Clinical trial NCT04870632: Tele-based Resisted Exercise for COPD
Official title: Six Weeks Tele-based Resistance Exercise Improves the Respiratory Muscle Strength and Biceps Strength Among Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Pulmonary Rehabilitation
Telerehabilitation
Cardiopulmonary Exercise Test
Compliance, Patient
Keywords: COPD
Pulmonary Rehabilitation
Telerehabilitation
Video-based telerehabilitation
Youtube
LINE
Booklet-based telerehabilitation
Cardiopulmonary exercise test
Interval strengthening exercises
Cellphone
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to investigate the effect of six weeks tele-based resisted exercises on cardiopulmonary function, quality of life, muscle strength and functioanl performance among patients with chronic obstructive pulmonary disease. In addition, the effect of different forms of exercise instruction (i.e., booklet and video) was also investigated.

Detailed description: Background and Purpose: Chronic obstructive pulmonary disease (COPD) is the 3rd global cause of deaths. Pulmonary rehabilitation (PR) is the standard treatment for this disease. However, the dropout rate remains high (33-50%) because of traffic issues and patients' low mobility. Therefore, telerehabilitation seems to be a better way to deliver PR. Using videos to deliver PR is not only easy to manipulate on the cellphone or ipad, but also improve patients' attention and compliance. Thus, the aim of this study is to assess whether tailor-made PR video rehabilitation program improves patients' quality of life (QoL), muscle strengths, cardiopulmonary functions, and compliance.

Methods: This is a quasi-experimental study. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. They voluntarily choose to participate in control group, booklet group or video groups to conduct 6-week tele-based resisted exercise program. Patients in control group received conventional intervention and exercise instruction booklet. Participants in booklet and video groups additionally received a COPD exercise package with 2 elastic bands in different weight (4 ponds and 8 ponds). Participants in booklet group received the exercise instructed in education booklet with words and pictures. Patients in video group received exercise instructed using YouTube videos. Both participants in booklet and video groups were asked to record their rating of perceived exertion (RPE) scores. A physical therapist would weekly contact them to monitor and modify the exercise intensity using their RPE scores. The videos included 5-minute breathing reeducation, 20-minute interval strengthening exercise and 5-minute education animation. All patients were assessed the performance of spirometry, cardiopulmonary exercise test (CPET), questionnaires about symptoms, QoL, muscle strengths and distances of 6-minute walk test (6MWT) before intervention, after intervention and after 6-week follow-up.

Eligibility criteria: Inclusion Criteria:

* COPD
* Be medically stable
* Ability to use a smartphone and applications (LINE and Youtube)
* Access to the internet
* Have visual and auditory impairments corrected with assistive devices

Exclusion Criteria:

* Other respiratory disease as main complaint other than COPD
* Exacerbations within 4 weeks
* Had enrolled PR programs within the last 6 months
* Unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
* Unstable medical conditions
* Any comorbidities which precluded exercise training

Primary outcomes:
measure: Time point difference of AT from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Time point difference of AT from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Time point difference of AT from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Change of maximal exercise work from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Change of maximal exercise work from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Change of maximal exercise work from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Change of VO2max from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Change of VO2max from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Change of VO2max from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Change of VE/VCO2 from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Change of VE/VCO2 from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Change of VE/VCO2 from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Change of muscle strength from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Change of muscle strength from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Change of muscle strength from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Change of 6-minute walk test from 1st week to 6th week
timeFrame: From 1st week to 6th week
measure: Change of 6-minute walk test from 1st week to 12th week
timeFrame: From 1st week to 12th week
measure: Change of 6-minute walk test from 6th week to 12th week
timeFrame: From 6th week to 12th week
measure: Attendance rate in video group or booklet group
timeFrame: From 1st week to 6th week
Secondary outcomes:
measure: FEV1
timeFrame: Baseline, 6 weeks later, and 12 weeks later
measure: FEV1/FVC
timeFrame: Baseline, 6 weeks later, and 12 weeks later
measure: Modified Medical Research Council (mMRC)
timeFrame: Baseline, 6 weeks later, and 12 weeks later
measure: COPD Assessment Test (CAT)
timeFrame: Baseline, 6 weeks later, and 12 weeks later
measure: EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: Baseline, 6 weeks later, and 12 weeks later
measure: Clinical COPD Questionnaires (CCQ)
timeFrame: Baseline, 6 weeks later, and 12 weeks later
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: