COPDNCT04880486
Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Education and Supervision upper limb weight training exercise with VR in people with COPD and COPD Exacerbation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD, COPD Exacerbation, Pulmonary Rehabilitation
- What is being tested?
- Education and Supervision upper limb weight training exercise with VR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Sep 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalization due to acute exacerbation of chronic obstructive pulmonary disease in preceding 1-year history
- age was between 40 to 85 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COPD, COPD Exacerbation, Pulmonary Rehabilitation, Weight Training, Virtual Reality, Muscle Strength
- Being tested
- Education, Supervision upper limb weight training exercise with VR
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, upper extremity weight training, virtual reality, exercise capacity, functional capacity, adherence rate of exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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 VROther
Participant is supervised by physical therapist to conduct upper limb weight training exercise with VR.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | usually care with extra health education on upper limb exercise Receives: Other: Education |
| Exercise group | Experimental | usually care with extra supervision upper limb exercise with VR Receives: Other: Education; Other: Supervision upper limb weight training exercise with VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Measured: baseline
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Measured: 4 weeks
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Measured: 8 weeks
Muscle Strength
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Measured: 12 weeks
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Measured: baseline
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Measured: 4 weeks
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Measured: 8 weeks
Cardiopulmonary exercise function test
using CPET to test for the maximal exercise performance of participant
Measured: 12 weeks
Secondary outcomes (6)
Pulmonary function test
using spirometry to test for pulmonary function of participant FEV1/FVC in liter
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Respiratory muscle force
using digital pressure Guage to test for inspiratory/expiratory muscle force of participant MIP/MEP in cmH2O
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
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
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
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;
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
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;
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
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;
Measured: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start18 Sep 2019
- Primary completion17 Jan 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ching-Hsia Hung, National Cheng-Kung University Hospital
- Investigators
- Ching-Hsia Hung, Ph.D, Study chair, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880486
- Sponsor's protocol ID
- B-BR-108-038
- Status last verified
- Jun 2022
- First submitted
- 14 Apr 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04880486
- Acronym / sponsor ID
- B-BR-108-038
- Conditions
- COPD, COPD Exacerbation, Pulmonary Rehabilitation, Weight Training, Virtual Reality, Muscle Strength
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, upper extremity weight training, virtual reality, exercise capacity, functional capacity, adherence rate of exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Educationusually care with extra health education on upper limb exercise |
| Exercise group | Experimental | Other: Education, Other: Supervision upper limb weight training exercise with VRusually care with extra supervision upper limb exercise with VR |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hospitalization due to acute exacerbation of chronic obstructive pulmonary disease in preceding 1-year history
- age was between 40 to 85 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationUsual pulmonary rehabilitation education and pharmacological therapies, and taught them some limbs exercise, using social application to contact and suggestion giving as supervision. | Other | Control group, Exercise group |
| Supervision upper limb weight training exercise with VRParticipant is supervised by physical therapist to conduct upper limb weight training exercise with VR. | Other | Exercise group |
Primary outcome
Muscle Strength
Time frame: baseline
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
Time frame: 4 weeks
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
Time frame: 8 weeks
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Muscle Strength
Time frame: 12 weeks
using handhold dynamometer to test 5 motions for bilateral side for 3 times.
Cardiopulmonary exercise function test
Time frame: baseline
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
Time frame: 4 weeks
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
Time frame: 8 weeks
using CPET to test for the maximal exercise performance of participant
Cardiopulmonary exercise function test
Time frame: 12 weeks
using CPET to test for the maximal exercise performance of participant
6 secondary outcomes
Pulmonary function test
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Respiratory muscle force
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Quality of life questionnaire
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Quality of life questionnaire
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Quality of life questionnaire
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Quality of life questionnaire
Time frame: 4 times (baseline, 4 weeks, 8 weeks, 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Hsia Hung, Ph.D study chair
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Supervision upper limb weight training exercise with VR in people with COPD and COPD Exacerbation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.