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Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery

Primary Purpose

Morbid Obesity, Bariatric Surgery Candidate, Exercise

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise treatment
Counselling
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring bariatric surgey, morbid obesity, aerobic exercise, lower extremity functions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobic Dance based Exercise

Counseling of physical activity

Arm Description

The exercise program will be administered 60 minutes, 2 days a week for 8 weeks. The exercise program will be created by physiotherapists as a group exercise program.

Physical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period.

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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.
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.
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.
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 .
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.
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.

Full Information

First Posted
November 14, 2019
Last Updated
May 10, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04165811
Brief Title
Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery
Official Title
Effects of Aerobic Dance Based Exercise Program on Lower Extremity Functions After Surgery in Obeses Awating Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery Candidate, Exercise, Obesity
Keywords
bariatric surgey, morbid obesity, aerobic exercise, lower extremity functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Dance based Exercise
Arm Type
Experimental
Arm Description
The exercise program will be administered 60 minutes, 2 days a week for 8 weeks. The exercise program will be created by physiotherapists as a group exercise program.
Arm Title
Counseling of physical activity
Arm Type
Experimental
Arm Description
Physical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period.
Intervention Type
Other
Intervention Name(s)
Exercise treatment
Other Intervention Name(s)
Aerobic dance based exercise
Intervention Description
A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
Intervention Type
Other
Intervention Name(s)
Counselling
Other Intervention Name(s)
Counseling of physical activity
Intervention Description
Only physical activity counseling will be given to the subjects in this group.
Primary Outcome Measure Information:
Title
Six Minute Walk Test
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Biodex Isokinetic Muscle Strength Measurement
Description
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)
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary Outcome Measure Information:
Title
Bioelectrical Impedance Analysis-obesity score
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Biodex Balance System-Fall Risk Test
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Evaluation of physical activity
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Sit and Up Test
Description
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 .
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Stair Climbing Test
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months
Title
Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite)
Description
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.
Time Frame
Change from baseline to 8 weeks follow up at two months and post-op 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülfidan Tokgöz
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery

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