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Completed

NCT Number: NCT04151836

Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients

This study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in Taiwan.

Hypothesis:

1. The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month. 2. The quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.

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Key information

Conditions

Exercise Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

This study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in Taiwan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • After the research purpose is stated, the subject agrees and is willing to participate in the researcher and is willing to sign a written consent form.
  • 20-60 years old, with clear consciousness, can communicate with the Mandarin and Taiwanese, and are willing to conduct this research.
  • Body mass index according to the Asia Pacific implementation of Bariatric surgery indications, BMI≧37 Kg/m2 or BMI≧32 Kg/m2 combined with metabolic diseases caused by obesity, such as cardiovascular disease, type 2 diabetes, Obstructive Sleep Apnea(OSA), nonalcoholic fatty liver, and degenerative arthritis.
  • Patients with morbid obesity undergoing laparoscopic gastric sleeve resection or laparoscopic gastric bypass surgery.
  • Explain how the smart phone application (Google Fit) and (68 Heart Rate Monitor) are used, and the patient or family member can be operated after returning home.

Exclusion criteria

  • After the attending physician evaluates,medical order presentation a person who cannot perform exercise prescriptions.
  • Lower limb limb disorders or amputations cannot coordinate with exercise prescription.
  • Poorly controlled cardiovascular diseases such as arrhythmia, angina, heart failure,myocardial infarction, and chest pain during activities or rest in the past three months.
  • Patients with poor diabetes control, glycosylated hemoglobin (HbA1C) > 9%, with eye lesions or neuropathy.
  • Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg when quiet.
  • Heart rate is greater than 100bpm when quiet.

Treatment and study plan

Exercise Education

Other

weekly telephone or mobile application "LINE" consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.

Primary outcomes

  1. BMI

    Time frame: baseline(one weeks after recruited)

    using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)

  2. BMI

    Time frame: 1st month after recruited

    using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)

  3. BMI

    Time frame: 2nd month after recruited

    using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)

  4. BMI

    Time frame: 3rd month after recruited

    using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)

  5. objective body composition index

    Time frame: baseline(one weeks after recruited)

    using bioelectric impedance(BIA) to measure body composition

  6. objective body composition index

    Time frame: 1st month after recruited

    using bioelectric impedance(BIA) to measure body composition

  7. objective body composition index

    Time frame: 2nd month after recruited

    using bioelectric impedance(BIA) to measure body composition

  8. objective body composition index

    Time frame: 3rd month after recruited

    using bioelectric impedance(BIA) to measure body composition

  9. Waistline and Waist to hip ratio

    Time frame: baseline(one weeks after recruited)

    using a tape to measure Waistline and Waist to hip ratio.

  10. Waistline and Waist to hip ratio

    Time frame: 1st month after recruited

    using a tape to measure Waistline and Waist to hip ratio.

  11. Waistline and Waist to hip ratio

    Time frame: 2nd month after recruited

    using a tape to measure Waistline and Waist to hip ratio.

  12. Waistline and Waist to hip ratio

    Time frame: 3rd month after recruited

    using a tape to measure Waistline and Waist to hip ratio.

Secondary outcomes

  1. Short Form 36(SF-36)

    Time frame: baseline(one weeks after recruited)

    The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living.

  2. Short Form 36(SF-36)

    Time frame: 1st month after recruited

    The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living.

  3. Short Form 36(SF-36)

    Time frame: 2nd month after recruited

    The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living.

  4. Short Form 36(SF-36)

    Time frame: 3rd month after recruited

    The SF-36 provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.the scores ranging from 0 to 100. the higher the score, the better the quality of healthy living.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2019
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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