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临床试验/NCT04870632
NCT04870632已完成不适用

Six Weeks Tele-based Resistance Exercise Improves the Respiratory Muscle Strength and Biceps Strength Among Patients With Chronic Obstructive Pulmonary Disease

National Cheng-Kung University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change of VO2max from 6th week to 12th week

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change of VO2max from 6th week to 12th week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 week

时间窗: From 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 group

时间窗: From 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.

次要结局

  • FEV1(Baseline, 6 weeks later, and 12 weeks later)
  • FEV1/FVC(Baseline, 6 weeks later, and 12 weeks later)
  • Modified Medical Research Council (mMRC)(Baseline, 6 weeks later, and 12 weeks later)
  • EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)(Baseline, 6 weeks later, and 12 weeks later)
  • Clinical COPD Questionnaires (CCQ)(Baseline, 6 weeks later, and 12 weeks later)
  • COPD Assessment Test (CAT)(Baseline, 6 weeks later, and 12 weeks later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ching-Hsia Hung

Professor

National Cheng-Kung University Hospital

研究点 (2)

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