COPD: A Multi-center Supervised Tele-rehabilitation Study

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: center-based traditional rehabilitation group; Behavioral: home-based telerehabilitation group

• Registration Number: NCT06085261
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-06
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16
• Study Start: 2023-11
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
center-based traditional rehabilitation	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.
home-based telerehabilitation	home-based telerehabilitation group	Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises.

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD)	8 weeks; 20 weeks	6-minute walk distance

Secondary Outcome Measures

Name	Time	Method
pulmonary function	8 weeks; 20 weeks	diffusing capacity of the lung for carbon monoxide (DLCO) \[velocity\]
Short Physical Performance Battery(SPPB)	8 weeks; 20 weeks	Test for health-related physical performance
COPD assessment test(CAT)	8 weeks; 20 weeks	It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.
modified British medical research council(mMRC)	8 weeks; 20 weeks	It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.
Respiratory muscle strength	8 weeks; 20 weeks	maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)
St. George's Respiratory Questionnaire (SGRQ)	8 weeks; 20 weeks	It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.
Hospital Anxiety and Depression Scale(HADS)	8 weeks; 20 weeks	It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.

Trial Locations

Locations (1)

China-Japan Friendship hospital; 🇨🇳 Beijing, China