ObesityNCT06535295
Physical Activity, Functional Capacity and Quality of Life in Older Patients With Chronic Comorbidities
An observational study of Obesity and Hypertension, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of obesity, hypertension (HT) and type 2 diabetes (T2D) is increasing. The adoption of an increasingly sedentary lifestyle is one of the main factors contributing to the increased incidence of chronic diseases such as obesity, cardiovascular diseases, HT and T2D. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension, Type 2 Diabetes
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Thirty-seven patients with obesity Thirty-seven patients with hypertension Thirty-seven patients with type 2 diabetes Thirty-seven healthy older adults
Who may be able to join
- Being 65 years of age or older
- Body Mass Index (BMI) ≥30 kg/m²
- Being 65 years of age or older
- Being diagnosed with hypertension
- Regular use of antihypertensive medication
- Being 65 years of age or older
Show all 10Show fewer
- Being diagnosed with type 2 diabetes
- HbA1c levels: 57-78 mmol/mol (IFCC) or 7.4-9.3% (NGSP)
- Being 65 years of age or older
- Not having any chronic condition diagnosis
Who cannot join
- History of unstable angina or myocardial infarction
- Having a poor glycemic control
- Having a diabetic neuropathy
- Having a lower extremity musculoskeletal problem
- Having a balance disorder condition
- Having a cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kaguthane, 34408
About this study
Official title: Comparison of Physical Activity, Functional Capacity and Quality of Life Between Older Patients With Chronic Comorbidities and Healthy Peers
The prevalence of obesity, hypertension (HT) and type 2 diabetes (T2D) is increasing. The adoption of an increasingly sedentary lifestyle is one of the main factors contributing to the increased incidence of chronic diseases such as obesity, cardiovascular diseases, HT and T2D. Furthermore, lack of physical activity leads to a decline in functional capacity in these individuals, which facilitates the progression of HTN, T2D and obesity. The presence of multiple chronic comorbidities can exacerbate the negative impact on health-related quality of life. The main aim of this study was to compare the levels of physical activity, functional capacity and quality of life between elderly individuals with chronic comorbidities such as HTN, T2D and obesity and their healthy peers. Quality of life, functional capacity , and physical activity level will be assessed by SF-36 questionnaire, 6-minute walk test, and the International Physical Activity Questionnaire-short form, respectively.
Read the detailed description
Globally, the elderly population is increasing, along with a significant rise in the prevalence of chronic conditions such as obesity, hypertension (HT) and type 2 diabetes (T2D). The World Health Organization (WHO) reported in 2021 that over 2 billion adults were overweight, with more than 800 million classified as obese. At the same time, HT affected 1.28 billion adults globally, and the incidence of T2D surged from 108 million in 1980 to 537 million in 2021. Focusing on the older population, recent studies show that around 50% of older adults are affected by obesity, approximately 52.9% suffer from HT, and about 27.5% have T2D. The high prevalence of chronic diseases among older adults poses a significant health challenge and strains healthcare systems globally. This challenge is driven by increased life expectancy and the rapid aging of the population, which together lead to a larger elderly population and, consequently, a higher incidence of chronic diseases.
Obesity, T2D, and HT can lead to complications in the cardiovascular and musculoskeletal systems, which in turn are likely to negatively affect PA, functional capacity, and QoL. For instance, obesity can increase the load on joints due to excessive weight, thereby restricting mobility, while T2D may adversely affect walking capacity through peripheral neuropathy and vascular complications. Hypertension could exacerbate symptoms during PA by increasing the cardiovascular load. In managing chronic diseases such as obesity, HT, and T2D, medications play a vital role in controlling these conditions and preventing complications. Nevertheless, even with this treatment, patients may continue to experience declines in functional capacity, PA, and QoL. The impact of chronic diseases such as obesity, HT, and T2D on PA, functional capacity, and QoL in older adults remains unclear in the literature. Although early detection and prevention of these conditions are important, the specific effects on these health aspects are not well-defined. Research indicates that while these conditions can influence health, their impact varies among individuals, and effective management may mitigate some adverse effects. Further research is needed to clarify how chronic diseases such as obesity, HT, and T2D affect PA, functional capacity, and QoL in the older population, as there remains a significant gap in empirical data regarding these effects.
Therefore, the aim of our study is to compare PA, functional capacity, and QoL between patients with obesity, HT, T2D, and healthy controls, and to elucidate the differing impacts of these chronic conditions on these parameters. The physical activity level will be evaluated using the short form of the International Physical Activity Questionnaire (IPAQ), the functional capacity will be evaluated using the 6-minute walk test, and the quality of life will be evaluated using the SF-36 Quality of Life Scale. At the end of the study, physical activity, functional capacity and quality of life will be compared between older patients with chronic comorbidities and healthy peers.
- Conditions
- Obesity, Hypertension, Type 2 Diabetes
- Keywords
- Physical Activity, Functional Capacity, Quality of Life
- Medical subject headings
- Obesity, Hypertension, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity Group | Older patients with obesity | |
| Hypertension Group | Older patients with hypertension | |
| Type 2 Diabetes Group | Older patients with type 2 diabetes | |
| Healthy Group | Healthy older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Physical Activity
Physical activity will be assessed by SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: 10-15 minutes
Level of Functional Capacity
The 6-minute walking test will be used to assess the functional capacity. Participants will be recorded in a 30-meter straight corridor for 6 minutes at their own walking speed, as fast as possible but without running. The walking distance will be recorded in meters.
Measured: 15-20 minutes
Level of Quality of Life
Quality of life will be assessed by the International Physical Activity Questionnaire-short form. (IPAQ-SF). The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. If the participants reported at least 150 min/wk of walking, moderate, or vigorous intensity physical activity.
Measured: 8-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Ucgun, Biruni University
- Investigators
- Hikmet Ucgun, PT, PhD, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535295
- Sponsor's protocol ID
- auhucgun02
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Activity, Functional Capacity and Quality of Life Between Older Patients With Chronic Comorbidities and Healthy Peers
- ClinicalTrials.gov ID
- NCT06535295
- Acronym / sponsor ID
- auhucgun02
- Conditions
- Obesity, Hypertension, Type 2 Diabetes
- Keywords
- Physical Activity, Functional Capacity, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Aug 2024 (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.
The prevalence of obesity, hypertension (HT) and type 2 diabetes (T2D) is increasing. The adoption of an increasingly sedentary lifestyle is one of the main factors contributing to the increased incidence of chronic diseases such as obesity, cardiovascular diseases, HT and T2D. Furthermore, lack of physical activity leads to a decline in functional capacity in these individuals, which facilitates the progression of HTN, T2D and obesity. The presence of multiple chronic comorbidities can exacerbate the negative impact on health-related quality of life. The main aim of this study was to compare the levels of physical activity, functional capacity and quality of life between elderly individuals with chronic comorbidities such as HTN, T2D and obesity and their healthy peers. Quality of life, functional capacity , and physical activity level will be assessed by SF-36 questionnaire, 6-minute walk test, and the International Physical Activity Questionnaire-short form, respectively.
Detailed description
Globally, the elderly population is increasing, along with a significant rise in the prevalence of chronic conditions such as obesity, hypertension (HT) and type 2 diabetes (T2D). The World Health Organization (WHO) reported in 2021 that over 2 billion adults were overweight, with more than 800 million classified as obese. At the same time, HT affected 1.28 billion adults globally, and the incidence of T2D surged from 108 million in 1980 to 537 million in 2021. Focusing on the older population, recent studies show that around 50% of older adults are affected by obesity, approximately 52.9% suffer from HT, and about 27.5% have T2D. The high prevalence of chronic diseases among older adults poses a significant health challenge and strains healthcare systems globally. This challenge is driven by increased life expectancy and the rapid aging of the population, which together lead to a larger elderly population and, consequently, a higher incidence of chronic diseases.
Obesity, T2D, and HT can lead to complications in the cardiovascular and musculoskeletal systems, which in turn are likely to negatively affect PA, functional capacity, and QoL. For instance, obesity can increase the load on joints due to excessive weight, thereby restricting mobility, while T2D may adversely affect walking capacity through peripheral neuropathy and vascular complications. Hypertension could exacerbate symptoms during PA by increasing the cardiovascular load. In managing chronic diseases such as obesity, HT, and T2D, medications play a vital role in controlling these conditions and preventing complications. Nevertheless, even with this treatment, patients may continue to experience declines in functional capacity, PA, and QoL. The impact of chronic diseases such as obesity, HT, and T2D on PA, functional capacity, and QoL in older adults remains unclear in the literature. Although early detection and prevention of these conditions are important, the specific effects on these health aspects are not well-defined. Research indicates that while these conditions can influence health, their impact varies among individuals, and effective management may mitigate some adverse effects. Further research is needed to clarify how chronic diseases such as obesity, HT, and T2D affect PA, functional capacity, and QoL in the older population, as there remains a significant gap in empirical data regarding these effects.
Therefore, the aim of our study is to compare PA, functional capacity, and QoL between patients with obesity, HT, T2D, and healthy controls, and to elucidate the differing impacts of these chronic conditions on these parameters. The physical activity level will be evaluated using the short form of the International Physical Activity Questionnaire (IPAQ), the functional capacity will be evaluated using the 6-minute walk test, and the quality of life will be evaluated using the SF-36 Quality of Life Scale. At the end of the study, physical activity, functional capacity and quality of life will be compared between older patients with chronic comorbidities and healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obesity Group | – | –Older patients with obesity |
| Hypertension Group | – | –Older patients with hypertension |
| Type 2 Diabetes Group | – | –Older patients with type 2 diabetes |
| Healthy Group | – | –Healthy older adults |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Thirty-seven patients with obesity Thirty-seven patients with hypertension Thirty-seven patients with type 2 diabetes Thirty-seven healthy older adults
Key inclusion criteria (10 listed)
- Being 65 years of age or older
- Body Mass Index (BMI) ≥30 kg/m²
- Being 65 years of age or older
- Being diagnosed with hypertension
- Regular use of antihypertensive medication
Key exclusion criteria (6 listed)
- History of unstable angina or myocardial infarction
- Having a poor glycemic control
- Having a diabetic neuropathy
- Having a lower extremity musculoskeletal problem
- Having a balance disorder condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Physical Activity
Time frame: 10-15 minutes
Physical activity will be assessed by SF-36 questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Level of Functional Capacity
Time frame: 15-20 minutes
The 6-minute walking test will be used to assess the functional capacity. Participants will be recorded in a 30-meter straight corridor for 6 minutes at their own walking speed, as fast as possible but without running. The walking distance will be recorded in meters.
Level of Quality of Life
Time frame: 8-10 minutes
Quality of life will be assessed by the International Physical Activity Questionnaire-short form. (IPAQ-SF). The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. If the participants reported at least 150 min/wk of walking, moderate, or vigorous intensity physical activity.
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 2 Aug 2024.
- 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.
Hikmet Ucgun, PT, PhD principal investigator
Atlas University
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 and Hypertension, run by Biruni University 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 10 inclusion and 6 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 2 Aug 2024. 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?
Level of Physical Activity (time frame: 10-15 minutes). The study lists 3 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 2 Aug 2024.