Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD, COPD Exacerbation, Pulmonary Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Education
Supervision upper limb weight training exercise with VR
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring Acute exacerbation of chronic obstructive pulmonary disease, upper extremity weight training, virtual reality, exercise capacity, functional capacity, adherence rate of exercise
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
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Exercise group
Arm Description
usually care with extra health education on upper limb exercise
usually care with extra supervision upper limb exercise with VR
Outcomes
Primary Outcome Measures
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Secondary Outcome Measures
Pulmonary function test
using spirometry to test for pulmonary function of participant FEV1/FVC in liter
Respiratory muscle force
using digital pressure Guage to test for inspiratory/expiratory muscle force of participant MIP/MEP in cmH2O
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
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;
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;
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;
Full Information
NCT ID
NCT04880486
First Posted
April 14, 2021
Last Updated
June 9, 2022
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04880486
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
January 17, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
usually care with extra health education on upper limb exercise
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
usually care with extra supervision upper limb exercise with VR
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Usual pulmonary rehabilitation education and pharmacological therapies, and taught them some limbs exercise, using social application to contact and suggestion giving as supervision.
Intervention Type
Other
Intervention Name(s)
Supervision upper limb weight training exercise with VR
Intervention Description
Participant is supervised by physical therapist to conduct upper limb weight training exercise with VR.
Primary Outcome Measure Information:
Title
Muscle Strength
Description
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Time Frame
baseline
Title
Muscle Strength
Description
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Time Frame
4 weeks
Title
Muscle Strength
Description
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Time Frame
8 weeks
Title
Muscle Strength
Description
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Time Frame
12 weeks
Title
Cardiopulmonary exercise function test
Description
using CPET to test for the maximal exercise performance of participant
Time Frame
baseline
Title
Cardiopulmonary exercise function test
Description
using CPET to test for the maximal exercise performance of participant
Time Frame
4 weeks
Title
Cardiopulmonary exercise function test
Description
using CPET to test for the maximal exercise performance of participant
Time Frame
8 weeks
Title
Cardiopulmonary exercise function test
Description
using CPET to test for the maximal exercise performance of participant
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pulmonary function test
Description
using spirometry to test for pulmonary function of participant FEV1/FVC in liter
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Title
Respiratory muscle force
Description
using digital pressure Guage to test for inspiratory/expiratory muscle force of participant MIP/MEP in cmH2O
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Title
Quality of life questionnaire
Description
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
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Title
Quality of life questionnaire
Description
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;
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Title
Quality of life questionnaire
Description
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;
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Title
Quality of life questionnaire
Description
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;
Time Frame
4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hsia Hung, Ph.D
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs