Clinical trial NCT05088317: Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
Official title: The Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
exercise capacity
physical activity
sleep apnea
quality of life
anxiety
depression
hand grip strength
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The obese population will consist of participants diagnosed with obesity (BMI\> 30 kg/m\^2), followed by the Tuzla State Hospital Internal Diseases unit in the Tuzla district of Istanbul. The healthy participant population will consist of healthy male and female individuals residing in Istanbul, between the ages of 20 and 65, who have not been diagnosed with obesity.

Brief summary: Volunteer female and male individuals aged 20-65 years, followed in the State Hospital Internal Diseases Unit, diagnosed with obesity (BMI\> 30 kg/m\^2), and meeting the inclusion criteria will be included in the study. The control group will consist of healthy male and female individuals between the ages of 20-65 who have not been diagnosed with obesity. The demographic and clinical characteristics of the participants who voluntarily accepted to participate in the study will be questioned with the "Evaluation Form" prepared by the researchers, and the body compositions of the participants will be evaluated. The "Charlson Comorbidity Index (CCI)" will be used to determine the existing chronic diseases of the participants and to evaluate participants' comorbidities. Next; the "Incremental Shuttle Walk Test (ISWT)" will be applied to determine exercise capacity. In addition, in order to determine the level of physical activity, a "pedometer" device will be given to the participants, participants will be asked to carry the device on them for 7 days, and at the end of the period, the pedometer data will be recorded. At the same time, participants will be required to fill in the "International Physical Activity Questionnaire-Short Form (IPAQ-SF)". Participants will be asked to fill in the "Stop-Bang Test" to assess the risk of sleep apnea, the "Obesity-Specific Quality of Life Scale (OSQOL)" to assess the health-related quality of life, and the "Hospital Anxiety and Depression Scale (HADS)" to determine the anxiety and depression level of the participants. Handgrip strength will be evaluated with a hydraulic hand dynamometer. Assessments take an average of 45 minutes is planned.

Detailed description: Obesity is a serious public health problem whose prevalence is increasing day by day and is accepted as an epidemic by the World Health Organization. Obesity; increases the risk of developing cardiovascular and metabolic disorders such as atherosclerosis, type II diabetes and metabolic syndrome, but also leads to some types of cancer and many musculoskeletal disorders. In addition to all these negative diseases and syndromes, obese individuals often experience a significant deterioration in their physical functions. At the same time, the sedentary lifestyle, which is common in obese individuals, causes a decrease in exercise capacity, which negatively affects the ability to perform activities of daily living. Studies have shown that decreased exercise capacity is strongly correlated with the risk of all-cause mortality. In addition, patients with low exercise capacity have a higher risk of regaining the lost weight. Therefore, increasing exercise capacity is an important goal in obesity management as well as reducing body weight. Studies show that obese individuals are generally at risk for low physical activity levels, sleep apnea syndrome and low quality of life. On the other hand, there is not enough information about the relationship between exercise capacity, physical activity level, sleep apnea risk and quality of life in obese adults. Exercise capacity; investigation of its relationship with physical activity level, sleep apnea risk and quality of life will give an idea about the effect of exercise on these parameters if exercise capacity is increased with a comprehensive exercise program to be prepared for obese individuals. In conclusion, the aim of the study was to evaluate exercise capacity in obese adults and to investigate the relationship between exercise capacity, physical activity level, sleep apnea risk and quality of life.

Eligibility criteria: Inclusion criteria for obese participants:

* Between the ages of 20-65
* With BMI\>30 kg/m\^2

Inclusion criteria for healthy participants:

* Between the ages of 20-65
* With BMI\<30 kg/m\^2

Exclusion Criteria:

* Pregnancy
* Uncontrollable hypertension
* Uncontrolled diabetes requires the use of insulin
* Chronic lung diseases (COPD, etc.)
* Heart failure
* Cognitive and motor disorders
* Orthopedic and neurological dysfunctions that may interfere with evaluation

Primary outcomes:
measure: The Incremental Shuttle Walk Test
timeFrame: Baseline
measure: Pedometer
timeFrame: The pedometer will be given to the participants on the day the participants are evaluated and it will be taken back after 7 days. At the end of 7 days, the total number of steps will be recorded.
measure: International Physical Activity Questionnaire-Short Form
timeFrame: Baseline
measure: Stop-Bang Test
timeFrame: Baseline
measure: Obese-Specific Quality of Life Scale
timeFrame: Baseline
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Hydraulic Hand Dynamometer
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References: