Clinical trial NCT04825964: Exercise Capacity, Physical Activity Levels in Patients With Hyperthyroid
Official title: Comparison of Exercise Capacity and Physical Activity Levels in Patients With Hyperthyroid and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthyroidism
Keywords: Hyperthyroidism
Exercise Capacity
Physical Activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Functional Exercise Capacity
timeFrame: First Day
measure: Functional Exercise Capacity
timeFrame: Second Day
measure: Physical activity (Total energy expenditure)
timeFrame: Second Day
measure: Physical activity (Physical activity time (min / day))
timeFrame: Second Day
measure: Physical activity (Active energy expenditure (joule / day))
timeFrame: Second Day
measure: Physical activity (Average metabolic equivalent (MET / day))
timeFrame: Second Day
measure: Physical activity (Number of steps (steps / day))
timeFrame: Second Day
measure: Physical activity (Time spent lying down (min / day) days))
timeFrame: Second Day
measure: Physical activity (Sleep time (min / day))
timeFrame: Second Day
Secondary outcomes:
measure: Respiratory Muscle Strength
timeFrame: First Day
measure: Peripheral Muscle Strength
timeFrame: First Day
measure: Respiratory Muscle Endurance
timeFrame: Second Day
measure: Disease Specific Quality of Life
timeFrame: First Day
measure: Fatigue
timeFrame: First Day
measure: Shortness of breath
timeFrame: First Day
measure: Sleep Quality
timeFrame: First Day
measure: Depression Anxiety Stress
timeFrame: First Day
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: First Day
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: First Day
measure: Pulmonary function (FEV1 / FVC)
timeFrame: First Day
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: First Day
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: First Day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Fidan YILMAZ, Pt
role: STUDY_CHAIR
affiliation: Gazi University
name: Afruz BABAYEVA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İlhan YETKİN, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.