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Completed

NCT Number: NCT04870632

Tele-based Resisted Exercise for COPD

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.

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Key information

Conditions

COPD Behavior Cardiopulmonary Exercise Test Chronic Disease Compliance, Patient Disease Attributes Health Behavior Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Pulmonary Disease, Chronic Obstructive Pulmonary Rehabilitation Respiratory Tract Diseases Telerehabilitation Treatment Adherence and Compliance

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.

Video-based pulmonary rehabilitation

Other

COPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.

Booklet-based pulmonary rehabilitation

Other

COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.

Primary outcomes

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

    Time frame: 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)

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

    Time frame: 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)

  3. Time point difference of AT from 6th week to 12th week

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  7. Change of VO2max from 1st week to 6th week

    Time frame: 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)

  8. Change of VO2max from 1st week to 12th week

    Time frame: 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)

  9. Change of VO2max from 6th week to 12th week

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

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

    Time frame: 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)

  13. Change of muscle strength from 1st week to 6th week

    Time frame: 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)

  14. Change of muscle strength from 1st week to 12th week

    Time frame: 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)

  15. Change of muscle strength from 6th week to 12th week

    Time frame: 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)

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  19. Attendance rate in video group or booklet group

    Time frame: 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.

Secondary outcomes

  1. FEV1

    Time frame: Baseline, 6 weeks later, and 12 weeks later

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

  2. FEV1/FVC

    Time frame: Baseline, 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.

  3. Modified Medical Research Council (mMRC)

    Time frame: Baseline, 6 weeks later, and 12 weeks later

    Level of Modified Medical Research Council (mMRC)

  4. COPD Assessment Test (CAT)

    Time frame: Baseline, 6 weeks later, and 12 weeks later

    Total score of COPD Assessment Test (CAT)

  5. EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    Time frame: Baseline, 6 weeks later, and 12 weeks later

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

  6. Clinical COPD Questionnaires (CCQ)

    Time frame: Baseline, 6 weeks later, and 12 weeks later

    Score of Clinical COPD Questionnaires (CCQ)

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 3, 2021
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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