ObesityNCT05088317
Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
An observational study of Obesity, run by Goksen Kuran Aslan at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise capacity
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2021to 4 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Between the ages of 20-65
- With BMI>30 kg/m^2
- Between the ages of 20-65
- With BMI<30 kg/m^2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Exercise capacity
- Keywords
- obesity, exercise capacity, physical activity, sleep apnea, quality of life, anxiety, depression, hand grip strength
- Medical subject headings
- Obesity, Motor Activity, Sleep Apnea Syndromes, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise capacityDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Stop-Bang Test
The Stop-Bang Test is one of the screening tests used to evaluate the risk of obstructive sleep apnea.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
Hydraulic Hand Dynamometer
Hydraulic Hand Dynamometer provides readings of grip strength.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start4 Sep 2021
- Primary completion4 Sep 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goksen Kuran Aslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goksen Kuran Aslan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088317
- Sponsor's protocol ID
- 2021-31
- Status last verified
- Aug 2023
- First submitted
- 24 Sep 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Exercise Capacity With Physical Activity Level, Sleep Apnea Risk and Quality of Life in Obese Adults
- ClinicalTrials.gov ID
- NCT05088317
- Acronym / sponsor ID
- 2021-31
- Conditions
- Obesity
- Keywords
- obesity, exercise capacity, physical activity, sleep apnea, quality of life, anxiety, depression, hand grip strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Goksen Kuran AslanUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | – | Diagnostic Test: Exercise capacityVolunteer 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. |
| Healthy group | – | Diagnostic Test: Exercise capacityHealthy male and female individuals between the ages of 20-65 who were not diagnosed with obesity and volunteered to participate in the study. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Between the ages of 20-65
- With BMI>30 kg/m^2
- Between the ages of 20-65
- With BMI<30 kg/m^2
Key exclusion criteria (7 listed)
- Pregnancy
- Uncontrollable hypertension
- Uncontrolled diabetes requires the use of insulin
- Chronic lung diseases (COPD, etc.)
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise capacityThe 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. | Diagnostic test | Healthy group, Obese group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Baseline
Hydraulic Hand Dynamometer
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Goksen Kuran Aslan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incremental Shuttle Walk Test (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.