Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults

Obesity Clinical Trial

Official title:

The Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088317
• Other study ID #: 2021-31
• Status: Completed
• Start date: September 4, 2021
• Est. completion date: December 4, 2022

Study information

• Verified date: August 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 4, 2022
• Est. primary completion date: September 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• Exercise capacity
The incremental shuttle walking test at increasing speed (ISWT) is one of the field tests used to evaluate exercise capacity. It has been shown that ISWT is a valid and reliable assessment tool that can be used to evaluate exercise capacity in obese individuals. This test is an exercise test in which walking between two cones 10 m apart at increasing speed for 12 minutes is counted as one sit-up for each 10-meter walk between the two cones. It is continued until the patient is unable to continue the test due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or completes the 12-minute test. In this test, the primary measure is the distance walked, and the result is calculated based on the number of shuttles completed.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goksen Kuran Aslan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incremental Shuttle Walk Test	The incremental shuttle walking test at increasing speed is one of the field tests used to evaluate exercise capacity. This test is an exercise test in which walking between two cones 10 m apart at increasing speed for 12 minutes is counted as one sit-up for each 10-meter walk between the two cones. It is continued until the patient is unable to continue the test due to shortness of breath, the heart rate reaches 85% of the maximum expected heart rate, or completes the 12-minute test. In this test, the primary measure is the distance walked, and the result is calculated based on the number of shuttles completed.	Baseline
Primary	Pedometer	The pedometer is a cost-effective, easy-to-understand device that is usually worn on the waist with an apparatus, which allows to objectively evaluate the level of physical activity, measures the number of steps.	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.
Primary	International Physical Activity Questionnaire-Short Form	It is a questionnaire used to record the duration of physical activity at different levels in the last week.	Baseline
Primary	Stop-Bang Test	The Stop-Bang Test is one of the screening tests used to evaluate the risk of obstructive sleep apnea.	Baseline
Primary	Obese-Specific Quality of Life Scale	Obese-Specific Quality of Life Scale: The scale consists of 17 items and is a six-point Likert type. The scale is reverse scored and the total score is 102. When the total score approaches zero, it indicates that the quality of life of the individuals decreases, and when it approaches 100, the quality of life increases.	Baseline
Secondary	Hospital Anxiety and Depression Scale	7 items of the scale assess anxiety and 7 items assess depression. The answers, which are evaluated in a three-point Likert format, are scored between 0-3. When patients scored 0-10 for anxiety, patients were defined as no anxiety, 11 or more anxiety, and 0-7 points for depression as no depression, 8 or more depression.	Baseline
Secondary	Hydraulic Hand Dynamometer	Hydraulic Hand Dynamometer provides readings of grip strength.	Baseline