COPD: A Multi-center Supervised Tele-rehabilitation Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPDMUST  

Official title:

Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06085261
• Other study ID #: 2021-I2M-1-409
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD
• Phone: 84206272
• Email: zryyyangting[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Participants with a clinical diagnosis of and meeting the following criteria are eligible:

1. Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.

2. Motivated for participating in the project (and acceptance of randomization)

3. Sufficient mobility to attend PR

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications)

2. Severe cognitive disabilities (e.g. dementia)

3. Inability to cope with the program because of severe hearing or visual disorder.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• home-based telerehabilitation group
Participants will download the web application in their smartphones in the hospital's outpatient clinic and learn to use the sports wristwatch. Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. The initial aerobic exercise prescription for walking will be set at 80% of the speed walked during a 6-minute walk test (6MWT) and progressed each 4-week according to patient assessments. Resistance training for the arms and legs will utilize elastic bands, while respiratory training will utilize portable breathing trainer. During each training session, participants will be asked to follow the videos in the web application, wearing the sports wristwatch recording their exercise intensity. At the end of every training session, training data could be uploaded to the web platform automatically, which will be checked by staff in hospital.
• center-based traditional rehabilitation group
Participants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment. The initial aerobic exercise prescription for cycling will be set at 60% of the peak oxygen uptake (VO2) on a cardiopulmonary exercise test (CPET). Resistance training and respiratory training are similar to the telerehabilitation group.

Locations

Country	Name	City	State
China	China-Japan Friendship hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk distance (6MWD)	6-minute walk distance	8 weeks; 20 weeks
Secondary	pulmonary function	forced expiratory volume in 1 second (FEV1) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	ratio between FEV1 and forced vital capacity (FEV1/FVC) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	inspiratory capacity (IC) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	residual volume (RV) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	total lung capacity (TLC) [velocity]	8 weeks; 20 weeks
Secondary	pulmonary function	diffusing capacity of the lung for carbon monoxide (DLCO) [velocity]	8 weeks; 20 weeks
Secondary	Respiratory muscle strength	maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)	8 weeks; 20 weeks
Secondary	Short Physical Performance Battery(SPPB)	Test for health-related physical performance	8 weeks; 20 weeks
Secondary	modified British medical research council(mMRC)	It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.	8 weeks; 20 weeks
Secondary	COPD assessment test(CAT)	It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.	8 weeks; 20 weeks
Secondary	St. George's Respiratory Questionnaire (SGRQ)	It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.	8 weeks; 20 weeks
Secondary	Hospital Anxiety and Depression Scale(HADS)	It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.	8 weeks; 20 weeks