Online Clinic Pilates Exercises in Patients Undergoing Bariatric Surgery

NCT05454696 | Completed

• 1 other identifier: 2022/GAslan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bariatric Surgery; Obesity; Exercise; Physical Activity

Keywords

Physical Fitness; Exercise; Pilates; Quality of Life

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 weeks

Secondary Outcomes (8)

• Muscle Strength

  6 weeks

• Core Stabilization

  6 weeks

• Obesity and Weight Loss Quality Of Life (OWLQOL)

  6 weeks

• Nottingham Health Profile

  6 weeks

• Body Fat Percentage

  6 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

The exercise group will follow the online clinical mat pilates exercises (via Zoom application) accompanied by a physiotherapist.

Other: Exercise

Control Group

ACTIVE COMPARATOR

The control group will receive online (via Zoom application) physical activity counselling by the physiotherapist only once.

Other: online physical activity counselling

Interventions

Exercise OTHER

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.

Exercise Group

online physical activity counselling OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: September 19, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)