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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04165811
Other study ID # IstanbulU-C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2019
Est. completion date June 30, 2020

Study information

Verified date August 2020
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, our primary aim is; investigate the effect of aerobic dance based exercise program on lower extremity functions (walking, stair stroke climbing, etc.) in obese individuals awaiting bariatric surgery.


Description:

In this study, our primary aim is; investigate the effect of aerobic dance based exercise program on lower extremity functions (walking, stair stroke climbing, etc.) in obese individuals awaiting bariatric surgery. . Our secondary aim is to provide the individual with exercise habits and increase the level of physical activity in daily life with the exercise program planned according to the needs of the individual.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals aged between 18-65 - Body mass index =40 or =35 with concomitant diseases - No surgical operation in the last 6 months Exclusion Criteria: - Musculoskeletal disorders or systemic diseases that may prevent exercise - The presence of psychiatric or neurological disease affecting cooperation and cognitive functions - Presence of acute pain - Heart pain - Presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension - Regular exercise for 6 months

Study Design


Intervention

Other:
Exercise treatment
A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
Counselling
Only physical activity counseling will be given to the subjects in this group.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six Minute Walk Test The Six Minute Walk Test was conducted according to a standardized protocol, using an internal hallway with the 30-meter distance marked by colored tape on the floor. Participants will be told that "the purpose of this test is to see how far you can walk in six minutes." Then, they will be instructed to "walk from end to end of the hallway at your own pace, in order to cover as much ground as possible." Participants will be allowed to stop and rest during the test, but will be instructed to resume walking as soon as they were able to do so. Before the walk started and at the end of the 6-min walk, participants will be shown a modified Borg dyspnea scale printed on a card and asked to "indicate your current degree of shortness of breath" on a scale of "0 = nothing at all" to "10 = very, very severe." At the end of the walk, they will be asked if they had experienced any of the following specific symptoms: dyspnea, chest pain, light-headedness, or leg pain, or any other symptoms. Change from baseline to 8 weeks follow up at two months and post-op 5 months
Primary Biodex Isokinetic Muscle Strength Measurement sokinetic device. In all cases; In accordance with the test measurement protocol, both the Quadriceps Femoris and the Hamstring muscle strength were concentric contraction, primarily 5 repetitions at 60 ° / sec; then 10 repetitions at a rate of 240° / sec. After each limb measurement, a rest interval of 2 minutes will be given. Peak torque will be recorded in Newtonmeters / kilograms (Nm / kg) Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Bioelectrical Impedance Analysis-obesity score Body components such as body fat percentage, body fat amount, lean body percentage, lean body mass, body water percentage, body water quantity, body mass index are calculated with bioelectrical impedance analysis. The muscle, fat and water ratio of the cases will be evaluated with Tanita Bioelectric Impedance Device. When the device assess the body fat percentage, body fat amount, lean body percentage, lean body mass, body water percentage, body water quantity and body mass index, it offers to us a score as called obesity score. Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Biodex Balance System-Fall Risk Test Biodex Balance System is a system that offers the possibility of evaluating the balance statically and dynamically. It is a system that measures the displacements in the center of gravity of a patient standing on an outpatient balance platform and the reactions of the support surface when the surface changes. For the static balance will be assessed with "Fall Risk Test " by using Biodex Balance system. Fall risk test offers to us a total score. Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Evaluation of physical activity The physical activity level of the cases will be evaluated with the International Physical Activity Questionnaire. In the questionnaire, the time spent by individuals in the last 7 days is questioned by considering the types of physical activity they perform in their daily lives. Met value of each activity is calculated to determine how active an individual is. Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Sit and Up Test The participant seated in a standard chair with a height of 43 cm with his arms crossed on his shoulders is asked to stand up and sit quickly for 30 seconds and the number of repetitions in which complete departure is achieved is recorded . Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Stair Climbing Test In the literature, it is seen that ladder up and down activity is evaluated by several different methods. One of the most commonly used methods is the ladder up and down test. The test person stops at the beginning of the ladder, after the order is given, the ladder starts to climb as fast as possible, and ends with the stopping of both feet at the beginning and the elapsed time is measured and recorded with a stopwatch. These measured values are used to evaluate the performance of a person going up and down stairs. Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite) The IWQOL (Weight Effect on Quality of Life Questionnaire) questionnaire is the first instrument intended to evaluate the quality of life specifically for obesity. It has been developed in the clinical setting for moderate to severe obesity and measures the quality of life aspects identified by obese people as the most important concerns in treatment. In the clinical evaluation of quality of life, when the necessity of short and obesity-specific tools is met, a more reduced form of the questionnaire, IWQOL-Lite, was developed. Change from baseline to 8 weeks follow up at two months and post-op 5 months
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