- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03758898
The Effect of Chest Physiotherapy After Bariatric Surgery
The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
This randomized, controlled trial, was designed, conducted, and reported in accordance with the standards of The CONSORT (Consolidated Standards of Reporting Trials) Statement. The patients were randomised and divided into two groups each comprising 74 patients. Chest physiotherapy and mobilisation was applied to the patients in the first group, and only mobilisation was applied to the patients in the second group. The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day. Chest physiotherapy and mobilization were applied twice a day, 8 times in total. The following parameters were evaluated preoperative and postoperative:arterial blood gas, oxygen saturation, respiratory function test for pulmonary functions, pulmonary artery pressure for pulmonary hypertansion, Borg dyspnea score for severity of dyspnoea, 6-minute walk test for functional capacity, Nottingham health profile for quality of life.
Chest physiotherapy consisted of postural drainage (30-45 degree eleve), breathing exercises (deep breathing, diaphragm breathing, active breathing techniques cycle) and coughing techniques (huffing, controlled coughing, manual assisted coughing). In the chest physiotherapy program, diaphragmatic respiration, constrictive lip respiration, segmental respiration, incentive spirometry and coughing were performed on the 1st postoperative day. All respiratory exercises were repeated twice a day and percussion was added on the 2nd postoperative day. All respiratory exercises and percussion were repeated 2 times a day until the discharge of the post op day 4 until discharge, and the work with incentive spirometry was removed per hour. Patients were mobilized as early as possible by the physiotherapist. The patients in both groups were instructed to sit out of bed and stand up on the first postoperative day, walk 45 m in the corridor on the second day, walk freely (approximately 150-300 m) on the third and the fourth days.
All operations were laparoscopic, sleeve gastrectomy or Roux-en Y gastric bypass (21). Routine anesthesia was performed with desflurane and remifentanil. In all procedures, patients were treated with the split upward position (French position) and a semi-reclining position (anti-Trendelenburg position). All patients received prophylaxis against deep vein thrombosis for 2 weeks with pneumatic compression stocking and subcutaneous low molecular weight heparin. Perioperative antibiotics (cefazolin 2 g) were also routinely administered. The patients were discharged on the fourth postoperative day.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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İstanbul, Turkki, 34440
- Tomri̇s Duymaz
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- obese and morbidly obese patients
- aged between 30 and 50 years
Exclusion Criteria:
- previous obesity surgery
- presence of chronic respiratory disease
- renal / hepatic dysfunction
- malignant hyperthermia
- regular alcohol
- smoking and drug use
- pregnancy.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Treatment
Chest physiotherapy and mobilisation were applied on the patients for 4 days.
The treatment of the patients was started on the first postoperative day and continued until the postoperative 4th day.
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Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Only mobilization was applied twice a day, 8 times in total.
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Placebo Comparator: Group 2
only mobilisation was applied to the patients in the second group
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Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Only mobilization was applied twice a day, 8 times in total.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Body mass index
Aikaikkuna: 1 minute
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BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.
The National Institutes of Health (NIH) now defines normal weight, overweight, and obesity according to BMI rather than the traditional height/weight charts.
Overweight is a BMI of 27.3 or more for women and 27.8 or more for men.
Obesity is a BMI of 30 or more for either sex (about 30 pounds overweight).
A very muscular person might have a high BMI without health risks.
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1 minute
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Functional capacity: 6 minute walk test
Aikaikkuna: 5 minutes
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The subjects were instructed to walk as far as possible in six minutes in an enclosed 50-m long hospital corridor.
Standardized encouragement was given in every 30 s.
The maximum distance covered at the end of the test was recorded
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5 minutes
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Dispnea: Borg scale
Aikaikkuna: 6 minutes
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Breathlessness and fatigue perception were determined using a 10-point modified Borg scale during the six minute walking test.
Total score is 10 points.
"This is a scale that asks you to rate the difficulty of your breathing.
It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
How much difficulty is your breathing causing you right now?" 0 better, 10 worst point mean.
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6 minutes
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Quality of Life profile: Nottingham Health Profile
Aikaikkuna: 8 minutes
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Nottingham Health Profile (NHP) was used to determine quality of life of the participants.
NHP is a general health status scale (health-related quality of life), which aims to measure a patient's perceived emotional, social and physical health status.
This scale consists of 38 items formed as yes-no questions that cover 6 subscales of the quality of life.
These six subscales are sleep (5 item), energy level (3 item), emotional status (9 item), social isolation (5 item), physical mobility (8 item) and pain (8 item).
Each section is scored from 0-100.
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8 minutes
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IBU11.2018
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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