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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04151836
Enrollment
85
Registered
2019-11-05
Start date
2020-01-09
Completion date
2021-02-23
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise

Keywords

Bariatric surgery, Body composition, Morbid obesity, Quality of life, Walking exercise

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

A statistician who did not participate in the study randomly assigned patients to the experimental or control group according to the list generated by the computer software.

Intervention model description

Both groups were tested by demographic characteristics, dietary behavior measurement, SF-36 Questionnaire and body composition analyzer for the same project. The experimental group needs to cooperate with the moderate-intensity walking exercise training prescription for 3 times a week ; Control group no exercise intervention.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. 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. 2. 20-60 years old, with clear consciousness, can communicate with the Mandarin and Taiwanese, and are willing to conduct this research. 3. 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. 4. Patients with morbid obesity undergoing laparoscopic gastric sleeve resection or laparoscopic gastric bypass surgery. 5. 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

1. After the attending physician evaluates,medical order presentation a person who cannot perform exercise prescriptions. 2. Lower limb limb disorders or amputations cannot coordinate with exercise prescription. 3. Poorly controlled cardiovascular diseases such as arrhythmia, angina, heart failure,myocardial infarction, and chest pain during activities or rest in the past three months. 4. Patients with poor diabetes control, glycosylated hemoglobin (HbA1C) \> 9%, with eye lesions or neuropathy. 5. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg when quiet. 6. Heart rate is greater than 100bpm when quiet.

Design outcomes

Primary

MeasureTime frameDescription
BMIbaseline(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)
objective body composition indexbaseline(one weeks after recruited)using bioelectric impedance(BIA) to measure body composition
Waistline and Waist to hip ratiobaseline(one weeks after recruited)using a tape to measure Waistline and Waist to hip ratio.

Secondary

MeasureTime frameDescription
Short Form 36(SF-36)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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026