NCT06085261

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

August 6, 2023

Last Update Submit

October 13, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDpulmonary rehabilitationtele-rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk distance (6MWD)

    6-minute walk distance

    8 weeks; 20 weeks

Secondary Outcomes (13)

  • pulmonary function

    8 weeks; 20 weeks

  • pulmonary function

    8 weeks; 20 weeks

  • pulmonary function

    8 weeks; 20 weeks

  • pulmonary function

    8 weeks; 20 weeks

  • pulmonary function

    8 weeks; 20 weeks

  • +8 more secondary outcomes

Study Arms (2)

home-based telerehabilitation

EXPERIMENTAL

Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises.

Behavioral: home-based telerehabilitation group

center-based traditional rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: center-based traditional rehabilitation group

Interventions

home-based telerehabilitation groupBEHAVIORAL

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.

home-based telerehabilitation
center-based traditional rehabilitation groupBEHAVIORAL

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.

center-based traditional rehabilitation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Certain comorbidities (e.g. unstable coronary complications)
  • Severe cognitive disabilities (e.g. dementia)
  • Inability to cope with the program because of severe hearing or visual disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shiwei Qumu, Dr

    China-Japan Friendship Hospital

    STUDY DIRECTOR

Central Study Contacts

Ting Yang, MD

CONTACT

84206272zryyyangting@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

October 16, 2023

Study Start

November 1, 2023

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations

CN(1)