Clinical trial NCT02757092: The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery
Official title: The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Pulmonary rehabilitation
surgery
exercise
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in patients after thoracoscopy. After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge. The random assignment was performed based on simple randomization by using numbers from 1 to 36; numbered, sealed, opaque envelopes were used for allocation concealment. These envelopes were randomly distributed by non researchers and recorded.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. refusal to participate
2. unplanned emergency surgery
3. hemodynamic instability
4. received other surgery within a month postsurgery
5. unconsciousness after surgery
6. bedridden and upper or lower limb weakness
7. received radiation and chemotherapy postsurgery
8. implementation of thoracoscopic surgery for biopsy only

Primary outcomes:
measure: Discharge 2weeks Exercise Capacity
timeFrame: assessed at discharge 2weeks
measure: Discharge 6 Weeks Exercise Capacity
timeFrame: assessed at discharge.6weeks
measure: Discharge 12 Weeks Exercise Capacity
timeFrame: assessed at discharge 12 weeks
Secondary outcomes:
measure: Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)
timeFrame: assessments at 2 weeks after discharge
measure: Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
timeFrame: assessed at 2 weeks after discharge
measure: Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)
timeFrame: assessed at discharge 2weeks
measure: Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)
timeFrame: assessed at discharge 2weeks
measure: Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)
timeFrame: assessed at discharge 2 weeks.
measure: Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O)
timeFrame: assessed at discharge 2 weeks
measure: Discharge 2 Weeks Modified Borg Score
timeFrame: assessed at discharge 2 weeks
measure: Discharge 2weeks Lung Expansion Capacity
timeFrame: assessed at discharge 2 weeks
measure: Postoperative 2 Weeks Pulmonary Complications
timeFrame: at 2weeks after discharge
measure: Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec)
timeFrame: assessments at discharge 6 weeks
measure: Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec)
timeFrame: assessed at discharge 6weeks
measure: Discharge 6weeks MMEF 25-75%(Liter(L)/Sec)
timeFrame: assessed at discharge 6 weeks
measure: Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec)
timeFrame: assessed at discharge .6weeks
measure: Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O)
timeFrame: assessed at discharge6 weeks.
measure: Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O)
timeFrame: assessed at discharge 6 weeks
measure: Discharge 6 Weeks Modified Borg Score
timeFrame: assessed at discharge 6week
measure: Discharge 6weeks Lung Expansion Capacity
timeFrame: assessed at discharge 6 weeks
measure: Postoperative 6weeks Pulmonary Complications
timeFrame: at 6weeks after discharge
measure: Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec )
timeFrame: assessments at discharge 12 weeks
measure: Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
timeFrame: assessed at discharge12weeks
measure: Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec)
timeFrame: assessed at discharge12weeks "
measure: Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec)
timeFrame: assessed at discharge 12 weeks
measure: Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O)
timeFrame: assessed at discharge12 weeks.
measure: Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O)
timeFrame: assessed at discharge 12weeks
measure: Discharge 12 Weeks Modified Borg Score
timeFrame: assessed at discharge12weeks
measure: Discharge 12 Weeks Lung Expansion Capacity
timeFrame: assessed at discharge 12weeks
measure: Postoperative 12 Weeks Pulmonary Complications
timeFrame: at 12 weeks after discharge
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Niaosong
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Respiratory Therapy
name: Jui Fang Liu, PhD
role: STUDY_DIRECTOR
affiliation: Department of Respiratory Therapy
name: Nai Ying Kuo, master
role: STUDY_CHAIR
References: