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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04880486
Other study ID # B-BR-108-038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2019
Est. completion date August 31, 2021

Study information

Verified date June 2022
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date August 31, 2021
Est. primary completion date January 17, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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

Study Design


Intervention

Other:
Education
Usual pulmonary rehabilitation education and pharmacological therapies, and taught them some limbs exercise, using social application to contact and suggestion giving as supervision.
Supervision upper limb weight training exercise with VR
Participant is supervised by physical therapist to conduct upper limb weight training exercise with VR.

Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Strength using handhold dynamometer to test 5 motions for bilateral side for 3 times. baseline
Primary Muscle Strength using handhold dynamometer to test 5 motions for bilateral side for 3 times. 4 weeks
Primary Muscle Strength using handhold dynamometer to test 5 motions for bilateral side for 3 times. 8 weeks
Primary Muscle Strength using handhold dynamometer to test 5 motions for bilateral side for 3 times. 12 weeks
Primary Cardiopulmonary exercise function test using CPET to test for the maximal exercise performance of participant baseline
Primary Cardiopulmonary exercise function test using CPET to test for the maximal exercise performance of participant 4 weeks
Primary Cardiopulmonary exercise function test using CPET to test for the maximal exercise performance of participant 8 weeks
Primary Cardiopulmonary exercise function test using CPET to test for the maximal exercise performance of participant 12 weeks
Secondary Pulmonary function test using spirometry to test for pulmonary function of participant FEV1/FVC in liter 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Secondary Respiratory muscle force using digital pressure Guage to test for inspiratory/expiratory muscle force of participant MIP/MEP in cmH2O 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Secondary Quality of life questionnaire using questionnaires of EuroQol-5 Dimension (EQ-5D) to test for the quality of life of participant EuroQol-5 Dimension (EQ-5D): 5 levels of health status description to measure quality of life, a higher level means a worsen outcome 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Secondary Quality of life questionnaire using modified Medical Research Council dyspnea scale (mMRC) questionnaire to test for the chronic obstructive pulmonary disease symptom of participants
Modified Medical Research Council dyspnea scale (mMRC): score from 0-4 to measure the symptom severity of chronic obstructive pulmonary disease, a higher score means a worsen outcome;
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Secondary Quality of life questionnaire using chronic obstructive pulmonary disease assessment Test (CAT) questionnaire to test for the chronic obstructive pulmonary disease symptom of participants
chronic obstructive pulmonary disease assessment Test (CAT): score from 0-40 to measure the symptom severity of chronic obstructive pulmonary disease, a higher score means a worsen outcome;
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Secondary Quality of life questionnaire using clinical chronic obstructive pulmonary disease questionnaire (CCQ) to test for the chronic obstructive pulmonary disease symptom of participants
Clinical chronic obstructive pulmonary disease questionnaire (CCQ): score from 0-60 to measure the symptom severity of chronic obstructive pulmonary disease, a higher score means a worsen outcome;
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
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