compare them with healthy controls.

Conditions

Hyperthyroidism

Keywords

Hyperthyroidism; Exercise Capacity; Physical Activity

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Second Day

Secondary Outcomes (13)

• Respiratory Muscle Strength

  First Day

• Peripheral Muscle Strength

  First Day

• Respiratory Muscle Endurance

  Second Day

• Disease Specific Quality of Life

  First Day

• Fatigue

  First Day

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 8549218 BACKGROUND

• 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.

  PMID: 1416391 BACKGROUND

• 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.

  PMID: 12213666 BACKGROUND

• 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.

  PMID: 3255983 BACKGROUND

• 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.

  PMID: 8571001 BACKGROUND

• 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.

  PMID: 39593519 DERIVED

MeSH Terms

Conditions

Hyperthyroidism; Motor Activity

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Behavior

Study Officials

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Fidan YILMAZ, Pt

  Gazi University

  STUDY CHAIR

• Afruz BABAYEVA, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

• İlhan YETKİN, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: April 1, 2021
• Study Start: March 19, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)