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

NCT05088317 | Completed DMC

• 1 other identifier: 2021-31
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; exercise capacity; physical activity; sleep apnea; quality of life; anxiety; depression; hand grip strength

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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

• Stop-Bang Test

  The Stop-Bang Test is one of the screening tests used to evaluate the risk of obstructive sleep apnea.

  Baseline

• 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 Outcomes (2)

• Hospital Anxiety and Depression Scale

  Baseline

• Hydraulic Hand Dynamometer

  Baseline

Study Arms (2)

Obese group

Volunteer female and male individuals aged 20-65 years, followed in an Internal Diseases unit of a state hospital in Turkey, diagnosed with obesity (BMI\> 30 kg/m\^2), who met the inclusion criteria of the study.

Diagnostic Test: Exercise capacity

Healthy group

Healthy male and female individuals between the ages of 20-65 who were not diagnosed with obesity and volunteered to participate in the study.

Diagnostic Test: Exercise capacity

Interventions

Exercise capacity DIAGNOSTIC_TEST

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.

Healthy group; Obese group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goksen Kuran Aslan: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Sleep Apnea Syndromes; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Goksen Kuran Aslan

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 21, 2021
• Study Start: September 4, 2021
• Primary Completion: September 4, 2022
• Study Completion: December 4, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)