Morbid ObesityNCT04165811
Effects of Aerobic Dance Based Exercise Program After Surgery in Obeses Awating Bariatric Surgery
A study testing Exercise treatment and Counselling in people with Morbid Obesity and Bariatric Surgery Candidate, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Bariatric Surgery Candidate, Exercise
- What is being tested?
- Exercise treatment and Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2019to 30 Jun 2020
- 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
- Individuals aged between 18-65
- Body mass index ≥40 or ≥35 with concomitant diseases
- No surgical operation in the last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Dance Based Exercise Program on Lower Extremity Functions After Surgery in Obeses Awating Bariatric Surgery
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.
Read the 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.
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate, Exercise, Obesity
- Being tested
- Exercise treatment, Counselling
- Keywords
- bariatric surgey, morbid obesity, aerobic exercise, lower extremity functions
- Medical subject headings
- Obesity, Morbid, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise treatmentOther
Also called Aerobic dance based exercise
A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
CounsellingOther
Also called Counseling of physical activity
Only physical activity counseling will be given to the subjects in this group.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Dance based Exercise | Experimental | 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. Receives: Other: Exercise treatment |
| Counseling of physical activity | Experimental | Physical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period. Receives: Other: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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)
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Secondary outcomes (6)
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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 .
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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.
Measured: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start30 Nov 2019
- Primary completion30 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulfidan Tokgoz, Istanbul University - Cerrahpasa
- Investigators
- Gülfidan Tokgöz, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165811
- Sponsor's protocol ID
- IstanbulU-C
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2019
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Dance Based Exercise Program on Lower Extremity Functions After Surgery in Obeses Awating Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04165811
- Acronym / sponsor ID
- IstanbulU-C
- Conditions
- Morbid Obesity, Bariatric Surgery Candidate, Exercise, Obesity
- Keywords
- bariatric surgey, morbid obesity, aerobic exercise, lower extremity functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Nov 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aerobic Dance based Exercise | Experimental | Other: Exercise treatmentThe 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. |
| Counseling of physical activity | Experimental | Other: CounsellingPhysical activity counseling is aimed at increasing the physical activity levels of the individuals who are waiting for bariatric surgery in the preoperative period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged between 18-65
- Body mass index ≥40 or ≥35 with concomitant diseases
- No surgical operation in the last 6 months
Key exclusion criteria (6 listed)
- 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
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 treatmentAlso: Aerobic dance based exerciseA program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group. | Other | Aerobic Dance based Exercise |
| CounsellingAlso: Counseling of physical activityOnly physical activity counseling will be given to the subjects in this group. | Other | Counseling of physical activity |
Primary outcome
Six Minute Walk Test
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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)
6 secondary outcomes
Bioelectrical Impedance Analysis-obesity score
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Biodex Balance System-Fall Risk Test
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Evaluation of physical activity
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Sit and Up Test
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Stair Climbing Test
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite)
Time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months
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 11 May 2022.
- 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.
Gülfidan Tokgöz principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise treatment and Counselling in people with Morbid Obesity and Bariatric Surgery Candidate, run by Istanbul University - Cerrahpasa 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 3 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 11 May 2022. 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?
Six Minute Walk Test (time frame: Change from baseline to 8 weeks follow up at two months and post-op 5 months). The study lists 2 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 11 May 2022.