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Tele-based Resisted Exercise for COPD

Not Applicable
Completed
Conditions
COPD
Telerehabilitation
Pulmonary Rehabilitation
Cardiopulmonary Exercise Test
Compliance, Patient
Interventions
Other: Education
Other: Video-based pulmonary rehabilitation
Other: Booklet-based pulmonary rehabilitation
Registration Number
NCT04870632
Lead Sponsor
National Cheng-Kung University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control groupEducationPatients in control group received the education booklet with words and pictures.
Video groupVideo-based pulmonary rehabilitationPatients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.
Booklet groupBooklet-based pulmonary rehabilitationPatients in intervention group read education booklet with words and pictures to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.
Primary Outcome Measures
NameTimeMethod
Change of VO2max from 6th week to 12th weekFrom 6th week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 6th week(intervention ends) to 12th week(follow up ends)

Time point difference of AT from 6th week to 12th weekFrom 6th week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of time point of AT from 6th week(intervention ends) to 12th week(follow up ends)

Change of maximal exercise work from 1st week to 6th weekFrom 1st week to 6th week

Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to 6th week(intervention ends)

Change of maximal exercise work from 6th week to 12th weekFrom 6th week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 6th week(intervention ends) to 12th week(follow up ends)

Change of VO2max from 1st week to 12th weekFrom 1st week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 12th week(follow up ends)

Change of VE/VCO2 from 6th week to 12th weekFrom 6th week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 6th week(intervention ends) to 12th week(follow up ends)

Change of 6-minute walk test from 1st week to 6th weekFrom 1st week to 6th week

Measure the change of 6-minute walk test from 1st(intervention starts) week to 6th week(intervention ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.

Time point difference of AT from 1st week to 6th weekFrom 1st week to 6th week

Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 6th week(intervention ends)

Change of VE/VCO2 from 1st week to 6th weekFrom 1st week to 6th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 6th week(intervention ends)

Change of VE/VCO2 from 1st week to 12th weekFrom 1st week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 12th week(follow up ends)

Change of muscle strength from 1st week to 12th weekFrom 1st week to 12th week

Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)

Time point difference of AT from 1st week to 12th weekFrom 1st week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 12th week(follow up ends)

Change of maximal exercise work from 1st week to 12th weekFrom 1st week to 12th week

Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to to 12th week(follow up ends)

Change of VO2max from 1st week to 6th weekFrom 1st week to 6th week

Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 6th week(intervention ends)

Change of muscle strength from 1st week to 6th weekFrom 1st week to 6th week

Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 6th week(intervention ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)

Change of 6-minute walk test from 1st week to 12th weekFrom 1st week to 12th week

Measure the change of 6-minute walk test from 1st(intervention starts) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.

Change of muscle strength from 6th week to 12th weekFrom 6th week to 12th week

Use dynamometer to measure the changes of muscle strength(kg) from 6th week(intervention ends) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)

Change of 6-minute walk test from 6th week to 12th weekFrom 6th week to 12th week

Measure the change of 6-minute walk test from 6th(intervention ends) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.

Attendance rate in video group or booklet groupFrom 1st week to 6th week

If the patient completes 70% or more of the intervention program by being analyzed from the record of RPE form, he/she will be recognize as being completed the intervention.Finally, we will count the number of the patients who completed the intervention to be divided by the number of totally patients in video/booklet group at 6th week.

Secondary Outcome Measures
NameTimeMethod
FEV1Baseline, 6 weeks later, and 12 weeks later

Use spirometry to measure the values of FEV1 (%) for 3 times.The highest result will be recored.

FEV1/FVCBaseline, 6 weeks later, and 12 weeks later

Use spirometry to measure the values of FEV1/FVC for 3 times.The highest result will be recored.

Modified Medical Research Council (mMRC)Baseline, 6 weeks later, and 12 weeks later

Level of Modified Medical Research Council (mMRC)

EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)Baseline, 6 weeks later, and 12 weeks later

Score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Clinical COPD Questionnaires (CCQ)Baseline, 6 weeks later, and 12 weeks later

Score of Clinical COPD Questionnaires (CCQ)

COPD Assessment Test (CAT)Baseline, 6 weeks later, and 12 weeks later

Total score of COPD Assessment Test (CAT)

Trial Locations

Locations (1)

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

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