NCT04880486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

April 14, 2021

Last Update Submit

June 9, 2022

Conditions

COPDCOPD ExacerbationPulmonary RehabilitationWeight TrainingVirtual RealityMuscle StrengthPulmonary FunctionQuality of LifeReadmission

Keywords

Acute exacerbation of chronic obstructive pulmonary diseaseupper extremity weight trainingvirtual realityexercise capacityfunctional capacityadherence rate of exercise

Outcome Measures

Primary Outcomes (8)

  • Muscle Strength

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

    baseline

  • Muscle Strength

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

    4 weeks

  • Muscle Strength

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

    8 weeks

  • Muscle Strength

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

    12 weeks

  • Cardiopulmonary exercise function test

    using CPET to test for the maximal exercise performance of participant

    baseline

  • Cardiopulmonary exercise function test

    using CPET to test for the maximal exercise performance of participant

    4 weeks

  • Cardiopulmonary exercise function test

    using CPET to test for the maximal exercise performance of participant

    8 weeks

  • Cardiopulmonary exercise function test

    using CPET to test for the maximal exercise performance of participant

    12 weeks

Secondary Outcomes (6)

  • Pulmonary function test

    4 times (baseline, 4 weeks, 8 weeks, 12 weeks)

  • Respiratory muscle force

    4 times (baseline, 4 weeks, 8 weeks, 12 weeks)

  • Quality of life questionnaire

    4 times (baseline, 4 weeks, 8 weeks, 12 weeks)

  • Quality of life questionnaire

    4 times (baseline, 4 weeks, 8 weeks, 12 weeks)

  • Quality of life questionnaire

    4 times (baseline, 4 weeks, 8 weeks, 12 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Control group

SHAM COMPARATOR

usually care with extra health education on upper limb exercise

Other: Education

Exercise group

EXPERIMENTAL

usually care with extra supervision upper limb exercise with VR

Other: EducationOther: Supervision upper limb weight training exercise with VR

Interventions

EducationOTHER

Usual pulmonary rehabilitation education and pharmacological therapies, and taught them some limbs exercise, using social application to contact and suggestion giving as supervision.

Control groupExercise group
Supervision upper limb weight training exercise with VROTHER

Participant is supervised by physical therapist to conduct upper limb weight training exercise with VR.

Exercise group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ching-Hsia Hung, Ph.D

    National Cheng-Kung University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2021

First Posted

May 10, 2021

Study Start

September 18, 2019

Primary Completion

January 17, 2021

Study Completion

August 31, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations

TW(1)