Bariatric SurgeryNCT05454696
Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery
A study testing Exercise and online physical activity counselling in people with Bariatric Surgery and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Obesity is defined as abnormal or excessive fat accumulation that can impair health. Obesity is considered a risk factor for diseases such as hypertension, heart failure, coronary heart diseases, diabetes mellitus, sleep apnea, and osteoarthritis. The prevalence of obesity is increasing all over the world. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery, Obesity, Exercise
- What is being tested?
- Exercise and online physical activity counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2022to 1 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 18 and 60
- Patients who volunteer
- Patients who can use technological devices at a level to participate in the online treatment
- Patients who completed a minimum of 8 weeks and a maximum of 2 years after surgery
Who cannot join
- Patients who are pregnant
- Patients who have psychiatric or psychological disorders that may affect adherence to treatment
- Patients who have an orthopaedic, neurological, cardiac, pulmonary or metabolic condition that may prevent participation and continuation of the exercise program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34320
About this study
Official title: Effects of Online Clinic Pilates Exercises on Functionality and Physical Fitness in Patients Undergoing Bariatric Surgery
Obesity is defined as abnormal or excessive fat accumulation that can impair health. Obesity is considered a risk factor for diseases such as hypertension, heart failure, coronary heart diseases, diabetes mellitus, sleep apnea, and osteoarthritis. The prevalence of obesity is increasing all over the world. Therefore, it is very important to decide on the most appropriate treatment therapy method for the treatment of obesity. Bariatric surgery has become an accepted method in the treatment of obesity in recent years. It is the most effective and efficient treatment method in the long term for individuals with severe obesity. Exercise therapy is recommended by literature to maintain weight loss, prevent weight regain and minimize complications after bariatric surgery. However, there is no consensus on the appropriate exercise program. There is heterogeneity in the type, intensity and duration of exercise. In addition, the effect of clinical pilates exercises in the post-bariatric period has not been examined. Moreover, there is no study conducted in the post-bariatric period with telerehabilitation, which has been very popular in recent years. This study aims to reveal the effect of clinical pilates exercises on the functionality and physical fitness of post-bariatric patients. The results of our study will also contribute to the literature by revealing the effect of telerehabilitation on these patients.
Read the detailed description
Patients who have undergone bariatric surgery and are followed in the Department of Endocrinology and Metabolism of Istanbul University Faculty of Medicine will be included in this study. Pre-treatment evaluation of the participants will be made and then individuals will be divided into two groups as Exercise Group (EG) and Control Group (CG) with a computer-assisted randomization program. The study will be conducted in accordance with the Declaration of Helsinki and a consent form will be obtained from the patients. Before the study, the purpose of the study will be explained and detailed information will be provided to the patients. CG will receive online physical activity counselling by a physiotherapist only once. EG will do online clinical pilates exercises under the supervision of a physiotherapist. The exercise program will last for 1 hour with a warm-up and cool-down period and the program will be continued twice a week for a total of 6 weeks. At the end of the treatment, individuals will be evaluated again. The primary aim is to examine the effect of online clinical pilates exercises on functionality and physical fitness in patients undergoing bariatric surgery. The secondary aim is to examine the effectiveness of telerehabilitation program after bariatric surgery.
- Conditions
- Bariatric Surgery, Obesity, Exercise, Physical Activity
- Being tested
- Exercise, online physical activity counselling
- Keywords
- Physical Fitness, Exercise, Pilates, Quality of Life
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Patients in the exercise group will participate in online clinical pilates exercise sessions under the supervision of a physiotherapist twice a week. The exercises will be done via the Zoom application and will continue for 6 weeks. The exercise program will last one hour with a warm-up and cool-down period. The exercises will be done by adhering to the basic principles of clinical pilates. The exercise program includes mat exercises that provide general body strengthening and stretching. Progression will be provided according to the health status of the patients and their compliance with exercise. The intensity of exercise will be planned as medium according to the Rating of perceived exertion (RPE) Scale.
online physical activity counsellingOther
CG will receive online physical activity counselling by a physiotherapist only once. The importance of physical activity after surgery and the points to be considered during physical activity will be explained to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | The exercise group will follow the online clinical mat pilates exercises (via Zoom application) accompanied by a physiotherapist. Receives: Other: Exercise |
| Control Group | Active comparator | The control group will receive online (via Zoom application) physical activity counselling by the physiotherapist only once. Receives: Other: online physical activity counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Senior Fitness Test
The Senior Fitness Test Battery is used to evaluate the functional status of the participants. This battery consisted of 6 different tests that assess cardiorespiratory fitness, muscle strength, endurance and flexibility. Although it is a test that is developed to assess the functional evaluation of elderly individuals, it is used for functional evaluation of cases with fibromyalgia and obesity.
Measured: 6 weeks
Six-Minute Walk Test (6 MWT)
The 6 MWT is used to evaluate the aerobic endurance of the patients. 6 MWT will be done according to American Thoracic Society (ATS) criteria. This test requires patients to walk at their own walking pace, as fast as possible but without running, for 6 minutes on a 30-metre straight corridor and the distance covered in meters will be recorded. In addition, before and after saturation, heart rate, dyspnea and fatigue levels will be evaluated by pulse oximetry. Modified Borg Dyspnea and Fatigue Scales will be used to determine dyspnea and fatigue levels.
Measured: 6 weeks
The Chair Stand Test
This test is used to assess lower extremity strength and function. This requires participants to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands will be recorded.
Measured: 6 weeks
The Biceps Curl Test
This requires participants to repeatedly lift a 5 lb (2.27 kg) weight (for women) or an 8 lb (3.63 kg) weight (for men) for 30 seconds. The number of lifts will be recorded. This reflects upper body strength.
Measured: 6 weeks
The Chair Sit and Reach Test
For the test, the individual is asked to reach towards the toes with both hands in a sitting position with one knee flexed, the other knee extended and the ankle flexed to 90 degrees. The distance between the tip of the finger and the tip of the toe is recorded in cm. The test is repeated three times, the best distance is recorded, and the test is repeated for both limbs. This reflects lower body flexibility.
Measured: 6 weeks
The Back Scratch Test
One hand is extended over the shoulder and the other is extended up the middle of the back and the approach distance of the middle fingers is measured and recorded in centimetres (cm). The test is repeated three times, the best distance is recorded, and the test is repeated for both limbs. This reflects upper body flexibility.
Measured: 6 weeks
8-Foot Up and Go Test
This test requires the patient to get up from the chair as quickly as possible, take 8 steps and sit back in the chair. The time that's spent is measured and recorded in seconds.
Measured: 6 weeks
Secondary outcomes (8)
Muscle Strength
A digital dynamometer is used to evaluate muscle strength. Muscle strength is recorded in Newtons (N). Each measurement is repeated three times for the right and left extremities and the average recorded.
Measured: 6 weeks
Core Stabilization
Core stability is evaluated with the Pressure Biofeedback Unit in accordance with the Sahrmann Core Stability Test protocol. The cuff is placed on the natural lordotic curve and inflated to 40 mmHg while the patient is lying supine. The test consists of 5 levels, while different lower extremity movements are performed at each level, core stabilization is expected to be preserved. After the patient completes a level successfully, other levels are tried.
Measured: 6 weeks
Obesity and Weight Loss Quality Of Life (OWLQOL)
The Obesity and Weight Loss Quality of Life Scale, developed by Patrick et al., is used to assess the health-related quality of life of patients. The scale is single-factor and has no sub-groups. The scale consists of 17 items and each item is scored between 0-6. A single quality of life score is obtained by summing all of the items. The higher score is related to high quality of life.
Measured: 6 weeks
Nottingham Health Profile
The Nottingham Health Profile (NHP) is a general patient-reported outcome measure which seeks to measure subjective health status. It is a questionnaire designed to measure a patient's view of their own health status in several areas. The NHP is consisted of two parts; the first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. The second part of the NHP is optional and can be omitted without ruining the test results.
Measured: 6 weeks
Body Fat Percentage
The body fat percentage (BFP) of a patient is the total mass of fat divided by total body mass, multiplied by 100; body fat includes essential body fat and storage body fat. The body fat percentage of the patients will be evaluated with the bioelectrical impedance analysis technique. Results will be recorded in percent.
Measured: 6 weeks
Muscle Mass
Muscle mass means the amount of soft muscle tissue in the body. The muscle mass of the patients will be evaluated with the bioelectrical impedance analysis technique. Results will be recorded in kg.
Measured: 6 weeks
Body Mass Index (BMI)
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Measured: 6 weeks
Bone Mass
Bone mass means the amount of bone tissue in the skeleton. The bone mass of the patients will be evaluated with the bioelectrical impedance analysis technique. Results will be recorded in kg.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start19 Sep 2022
- Primary completion1 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454696
- Sponsor's protocol ID
- 2022/GAslan
- Status last verified
- Mar 2024
- First submitted
- 1 Jul 2022
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Online Clinic Pilates Exercises on Functionality and Physical Fitness in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05454696
- Acronym / sponsor ID
- 2022/GAslan
- Conditions
- Bariatric Surgery, Obesity, Exercise, Physical Activity
- Keywords
- Physical Fitness, Exercise, Pilates, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 12 Jul 2022 (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.
Obesity is defined as abnormal or excessive fat accumulation that can impair health. Obesity is considered a risk factor for diseases such as hypertension, heart failure, coronary heart diseases, diabetes mellitus, sleep apnea, and osteoarthritis. The prevalence of obesity is increasing all over the world. Therefore, it is very important to decide on the most appropriate treatment therapy method for the treatment of obesity. Bariatric surgery has become an accepted method in the treatment of obesity in recent years. It is the most effective and efficient treatment method in the long term for individuals with severe obesity. Exercise therapy is recommended by literature to maintain weight loss, prevent weight regain and minimize complications after bariatric surgery. However, there is no consensus on the appropriate exercise program. There is heterogeneity in the type, intensity and duration of exercise. In addition, the effect of clinical pilates exercises in the post-bariatric period has not been examined. Moreover, there is no study conducted in the post-bariatric period with telerehabilitation, which has been very popular in recent years. This study aims to reveal the effect of clinical pilates exercises on the functionality and physical fitness of post-bariatric patients. The results of our study will also contribute to the literature by revealing the effect of telerehabilitation on these patients.
Detailed description
Patients who have undergone bariatric surgery and are followed in the Department of Endocrinology and Metabolism of Istanbul University Faculty of Medicine will be included in this study. Pre-treatment evaluation of the participants will be made and then individuals will be divided into two groups as Exercise Group (EG) and Control Group (CG) with a computer-assisted randomization program. The study will be conducted in accordance with the Declaration of Helsinki and a consent form will be obtained from the patients. Before the study, the purpose of the study will be explained and detailed information will be provided to the patients. CG will receive online physical activity counselling by a physiotherapist only once. EG will do online clinical pilates exercises under the supervision of a physiotherapist. The exercise program will last for 1 hour with a warm-up and cool-down period and the program will be continued twice a week for a total of 6 weeks. At the end of the treatment, individuals will be evaluated again. The primary aim is to examine the effect of online clinical pilates exercises on functionality and physical fitness in patients undergoing bariatric surgery. The secondary aim is to examine the effectiveness of telerehabilitation program after bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseThe exercise group will follow the online clinical mat pilates exercises (via Zoom application) accompanied by a physiotherapist. |
| Control Group | Active comparator | Other: online physical activity counsellingThe control group will receive online (via Zoom application) physical activity counselling by the physiotherapist only once. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients between the ages of 18 and 60
- Patients who volunteer
- Patients who can use technological devices at a level to participate in the online treatment
- Patients who completed a minimum of 8 weeks and a maximum of 2 years after surgery
Key exclusion criteria (3 listed)
- Patients who are pregnant
- Patients who have psychiatric or psychological disorders that may affect adherence to treatment
- Patients who have an orthopaedic, neurological, cardiac, pulmonary or metabolic condition that may prevent participation and continuation of the exercise program
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 |
|---|---|---|
| ExercisePatients in the exercise group will participate in online clinical pilates exercise sessions under the supervision of a physiotherapist twice a week. The exercises will be done via the Zoom application and will continue for 6 weeks. The exercise program will last one hour with a warm-up and cool-down period. The exercises will be done by adhering to the basic principles of clinical pilates. The exercise program includes mat exercises that provide general body strengthening and stretching. Progression will be provided according to the health status of the patients and their compliance with exercise. The intensity of exercise will be planned as medium according to the Rating of perceived exertion (RPE) Scale. | Other | Exercise Group |
| online physical activity counsellingCG will receive online physical activity counselling by a physiotherapist only once. The importance of physical activity after surgery and the points to be considered during physical activity will be explained to the patients. | Other | Control Group |
Primary outcome
The Senior Fitness Test
Time frame: 6 weeks
The Senior Fitness Test Battery is used to evaluate the functional status of the participants. This battery consisted of 6 different tests that assess cardiorespiratory fitness, muscle strength, endurance and flexibility. Although it is a test that is developed to assess the functional evaluation of elderly individuals, it is used for functional evaluation of cases with fibromyalgia and obesity.
Six-Minute Walk Test (6 MWT)
Time frame: 6 weeks
The 6 MWT is used to evaluate the aerobic endurance of the patients. 6 MWT will be done according to American Thoracic Society (ATS) criteria. This test requires patients to walk at their own walking pace, as fast as possible but without running, for 6 minutes on a 30-metre straight corridor and the distance covered in meters will be recorded. In addition, before and after saturation, heart rate, dyspnea and fatigue levels will be evaluated by pulse oximetry. Modified Borg Dyspnea and Fatigue Scales will be used to determine dyspnea and fatigue levels.
The Chair Stand Test
Time frame: 6 weeks
This test is used to assess lower extremity strength and function. This requires participants to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands will be recorded.
The Biceps Curl Test
Time frame: 6 weeks
This requires participants to repeatedly lift a 5 lb (2.27 kg) weight (for women) or an 8 lb (3.63 kg) weight (for men) for 30 seconds. The number of lifts will be recorded. This reflects upper body strength.
The Chair Sit and Reach Test
Time frame: 6 weeks
For the test, the individual is asked to reach towards the toes with both hands in a sitting position with one knee flexed, the other knee extended and the ankle flexed to 90 degrees. The distance between the tip of the finger and the tip of the toe is recorded in cm. The test is repeated three times, the best distance is recorded, and the test is repeated for both limbs. This reflects lower body flexibility.
The Back Scratch Test
Time frame: 6 weeks
One hand is extended over the shoulder and the other is extended up the middle of the back and the approach distance of the middle fingers is measured and recorded in centimetres (cm). The test is repeated three times, the best distance is recorded, and the test is repeated for both limbs. This reflects upper body flexibility.
8-Foot Up and Go Test
Time frame: 6 weeks
This test requires the patient to get up from the chair as quickly as possible, take 8 steps and sit back in the chair. The time that's spent is measured and recorded in seconds.
8 secondary outcomes
Muscle Strength
Time frame: 6 weeks
Core Stabilization
Time frame: 6 weeks
Obesity and Weight Loss Quality Of Life (OWLQOL)
Time frame: 6 weeks
Nottingham Health Profile
Time frame: 6 weeks
Body Fat Percentage
Time frame: 6 weeks
Muscle Mass
Time frame: 6 weeks
Body Mass Index (BMI)
Time frame: 6 weeks
Bone Mass
Time frame: 6 weeks
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 6 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and online physical activity counselling in people with Bariatric Surgery and Obesity, run by Istanbul 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 4 inclusion and 3 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 6 Mar 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?
The Senior Fitness Test (time frame: 6 weeks). The study lists 7 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 6 Mar 2024.