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The Effect of Chest Physiotherapy After Bariatric Surgery

21 de mayo de 2019 actualizado por: TOMRIS DUYMAZ, Istanbul Bilgi University

The Effect of Chest Physiotherapy After Bariatric Surgery on Pulmonary Functions, Functional Capacity and Quality of Life

The aim of this study was to investigate the effect of chest physiotherapy applied to patients undergoing bariatric surgery on pulmonary functions, dyspnea levels, functional capacity and quality of life.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

148

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • İstanbul, Pavo, 34440
        • Tomri̇s Duymaz

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Only mobilization was applied twice a day, 8 times in total.
Comparador de placebos: Group 2
only mobilisation was applied to the patients in the second group
Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
Only mobilization was applied twice a day, 8 times in total.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body mass index
Periodo de tiempo: 1 minute
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.
1 minute

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional capacity: 6 minute walk test
Periodo de tiempo: 5 minutes
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
5 minutes
Dispnea: Borg scale
Periodo de tiempo: 6 minutes
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.
6 minutes
Quality of Life profile: Nottingham Health Profile
Periodo de tiempo: 8 minutes
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.
8 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2018

Finalización primaria (Actual)

1 de octubre de 2018

Finalización del estudio (Actual)

15 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

27 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

28 de noviembre de 2018

Publicado por primera vez (Actual)

29 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IBU11.2018

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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