NCT04870632

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 2, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

April 14, 2021

Last Update Submit

July 18, 2024

Conditions

COPDPulmonary RehabilitationTelerehabilitationCardiopulmonary Exercise TestCompliance, Patient

Keywords

COPDPulmonary RehabilitationTelerehabilitationVideo-based telerehabilitationYoutubeLINEBooklet-based telerehabilitationCardiopulmonary exercise testInterval strengthening exercisesCellphone

Outcome Measures

Primary Outcomes (19)

  • Time point difference of AT 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)

    From 1st week to 6th week

  • Time point difference of AT 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)

    From 1st week to 12th week

  • Time point difference of AT 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)

    From 6th week to 12th week

  • Change of maximal exercise work 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)

    From 1st week to 6th week

  • Change of maximal exercise work 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)

    From 1st week to 12th week

  • Change of maximal exercise work 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)

    From 6th week to 12th week

  • Change of VO2max 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)

    From 1st week to 6th week

  • Change of VO2max 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)

    From 1st week to 12th week

  • Change of VO2max 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)

    From 6th week to 12th week

  • Change of VE/VCO2 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)

    From 1st week to 6th week

  • Change of VE/VCO2 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)

    From 1st week to 12th week

  • Change of VE/VCO2 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)

    From 6th week to 12th week

  • Change of muscle strength 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)

    From 1st week to 6th week

  • Change of muscle strength 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)

    From 1st week to 12th week

  • Change of muscle strength 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)

    From 6th week to 12th week

  • Change of 6-minute walk test 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.

    From 1st week to 6th week

  • Change of 6-minute walk test 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.

    From 1st week to 12th week

  • Change of 6-minute walk test 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.

    From 6th week to 12th week

  • Attendance rate in video group or booklet group

    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.

    From 1st week to 6th week

Secondary Outcomes (6)

  • 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

  • COPD Assessment Test (CAT)

    Baseline, 6 weeks later, and 12 weeks later

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

    Baseline, 6 weeks later, and 12 weeks later

  • +1 more secondary outcomes

Study Arms (3)

Control group

SHAM COMPARATOR

Patients in control group received the education booklet with words and pictures.

Other: Education

Video group

EXPERIMENTAL

Patients 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.

Other: Video-based pulmonary rehabilitation

Booklet group

EXPERIMENTAL

Patients 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.

Other: Booklet-based pulmonary rehabilitation

Interventions

EducationOTHER

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

Control group
Video-based pulmonary rehabilitationOTHER

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.

Video group
Booklet-based pulmonary rehabilitationOTHER

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.

Booklet group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 ObstructivePatient Compliance

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

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
NON 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 3, 2021

Study Start

March 2, 2020

Primary Completion

May 31, 2021

Study Completion

July 10, 2021

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)