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临床试验/NCT04880486
NCT04880486已完成不适用

Effects of Weight Training With VR on Pulmonary Function, Exercise Capacity and Quality of Life in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Muscle Strength

研究概览

简要总结

Using weight training with virtual reality can help after discharge patients of acute exacerbation of chronic obstructive pulmonary disease, which maintained their quality of life, and improved their exercise capacity, pulmonary function, readmission condition.

详细描述

Chronic obstructive pulmonary disease (COPD) is a type obstructive lung disease which had become the third leading cause of deaths worldwide. The main symptoms including dyspnea, coughing, sputum production and acute exacerbation of COPD (AECOPD). The physical activity level, muscle power, exercise tolerance and quality of life (QoL) would decline rapidly when an episode of AECOPD occurred, with the worsen of the pulmonary function and activities level, the patient would get weaker and mortality rate would increase. Pulmonary rehabilitation (PR) had become a common-used clinical programs which including (but not limit to) medication, education, psychological support, nutrition consultation and exercise interventions.

In PR programs, exercise had been specifically pointed out for its improvement of physical activity level and quality of life, however, the adherence rate of programs remains low due to lack of motivation and insufficient training effect. Previous interventions preferred aerobic exercise conducting in sitting position considering the long-term sedentary life style of patients. However, such an intervention demonstrated little effect on increasing muscle power of lower extremities, results in insufficient physical activity level and functional performance. Besides, the interventions are usually single and repeatedly limb movement exercise which fail to brings up interests and results in poor motivation of the patients. Literatures review has suggested the highly involvement of upper extremities which is strongly contributed to independently daily living. The implantation of virtual reality in PR program has gained attentions with its advantage of facilitate the motivation. Therefore, the study aims to conduct the muscle strength training including both upper and lower extremities with the combination of virtual reality (VR). Anticipated result expects to provide a research evidence of innovative pulmonary rehabilitation exercise intervention.

The study will recruited 30 participants who will be randomly divided into control and intervention group. Control group will receive routine pulmonary rehabilitation including medication and education, the research stuff will give a brief explanation of home exercise, and weekly telemedicine to follow the exercise intensity and provide conciliation. Intervention group will receive the routine medical care. Extra weight training program targeting on upper extremities with the VR headsets will be conducted with the accompany of the research stuff. 3 times a week for 8 weeks (as a 24-times interference totally) interventions with muscle strength, exercise capacity, pulmonary function and improvement of quality of life will be assess to investigate the training effects. Expected result including the progression of muscle strength, oxygen uptake level, as well as pulmonary performance. The implantation of VR will also improve the motivation to participant, which will further alleviate the symptoms and quality of life. It can also provide some research evidence for clinical therapist to conduct an individualized exercise prescription for COPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •hospitalization due to acute exacerbation of chronic obstructive pulmonary disease in preceding 1-year history
  • •age was between 40 to 85 years old

排除标准

  • •having a pulmonary rehabilitation in the past 1 month
  • •comorbidities that don't suitable for pulmonary rehabilitation, such as, untreatable cardiovascular disease, sinus tachycardia (HR>120), hypertension at rest if not adequately controlled, resting systolic blood pressure < 90 mmHg, and exercise contraindication
  • •advanced cancer with fatigue syndrome
  • •can't follow the orders
  • •physical impairment
  • •psychological impairment

研究组 & 干预措施

Exercise group

Experimental

usually care with extra supervision upper limb exercise with VR

干预措施: Education (Other)

Control group

Sham Comparator

usually care with extra health education on upper limb exercise

干预措施: Education (Other)

Exercise group

Experimental

usually care with extra supervision upper limb exercise with VR

干预措施: Supervision upper limb weight training exercise with VR (Other)

结局指标

主要结局

Muscle Strength

时间窗: 12 weeks

using handhold dynamometer to test 5 motions for bilateral side for 3 times.

Cardiopulmonary exercise function test

时间窗: 12 weeks

using CPET to test for the maximal exercise performance of participant

Muscle Strength

时间窗: baseline

using handhold dynamometer to test 5 motions for bilateral side for 3 times.

Muscle Strength

时间窗: 4 weeks

using handhold dynamometer to test 5 motions for bilateral side for 3 times.

Muscle Strength

时间窗: 8 weeks

using handhold dynamometer to test 5 motions for bilateral side for 3 times.

Cardiopulmonary exercise function test

时间窗: baseline

using CPET to test for the maximal exercise performance of participant

Cardiopulmonary exercise function test

时间窗: 4 weeks

using CPET to test for the maximal exercise performance of participant

Cardiopulmonary exercise function test

时间窗: 8 weeks

using CPET to test for the maximal exercise performance of participant

次要结局

  • Quality of life questionnaire(4 times (baseline, 4 weeks, 8 weeks, 12 weeks))
  • Respiratory muscle force(4 times (baseline, 4 weeks, 8 weeks, 12 weeks))
  • Pulmonary function test(4 times (baseline, 4 weeks, 8 weeks, 12 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ching-Hsia Hung

Professor

National Cheng-Kung University Hospital

研究点 (1)

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