Clinical trial NCT04880486: Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
COPD Exacerbation
Pulmonary Rehabilitation
Weight Training
Virtual Reality
Muscle Strength
Pulmonary Function
Quality of Life
Readmission
Keywords: Acute exacerbation of chronic obstructive pulmonary disease
upper extremity weight training
virtual reality
exercise capacity
functional capacity
adherence rate of exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Muscle Strength
timeFrame: baseline
measure: Muscle Strength
timeFrame: 4 weeks
measure: Muscle Strength
timeFrame: 8 weeks
measure: Muscle Strength
timeFrame: 12 weeks
measure: Cardiopulmonary exercise function test
timeFrame: baseline
measure: Cardiopulmonary exercise function test
timeFrame: 4 weeks
measure: Cardiopulmonary exercise function test
timeFrame: 8 weeks
measure: Cardiopulmonary exercise function test
timeFrame: 12 weeks
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
measure: Respiratory muscle force
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
measure: Quality of life questionnaire
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
measure: Quality of life questionnaire
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
measure: Quality of life questionnaire
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
measure: Quality of life questionnaire
timeFrame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Ching-Hsia Hung, Ph.D
role: STUDY_CHAIR
References: