The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery (VATSMIPMEP)

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Chang Gung Medical Foundation

Status

Completed

Conditions

Lung Neoplasms

Treatments

Other: Home-based Pulmonary Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT02757092
1046659A3

Details and patient eligibility

About

The advantages of thoracoscopic surgery include smaller wounds, fewer postoperative complications, and shortened hospital stay. However,complications such as pain, pulmonary function insufficiency, pneumonia,postoperative pneumothorax, persistent air leakage, subcutaneous emphysema, cough, and hemoptysis may occur in older patients after thoracoscopic surgery. Pulmonary rehabilitation has been demonstrated by evidence-base medicine could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery. Studies have suggested that pulmonary rehabilitation should be performed for at least 4 weeks to optimize the training effect .However, most patients who undergo thoracoscopic surgery were discharged within 3-5 days. Such a short hospital stay impeded the delivery of pulmonary rehabilitation. Home-based pulmonary rehabilitation appeared to be an option for these patients The purpose of this study is to determine whether Pulmonary rehabilitation are effective on patients who had thoracic surgeries.

Full description

Pulmonary-related surgeries remain some potential risks according to the previous evidence-based studies. Particularly, individuals who were over 65 years of age with smoking, chronic pulmonary disease, wheezy, cardiovascular comorbidities, upper respiratory infection were at the high risk of pulmonary complications after surgery,which accounted for approximately 2% to 40% of occurrence rate. The average mortality rate due to surgery was approximately 2%-8% in patients aged more than 65 years.Pulmonary rehabilitation could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery.But efficacy of home-based pulmonary rehabilitation for older adults following thoracoscopic surgery, it has not received much attention. This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in older adults after VATS. All participants underwent preoperative and initial postoperative pulmonary rehabilitation during their hospital stay and were randomly assigned to the experimental or control group at the time of discharge. The control group received standard health education, whereas the experimental group received home-based pulmonary rehabilitation in addition to standard health education. Objective and personal subjective outcome measurements were performed before hospital discharge and 2, 6, and 12 weeks after discharge The control group received standard care. Considering the principle for exercise progression, we divided the home-based rehabilitation program into two stages (0-2 weeks and 3-6 weeks).The exercise program was adjusted in the second week when patients visited the outpatient department of the hospital for follow-up. The home-based rehabilitation program included (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure. In the second stage (3-6 weeks), the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min). Incentive spirometry training (Triflo-II) was performed 8-10 times per hour, and a threshold load trainer was used to train the inspiratory muscle (30 breaths each time, twice per day), with the pressure intensity adjusted to more than 5% of that in the first stage.Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and to encourage patients to continue their rehabilitation program.

Enrollment

36 patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed consent
  • The men and women over the age of 65
  • admission to undergo VATS.
  • consciousness and ability to communicate
  • ability to undergo 6 weeks of a home-based pulmonary rehabilitation program

Exclusion criteria

  • refusal to participate
  • unplanned emergency surgery
  • hemodynamic instability
  • received other surgery within a month postsurgery
  • unconsciousness after surgery
  • bedridden and upper or lower limb weakness
  • received radiation and chemotherapy postsurgery
  • implementation of thoracoscopic surgery for biopsy only

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Home-based rehabilitation program
Experimental group
Description:
0-2 weeks,1. aerobic exercise intensity was targeted to reach 10-11 points of perceived exercise (RPE) scale 2. raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min 3.walked at a comfortable speed for 15 min twice per day.4. Triflo-II was performed 8-10 times per hour. inspiratory muscle training with the initial pressure set at 25%-30% of the maximum inspiratory pressure.3-6 weeks, aerobic exercise reach 12-15 points on the RPE scale. upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day , walking exercise for a total of 30 min. Triflo-II was performed 8-10 times per hour, and train the inspiratory muscle with the pressure intensity adjusted to more than 5% of that in the first stage.
Treatment:
Other: Home-based Pulmonary Rehabilitation
standard care
Active Comparator group
Description:
control group accept the pulmonary rehabilitation (breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation.
Treatment:
Other: Home-based Pulmonary Rehabilitation

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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