The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Discharge 2weeks Exercise Capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Home-based rehabilitation program
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.
干预措施: Home-based Pulmonary Rehabilitation (Other)
standard care
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.
干预措施: Home-based Pulmonary Rehabilitation (Other)
结局指标
主要结局
Discharge 2weeks Exercise Capacity
时间窗: assessed at discharge 2weeks
Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.
Discharge 6 Weeks Exercise Capacity
时间窗: assessed at discharge.6weeks
Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.
Discharge 12 Weeks Exercise Capacity
时间窗: assessed at discharge 12 weeks
Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome.
次要结局
- Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)(assessed at discharge 2weeks)
- Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)(assessed at discharge 2weeks)
- Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)(assessed at discharge 2 weeks.)
- Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O)(assessed at discharge 2 weeks)
- Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)(assessments at 2 weeks after discharge)
- Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)(assessed at 2 weeks after discharge)
- Discharge 2 Weeks Modified Borg Score(assessed at discharge 2 weeks)
- Discharge 2weeks Lung Expansion Capacity(assessed at discharge 2 weeks)
- Postoperative 2 Weeks Pulmonary Complications(at 2weeks after discharge)
- Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec)(assessments at discharge 6 weeks)
- Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec)(assessed at discharge 6weeks)
- Discharge 6weeks MMEF 25-75%(Liter(L)/Sec)(assessed at discharge 6 weeks)
- Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec)(assessed at discharge .6weeks)
- Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O)(assessed at discharge6 weeks.)
- Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O)(assessed at discharge 6 weeks)
- Discharge 6 Weeks Modified Borg Score(assessed at discharge 6week)
- Discharge 6weeks Lung Expansion Capacity(assessed at discharge 6 weeks)
- Postoperative 6weeks Pulmonary Complications(at 6weeks after discharge)
- Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec )(assessments at discharge 12 weeks)
- Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)(assessed at discharge12weeks)
- Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec)(assessed at discharge12weeks ")
- Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec)(assessed at discharge 12 weeks)
- Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O)(assessed at discharge12 weeks.)
- Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O)(assessed at discharge 12weeks)
- Discharge 12 Weeks Modified Borg Score(assessed at discharge12weeks)
- Discharge 12 Weeks Lung Expansion Capacity(assessed at discharge 12weeks)
- Postoperative 12 Weeks Pulmonary Complications(at 12 weeks after discharge)
研究者
Liu Jui Fang
Respiratory therapist
Chang Gung Memorial Hospital