Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
9. Juni 2021 aktualisiert von: Chang Gung Memorial Hospital
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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
85
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: exercise group
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).
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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.
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Kein Eingriff: control group
These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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BMI
Zeitfenster: baseline(one weeks after recruited)
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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baseline(one weeks after recruited)
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BMI
Zeitfenster: 1st month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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1st month after recruited
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BMI
Zeitfenster: 2nd month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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2nd month after recruited
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BMI
Zeitfenster: 3rd month after recruited
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using bioelectric impedance(BIA) to measure BMI.the weight in kilograms divided by the square of the height in meters(Kg/m2)
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3rd month after recruited
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objective body composition index
Zeitfenster: baseline(one weeks after recruited)
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using bioelectric impedance(BIA) to measure body composition
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baseline(one weeks after recruited)
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objective body composition index
Zeitfenster: 1st month after recruited
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using bioelectric impedance(BIA) to measure body composition
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1st month after recruited
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objective body composition index
Zeitfenster: 2nd month after recruited
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using bioelectric impedance(BIA) to measure body composition
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2nd month after recruited
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objective body composition index
Zeitfenster: 3rd month after recruited
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using bioelectric impedance(BIA) to measure body composition
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3rd month after recruited
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Waistline and Waist to hip ratio
Zeitfenster: baseline(one weeks after recruited)
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using a tape to measure Waistline and Waist to hip ratio.
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baseline(one weeks after recruited)
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Waistline and Waist to hip ratio
Zeitfenster: 1st month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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1st month after recruited
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Waistline and Waist to hip ratio
Zeitfenster: 2nd month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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2nd month after recruited
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Waistline and Waist to hip ratio
Zeitfenster: 3rd month after recruited
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using a tape to measure Waistline and Waist to hip ratio.
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3rd month after recruited
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Short Form 36(SF-36)
Zeitfenster: baseline(one weeks after recruited)
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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.
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baseline(one weeks after recruited)
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Short Form 36(SF-36)
Zeitfenster: 1st month after recruited
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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.
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1st month after recruited
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Short Form 36(SF-36)
Zeitfenster: 2nd month after recruited
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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.
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2nd month after recruited
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Short Form 36(SF-36)
Zeitfenster: 3rd month after recruited
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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.
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3rd month after recruited
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Hui-Mei Chen, PhD, alice@ntunhs.edu.tw
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Magro 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.
- 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.
- Janik 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.
- Woodlief 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.
- Carnero 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.
- Castello 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.
- Campanha-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.
- Kolotkin 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
9. Januar 2020
Primärer Abschluss (Tatsächlich)
23. Februar 2021
Studienabschluss (Tatsächlich)
23. Februar 2021
Studienanmeldedaten
Zuerst eingereicht
3. November 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. November 2019
Zuerst gepostet (Tatsächlich)
5. November 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2021
Zuletzt verifiziert
1. Oktober 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 201901602A3
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
individual participant data that underline results in a publication
IPD-Sharing-Zeitrahmen
starting 12 months after publication
IPD-Sharing-Zugriffskriterien
individual participant data that underline the results reported in this article,after deidentification(test,table,figures,and appendices)
Art der unterstützenden IPD-Freigabeinformationen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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