ExerciseNCT04151836
Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
A study testing Exercise education in people with Exercise, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Exercise
- What is being tested?
- Exercise education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jan 2020to 23 Feb 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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.
Hypothesis:
- The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.
- The quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.
Read the 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.
- Conditions
- Exercise
- Being tested
- Exercise education
- Keywords
- Bariatric surgery, Body composition, Morbid obesity, Quality of life, Walking exercise
- Medical subject headings
- Motor Activity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | exercise education: A 12-week regimen of home-based walking exercises, include moderate intensity 30 minutes of exercise in week 1-4,40 minutes of exercise in 5-8 weeks,50 minutes in the 9-12 week,three times weekly in three month.We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 65%-70% of the target Maximal heart rate(HRmax). Receives: Other: Exercise education |
| control group | No intervention | These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
Measured: baseline(one weeks after recruited)
BMI
using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
Measured: 1st month after recruited
BMI
using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
Measured: 2nd month after recruited
BMI
using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
Measured: 3rd month after recruited
objective body composition index
using bioelectric impedance(BIA) to measure body composition
Measured: baseline(one weeks after recruited)
objective body composition index
using bioelectric impedance(BIA) to measure body composition
Measured: 1st month after recruited
objective body composition index
using bioelectric impedance(BIA) to measure body composition
Measured: 2nd month after recruited
objective body composition index
using bioelectric impedance(BIA) to measure body composition
Measured: 3rd month after recruited
Waistline and Waist to hip ratio
using a tape to measure Waistline and Waist to hip ratio.
Measured: baseline(one weeks after recruited)
Waistline and Waist to hip ratio
using a tape to measure Waistline and Waist to hip ratio.
Measured: 1st month after recruited
Waistline and Waist to hip ratio
using a tape to measure Waistline and Waist to hip ratio.
Measured: 2nd month after recruited
Waistline and Waist to hip ratio
using a tape to measure Waistline and Waist to hip ratio.
Measured: 3rd month after recruited
Secondary outcomes (4)
Short Form 36(SF-36)
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.
Measured: baseline(one weeks after recruited)
Short Form 36(SF-36)
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.
Measured: 1st month after recruited
Short Form 36(SF-36)
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.
Measured: 2nd month after recruited
Short Form 36(SF-36)
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.
Measured: 3rd month after recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start9 Jan 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Mei Chen, PhD, Study chair, alice@ntunhs.edu.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151836
- Sponsor's protocol ID
- 201901602A3
- Status last verified
- Oct 2020
- First submitted
- 3 Nov 2019
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data that underline results in a publication
Publications
Robert M, Ferrand-Gaillard C, Disse E, Espalieu P, Simon C, Laville M, Gouillat C, Thivolet C. Predictive factors of type 2 diabetes remission 1 year after bariatric surgery: impact of surgical techniques. Obes Surg. 2013 Jun;23(6):770-5. doi: 10.1007/s11695-013-0868-4.
PubMed 23355293Janik MR, Rogula T, Bielecka I, Kwiatkowski A, Pasnik K. Quality of Life and Bariatric Surgery: Cross-Sectional Study and Analysis of Factors Influencing Outcome. Obes Surg. 2016 Dec;26(12):2849-2855. doi: 10.1007/s11695-016-2220-2.
PubMed 27179520Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
PubMed 18392907Woodlief TL, Carnero EA, Standley RA, Distefano G, Anthony SJ, Dubis GS, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Dose response of exercise training following roux-en-Y gastric bypass surgery: A randomized trial. Obesity (Silver Spring). 2015 Dec;23(12):2454-61. doi: 10.1002/oby.21332. Epub 2015 Nov 5.
PubMed 26537198Carnero EA, Dubis GS, Hames KC, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Randomized trial reveals that physical activity and energy expenditure are associated with weight and body composition after RYGB. Obesity (Silver Spring). 2017 Jul;25(7):1206-1216. doi: 10.1002/oby.21864. Epub 2017 May 30.
PubMed 28558160Castello V, Simoes RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4.
PubMed 21104041Campanha-Versiani L, Pereira DAG, Ribeiro-Samora GA, Ramos AV, de Sander Diniz MFH, De Marco LA, Soares MMS. The Effect of a Muscle Weight-Bearing and Aerobic Exercise Program on the Body Composition, Muscular Strength, Biochemical Markers, and Bone Mass of Obese Patients Who Have Undergone Gastric Bypass Surgery. Obes Surg. 2017 Aug;27(8):2129-2137. doi: 10.1007/s11695-017-2618-5.
PubMed 28285470Kolotkin RL, LaMonte MJ, Litwin S, Crosby RD, Gress RE, Yanowitz FG, Hunt SC, Adams TD. Cardiorespiratory fitness and health-related quality of life in bariatric surgery patients. Obes Surg. 2011 Apr;21(4):457-64. doi: 10.1007/s11695-010-0261-5.
PubMed 20820940
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT04151836
- Acronym / sponsor ID
- 201901602A3
- Conditions
- Exercise
- Keywords
- Bariatric surgery, Body composition, Morbid obesity, Quality of life, Walking exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 5 Nov 2019 (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.
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:
- The body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Exercise educationexercise education: A 12-week regimen of home-based walking exercises, include moderate intensity 30 minutes of exercise in week 1-4,40 minutes of exercise in 5-8 weeks,50 minutes in the 9-12 week,three times weekly in three month.We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 65%-70% of the target Maximal heart rate(HRmax). |
| control group | No intervention | –These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Exercise educationweekly 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. | Other | exercise group |
Primary outcome
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)
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)
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)
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)
objective body composition index
Time frame: baseline(one weeks after recruited)
using bioelectric impedance(BIA) to measure body composition
objective body composition index
Time frame: 1st month after recruited
using bioelectric impedance(BIA) to measure body composition
objective body composition index
Time frame: 2nd month after recruited
using bioelectric impedance(BIA) to measure body composition
objective body composition index
Time frame: 3rd month after recruited
using bioelectric impedance(BIA) to measure body composition
Waistline and Waist to hip ratio
Time frame: baseline(one weeks after recruited)
using a tape to measure Waistline and Waist to hip ratio.
Waistline and Waist to hip ratio
Time frame: 1st month after recruited
using a tape to measure Waistline and Waist to hip ratio.
Waistline and Waist to hip ratio
Time frame: 2nd month after recruited
using a tape to measure Waistline and Waist to hip ratio.
Waistline and Waist to hip ratio
Time frame: 3rd month after recruited
using a tape to measure Waistline and Waist to hip ratio.
4 secondary outcomes
Short Form 36(SF-36)
Time frame: baseline(one weeks after recruited)
Short Form 36(SF-36)
Time frame: 1st month after recruited
Short Form 36(SF-36)
Time frame: 2nd month after recruited
Short Form 36(SF-36)
Time frame: 3rd month after recruited
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 11 Jun 2021.
- Results publication: PubMed 23355293Robert M, Ferrand-Gaillard C, Disse E, Espalieu P, Simon C, Laville M, Gouillat C, Thivolet C. Predictive factors of type 2 diabetes remission 1 year after bariatric surgery: impact of surgical techniques. Obes Surg. 2013 Jun;23(6):770-5. doi: 10.1007/s11695-013-0868-4.
- Results publication: PubMed 27179520Janik MR, Rogula T, Bielecka I, Kwiatkowski A, Pasnik K. Quality of Life and Bariatric Surgery: Cross-Sectional Study and Analysis of Factors Influencing Outcome. Obes Surg. 2016 Dec;26(12):2849-2855. doi: 10.1007/s11695-016-2220-2.
- Results publication: PubMed 18392907Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
- Results publication: PubMed 26537198Woodlief TL, Carnero EA, Standley RA, Distefano G, Anthony SJ, Dubis GS, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Dose response of exercise training following roux-en-Y gastric bypass surgery: A randomized trial. Obesity (Silver Spring). 2015 Dec;23(12):2454-61. doi: 10.1002/oby.21332. Epub 2015 Nov 5.
- Results publication: PubMed 28558160Carnero EA, Dubis GS, Hames KC, Jakicic JM, Houmard JA, Coen PM, Goodpaster BH. Randomized trial reveals that physical activity and energy expenditure are associated with weight and body composition after RYGB. Obesity (Silver Spring). 2017 Jul;25(7):1206-1216. doi: 10.1002/oby.21864. Epub 2017 May 30.
- Results publication: PubMed 21104041Castello V, Simoes RP, Bassi D, Catai AM, Arena R, Borghi-Silva A. Impact of aerobic exercise training on heart rate variability and functional capacity in obese women after gastric bypass surgery. Obes Surg. 2011 Nov;21(11):1739-49. doi: 10.1007/s11695-010-0319-4.
- Results publication: PubMed 28285470Campanha-Versiani L, Pereira DAG, Ribeiro-Samora GA, Ramos AV, de Sander Diniz MFH, De Marco LA, Soares MMS. The Effect of a Muscle Weight-Bearing and Aerobic Exercise Program on the Body Composition, Muscular Strength, Biochemical Markers, and Bone Mass of Obese Patients Who Have Undergone Gastric Bypass Surgery. Obes Surg. 2017 Aug;27(8):2129-2137. doi: 10.1007/s11695-017-2618-5.
- Results publication: PubMed 20820940Kolotkin RL, LaMonte MJ, Litwin S, Crosby RD, Gress RE, Yanowitz FG, Hunt SC, Adams TD. Cardiorespiratory fitness and health-related quality of life in bariatric surgery patients. Obes Surg. 2011 Apr;21(4):457-64. doi: 10.1007/s11695-010-0261-5.
- Obesity and overweightLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. individual participant data that underline results in a publication
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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.
Hui-Mei Chen, PhD study chair
alice@ntunhs.edu.tw
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 education in people with Exercise, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 6 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 11 Jun 2021. 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 Taiwan. 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?
BMI (time frame: baseline(one weeks after recruited)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151836, which also lists 8 linked publications.
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 11 Jun 2021.