Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery

March 5, 2024 updated by: Goksen Kuran Aslan, Istanbul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ayça Arslantürk, PT

Study Contact Backup

  • Name: Goksen Kuran Aslan, Assoc. Prof.
  • Phone Number: 40167 +90 (212) 414 15 28
  • Email: goksenkuran@yahoo.com

Study Locations

  • Turkey
      • Istanbul, Turkey, 34320
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise Group
The exercise group will follow the online clinical mat pilates exercises (via Zoom application) accompanied by a physiotherapist.
Other: Exercise
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.
Active Comparator: Control Group
The control group will receive online (via Zoom application) physical activity counselling by the physiotherapist only once.
Other: online physical activity counselling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: 6 weeks
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.
6 weeks
Core Stabilization
Time Frame: 6 weeks
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.
6 weeks
Obesity and Weight Loss Quality Of Life (OWLQOL)
Time Frame: 6 weeks
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.
6 weeks
Nottingham Health Profile
Time Frame: 6 weeks
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.
6 weeks
Body Fat Percentage
Time Frame: 6 weeks
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.
6 weeks
Muscle Mass
Time Frame: 6 weeks
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.
6 weeks
Body Mass Index (BMI)
Time Frame: 6 weeks
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.
6 weeks
Bone Mass
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/GAslan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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