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

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ClinicalTrials.gov Identifier: NCT05088317
Recruitment Status : Enrolling by invitation
First Posted : October 21, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Goksen Kuran Aslan, Istanbul University

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.

Condition or disease Intervention/treatment
Obesity Diagnostic Test: Exercise capacity

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.

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Other
Time Perspective: Other
Official Title: The Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
Actual Study Start Date : September 4, 2021
Estimated Primary Completion Date : September 4, 2022
Estimated Study Completion Date : December 4, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
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
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.




Primary Outcome Measures :
  1. The Incremental Shuttle Walk Test [ Time Frame: Baseline ]
    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.

  2. Pedometer [ Time Frame: 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. ]
    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.

  3. International Physical Activity Questionnaire-Short Form [ Time Frame: Baseline ]
    It is a questionnaire used to record the duration of physical activity at different levels in the last week.

  4. Stop-Bang Test [ Time Frame: Baseline ]
    The Stop-Bang Test is one of the screening tests used to evaluate the risk of obstructive sleep apnea.

  5. Obese-Specific Quality of Life Scale [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: Baseline ]
    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.

  2. Hydraulic Hand Dynamometer [ Time Frame: Baseline ]
    Hydraulic Hand Dynamometer provides readings of grip strength.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088317


Locations
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Turkey
Istanbul University-Cerrahpasa
Istanbul, Turkey
Sponsors and Collaborators
Goksen Kuran Aslan
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Responsible Party: Goksen Kuran Aslan, Assoc. Prof. Goksen Kuran Aslan, Istanbul University
ClinicalTrials.gov Identifier: NCT05088317    
Other Study ID Numbers: 2021-31
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Goksen Kuran Aslan, Istanbul University:
obesity
exercise capacity
physical activity
sleep apnea
quality of life
anxiety
depression
hand grip strength
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases