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ObesityNCT06318741

Effects of Aerobic Exercise in Obese Patients with Atherosclerotic Cardiovascular Disease

A study testing aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints. and Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints. in people with Obesity and Coronary Artery Disease, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Coronary Artery Disease
What is being tested?
aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints. and Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2024to Dec 2024
Phase
Interventional
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Class 1 and class 2 obese patients with a BMI of 30 kg/m2 and above and below 40 kg/m2
  • Patients with atherosclerotic cardiovascular disease diagnosed by angiography
  • Women and men aged 18-65
  • Individuals who agree to participate in the study and have received a written voluntary consent form.

Who cannot join

  • Clinical neuromuscular diseases that limit exercise, previous diagnosis of asthma, congestive heart failure, unstable angina, uncontrolled psychiatric disease or cognitive-cognitive disorders (confirmed and diagnosed in International Classification of Disease (ICD)-10 diagnosis codes 'Schizophrenia and Psychotic states (F20, F20.0, F20.1, F20.2, F20.3, F20.4, F20.5, F20.6, F20.8, F20.9, F06.2, F23.0, F23.1, F23.2, F29) , Bipolar Disorder (F31, F31.0, F31.1, F31.2, F31.3, F31.4, F31.5, F31.6, F31.7, F31.8, F31.9) and Substance Abuse (Patients with diagnosis code ' (Z86.4)')
  • Presence of uncontrolled systemic diseases
  • Uncontrolled hypertension,
  • Uncontrolled diabetes mellitus,
  • Chronic liver failure
  • Chronic renal failure and dialysis patients
Show all 28Show fewer
  • Chronic obstructive pulmonary disease and asthma
  • Malignancy
  • Infection
  • High fever
  • Acute inflammatory rheumatic diseases
  • Acute peripheral vascular diseases
  • Smoking before exercise test
  • Alcohol consumption before exercise test
  • Use of medications known to affect physical performance, heart rate or metabolism (including Beta blockers)
  • Patients without cooperation and compliance
  • Patients who did not agree to participate in the study
  • Patients who have been included in the cardiopulmonary rehabilitation (CPR) program in the last year
  • With acute coronary syndrome
  • Troponin positive
  • Unstable angina pectoris
  • Basic contraindications of exercise test:
  • High risk unstable angina
  • Acute Cardiac Diseases (Acute MI, Acute endocarditis, myocarditis or pericarditis, Acute pulmonary embolism, etc.)
  • Uncontrolled arrhythmias that can disrupt the hemodynamic response
  • Symptomatic severe aortic stenosis
  • Decompensated heart failure
  • Non-cardiac pathologies that will affect exercise performance and be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis).

Trial locations and contacts

1 site in 1 country.

Havva Talay Çalış, Prof contact

03523157700 ext. 61244

htalaycalis@yahoo.com

Selim Oğuz, MD contact

05062227012

mdselimoguz@gmail.com

Turkey (Türkiye)1 site
  • Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

    Kayseri, 38080

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Aerobic Exercise on Kinesiophobia, Functional Capacity and Quality of Life in Obese Patients with Atherosclerotic Cardiovascular Disease

Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus, so obesity treatment should be managed multidisciplinary. The basic approach to obesity treatment is diet, exercise, medical treatment, treatment of comorbid conditions and surgery. Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury.

Read the detailed description

Obesity, defined by the World Health Organization (WHO) as "abnormal or excessive fat accumulation in the body that negatively affects health", has become an important public health problem that affects the quality of life at individual and social levels. Obesity is defined by using body mass index (BMI) (BMI ≥ 25 patients are classified as overweight, BMI ≥30 as obese, BMI ≥40 as morbidly obese. Obese patients are classified according to BMI as Class 1, BMI: 30-34.9 and Class 2, BMI: 35-39.9. Class 1 and 2 patients were included in the study. Patients will be included. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus and chronic musculoskeletal disorders such as osteoarthritis, low back pain and fibromyalgia. Therefore, obesity treatment should be managed multidisciplinary. The basic approach in obesity treatment is diet. , exercise, medical treatment, treatment of comorbid conditions and surgery.Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Anthropometry is the investigation of measurements of the human body in terms of bone dimensions, muscle and fat tissue. Anthropometric measurements are measurements that reveal the composition and body size / structure of the human body. Anthropometric measurements gain importance when evaluating the nutritional status of people because they show body fat storage and protein storage. Evaluation of growth and body composition, that is, body fat and lean body tissue, can be determined by anthropometric measurements. Anthropometric measurements help analyze the relationship between obesity and diseases. Anthropometric measurements are important for evaluating the nutritional status of a population or individual. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury. Kinesiophobia is assessed with the Tampa Kinesiophobia Scale. This scale, consisting of 17 items, evaluates how afraid patients are of moving their bodies. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. Each item is scored on a 4-point Likert Scale; 1-4. The answers and their numerical values are as follows: 1; Strongly disagree, 2; disagree, 3; agree and 4; I totally agree. The scores of items 4, 8, 12 and 16 should be reversed when calculating the total score. The total score obtained by adding different items may vary between 17 and 68. Previous studies have shown that this scale is generally applied to patients with low back pain, knee osteoarthritis, lymphedema and osteoporosis. In the literature, there are limited age group and uncontrolled studies in patients with cardiovascular disease. However, to the best of this knowledge, this study will be one of the limited number of blind, prospective, randomized controlled studies in the literature that evaluate fear of movement in obese patients with atherosclerotic cardiovascular disease who receive aerobic exercise therapy. The aim of this study is to investigate the effects of an aerobic exercise program on anthropometric measurements, kinesiophobia, psychosocial status, physical activity level and quality of life in obese individuals with atherosclerotic cardiovascular disease. This hypothesis in this study is that an aerobic exercise program will cause significant changes in anthropometric measures, kinesiophobia and quality of life in obese patients with atherosclerotic heart disease. In this study, it is expected that a regular, supervised aerobic exercise program will create a more effective response in terms of physical, psychosocial and patient compliance in the individual compared to a home exercise program in obese individuals who often have a sedentary lifestyle, and therefore will provide a change in anthropometric measurements. Patients who are admitted to Kayseri City Hospital Physical Medicine and Rehabilitation Clinic Cardiopulmonary Rehabilitation Unit, between the ages of 18-65, with a BMI of 30-40, with class 1 and 2 obese atherosclerotic cardiovascular pathology, and with American Heart Association stage B and New York Heart Association class 1 will be included in this study. Patients participating in the study will be randomized into 2 groups: moderate-intensity continuous exercise group (Group 1) and home exercise group (Group 2). The change in the average Tampa Scale Kinesiophobia (TSK) score of each group over time will be evaluated within the 0th, 8th and 20th weeks. Additionally, the change in the average TSK scores between the two groups over time (0th, 8th and 20th weeks) will be compared. In this hypothesis; A decrease in TSK score is expected over time with the exercise program. The minimum sample size required to find a significant difference between both groups was determined by Jiménez et al. It was calculated in the G*Power 3.1.9.4 program, using the study as a reference. According to these criteria; While the power of the test (1-β) is 0.80, the amount of type-1 error (α) is 0.05, and the alternative hypothesis (H1) is one-sided, the minimum sample size required to find a significant difference between the groups is a total of 28 patients, 14 patients in each group. calculated as a patient. The dropout rate was estimated to be 10%. Therefore, a total of 32 patients will be included in the study, 16 patients in both groups.

Being tested
aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints., Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.
Medical subject headings
Obesity, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints.Other

    aerobic exercise on the treadmill

  • Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.Other

    Walking at an intensity of 12-13 RPE

Study groups in NCT06318741
Study groupRoleWhat they receive
hospital exercise groupActive comparatorAccording to the Cardiopulmonary exercise test (KPET) test in Group 1 (medium intensity continuous exercise group), 50 minutes (5 minutes warm-up, 40 minutes exercise, 5 minutes exercise, 5 minutes warm-up, 40 minutes exercise, 5 minutes) for 8 weeks, 3 days a week, at an exercise intensity of 50-60% of the VO2 max level recorded individually in the patients. Aerobic exercise therapy will be organized to be applied on a treadmill (in the form of a minute cool-down).
Receives: Other: aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints.
home exercise groupPlacebo comparatorFor the home exercise group, walking for 50 minutes, 3 days a week, with an intensity of 12-13 Rate of perceived exertion (RPE) according to the Modified Borg scale will be recommended for 8 weeks.
Receives: Other: Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tampa Kinesiophobia Scale

    Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury. This scale, consisting of 17 items, evaluates how afraid patients are of moving their bodies. A high score indicates a high level of fear of movement, while a low score indicates a negligible level of fear of movement. Each item is scored on a 4-point Likert Scale.

    Measured: week 0, 8th week, 20th week

Secondary outcomes (7)
  1. Cardiopulmonary exercise test

    Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system.

    Measured: week 0, 8th week, 20th week

  2. 6 Minutes Walking Test

    It is a frequently used test in cardiopulmonary rehabilitation to monitor exercise capacity and treatment effectiveness. The patient should rest by sitting in a chair for 15 minutes before the test and wear appropriate shoes and comfortable clothing. Calculate the distance walked by the patient at their own walking pace in 6 minutes, preferably in a 30-meter long corridor.

    Measured: week 0, 8th week, 20th week

  3. Body anthropometric measurements

    Waist circumference, hip circumference, waist/hip ratio, waist/height ratio.

    Measured: week 0, 8th week, 20th week

  4. Hospital anxiety and depression scale

    The Hospital Anxiety and Depression (HADS) Scale was prepared to screen for anxiety and depression in people with physical illnesses.

    Measured: week 0, 8th week, 20th week

  5. international physical activity score

    It is a survey consisting of 7 questions that patients will answer and provides information about the time spent in sitting, walking, moderate and vigorous activities. The total score is obtained by calculating the time (minutes) and weekly frequencies (days) spent in these activities.

    Measured: week 0, 8th week, 20th week

  6. MacNew Heart Disease Health-Related Quality of Life Survey

    It is designed to assess the patient's feelings about how ischemic heart disease affects daily functioning and includes 27 items, a global HRQoL score and physical limitation, emotional, and social function subscales, along with a summary of available international results.

    Measured: week 0, 8th week, 20th week

  7. Numerical Rating Scale

    It is used as a measure of pain intensity in adults. 0;no pain, 10; It is the strongest pain felt

    Measured: week 0, 8th week, 20th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06318741
Sponsor's protocol ID
KayseriCHkinezyofobi
Status last verified
Sep 2024
First submitted
13 Mar 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Apovian CM. Obesity: definition, comorbidities, causes, and burden. Am J Manag Care. 2016 Jun;22(7 Suppl):s176-85.

    PubMed 27356115
  • Jackson VM, Breen DM, Fortin JP, Liou A, Kuzmiski JB, Loomis AK, Rives ML, Shah B, Carpino PA. Latest approaches for the treatment of obesity. Expert Opin Drug Discov. 2015;10(8):825-39. doi: 10.1517/17460441.2015.1044966. Epub 2015 May 12.

    PubMed 25967138
  • Libby P, Theroux P. Pathophysiology of coronary artery disease. Circulation. 2005 Jun 28;111(25):3481-8. doi: 10.1161/CIRCULATIONAHA.105.537878.

    PubMed 15983262
  • Wood DW, Haig AJ, Yamakawa KS. Fear of movement/(re)injury and activity avoidance in persons with neurogenic versus vascular claudication. Spine J. 2012 Apr;12(4):292-300. doi: 10.1016/j.spinee.2012.02.015. Epub 2012 Apr 4.

    PubMed 22480530
  • Gazarova M, Galsneiderova M, Meciarova L. Obesity diagnosis and mortality risk based on a body shape index (ABSI) and other indices and anthropometric parameters in university students. Rocz Panstw Zakl Hig. 2019;70(3):267-275. doi: 10.32394/rpzh.2019.0077.

    PubMed 31515986
  • Luque-Suarez A, Martinez-Calderon J, Falla D. Role of kinesiophobia on pain, disability and quality of life in people suffering from chronic musculoskeletal pain: a systematic review. Br J Sports Med. 2019 May;53(9):554-559. doi: 10.1136/bjsports-2017-098673. Epub 2018 Apr 17.

    PubMed 29666064
  • Weermeijer JD, Meulders A. Clinimetrics: Tampa Scale for Kinesiophobia. J Physiother. 2018 Apr;64(2):126. doi: 10.1016/j.jphys.2018.01.001. Epub 2018 Mar 19. No abstract available.

    PubMed 29567379
  • Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.

    PubMed 29651872
  • Areeudomwong P, Buttagat V. Reliability and Validity of the Cross-Culturally Adapted Thai Version of the Tampa Scale for Kinesiophobia in Knee Osteoarthritis Patients. Malays J Med Sci. 2017 Mar;24(2):61-67. doi: 10.21315/mjms2017.24.2.8. Epub 2017 Apr 14.

    PubMed 28894405
  • Gencay Can A, Can SS, Eksioglu E, Cakci FA. Is kinesiophobia associated with lymphedema, upper extremity function, and psychological morbidity in breast cancer survivors? Turk J Phys Med Rehabil. 2018 Aug 12;65(2):139-146. doi: 10.5606/tftrd.2019.2585. eCollection 2019 Jun.

    PubMed 31453554
  • Gunendi Z, Eker D, Tecer D, Karaoglan B, Ozyemisci-Taskiran O. Is the word "osteoporosis" a reason for kinesiophobia? Eur J Phys Rehabil Med. 2018 Oct;54(5):671-675. doi: 10.23736/S1973-9087.18.04931-6. Epub 2018 Feb 7.

    PubMed 29422485
  • Adachi H. Cardiopulmonary Exercise Test. Int Heart J. 2017 Oct 21;58(5):654-665. doi: 10.1536/ihj.17-264. Epub 2017 Sep 30.

    PubMed 28966333
  • Hamilton DM, Haennel RG. Validity and reliability of the 6-minute walk test in a cardiac rehabilitation population. J Cardiopulm Rehabil. 2000 May-Jun;20(3):156-64. doi: 10.1097/00008483-200005000-00003.

    PubMed 10860197
  • Sakamoto M, Suematsu Y, Yano Y, Kaino K, Teshima R, Matsuda T, Fujita M, Tazawa R, Fujimi K, Miura SI. Depression and Anxiety Are Associated with Physical Performance in Patients Undergoing Cardiac Rehabilitation: A Retrospective Observational Study. J Cardiovasc Dev Dis. 2022 Jan 11;9(1):21. doi: 10.3390/jcdd9010021.

    PubMed 35050231
  • Wang Y, Cao J, Kong X, Wang S, Meng L, Wang Y. The effects of CPET-guided cardiac rehabilitation on the cardiopulmonary function, the exercise endurance, and the NT-proBNP and hscTnT levels in CHF patients. Am J Transl Res. 2021 Jun 15;13(6):7104-7114. eCollection 2021.

    PubMed 34306470

Questions about this trial

What is this clinical trial studying?

A study testing aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints. and Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints. in people with Obesity and Coronary Artery Disease, run by Kayseri City Hospital 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 28 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: status not confirmed, as of the sponsor's last update on 19 Sep 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Havva Talay Çalış, Prof (03523157700 ext. 61244, htalaycalis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tampa Kinesiophobia Scale (time frame: week 0, 8th week, 20th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06318741, which also lists 17 linked publications.

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 19 Sep 2024.

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