NCT05832814

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 COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. Music therapy, such as rhythm-guided endurance training, singing training, listening to melody, may be one such potential relevant and motivating rehabilitation activity. The study aims to investigate the effects of home-based PR program with a rhythm-guided endurance walking exercise and singing training on both physiological and psychological aspects. Effects will be investigated in a randomized controlled trial (RCT) with 12-week intervention period.

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
75

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

July 31, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

July 31, 2022

Last Update Submit

October 9, 2023

Conditions

Keywords

COPDmusic therapypulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • incremental shuttle walking test(ISWT) distance

    incremental shuttle walking test distance

    12 weeks

Secondary Outcomes (9)

  • Respiratory muscle strength

    12 weeks

  • Spirometry

    12 weeks

  • Short Physical Performance Battery(SPPB)

    12 weeks

  • modified British medical research council(mMRC)

    12 weeks

  • COPD assessment test(CAT)

    12 weeks

  • +4 more secondary outcomes

Study Arms (3)

Integrated training

EXPERIMENTAL

Rhythm-guided walking exercise coordinated with singing training as training activity in pulmonary rehabilitation: 12 weeks, three times a week for 1 hour, leading to a total of 36 sessions

Behavioral: Integrated training

Rhythm-guided exercise training

EXPERIMENTAL

Rhythm-guided walking exercise as training activity in pulmonary rehabilitation: 12 weeks, three times a week for 1/2 hour, leading to a total of 36 sessions

Behavioral: Rhythm-guided exercise training

Usual care

NO INTERVENTION

The usual care is the comparator in the trial, consisting of standard medical treatment and educational sessions including physical training, smoking cessation and vaccination. And after the trial, the patients in this group will also be offered standard pulmonary rehabilitation according to the national guideline.

Interventions

For rhythm-guided walking exercise, the home exercise intensity, that is, the walking speed can be prescribed based on the incremental shuttle walking(ISWT) result. A rhythm matching with the walking speed can be calculated. Then patients will be provided a group of melodies identified by the calculated rhythm, which are also popular with the elder. During exercise, the patients are required to walking on a fixed speed identical with the rhythm. For singing training, patients follow the audios and videos to take training at home, which are recorded by singing teachers and physiotherapists prior to the trial. Each session includes technical instructions in order to achieve better respiratory control during singing.

Integrated training

For rhythm-guided walking exercise, the home exercise intensity, that is, the walking speed can be prescribed based on the incremental shuttle walking test(ISWT) result. A rhythm matching with the walking speed can be calculated. Then patients will be provided a group of melodies identified by the calculated rhythm, which are also popular with the elder. During exercise, the patients are required to walking on a fixed speed identical with the rhythm.

Rhythm-guided exercise training

Eligibility Criteria

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

You may qualify if:

  • Participants with a clinical diagnosis of COPD and meeting the following criteria are eligible:
  • Diagnosis of GOLD II-IV and without acute exacerbation within the last 4 weeks.
  • Motivated for participating in the project (and acceptance of randomization)
  • Sufficient mobility to attend PR

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.
  • No previous singing experience or musical competence is required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • Shi M, Yang L, Qumu S, Lei J, Huang K, He R, Niu H, Dong F, Wang S, He J, Yang T. Efficacy and safety of a music-therapy facilitated pulmonary telerehabilitation program in COPD patients: the COPDMELODY study protocol. Front Med (Lausanne). 2024 Mar 8;11:1361053. doi: 10.3389/fmed.2024.1361053. eCollection 2024.

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

  • Minghui Shi, MSc

    China-Japan Friendship Hospital

    STUDY DIRECTOR

Central Study Contacts

Ting Yang, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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

July 31, 2022

First Posted

April 27, 2023

Study Start

February 3, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations