UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041247
Receipt No. R000047096
Scientific Title Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2020/07/29
Last modified on 2020/10/04 (Ver. 3)

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Basic information
Public title Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease
Acronym Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease
Scientific Title Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym Combined effect of pulmonary rehabilitation and music therapy in patients with chronic obstructive pulmonary disease
Region
Japan

Condition
Condition COPD
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess improvements in parameters of lung function and physiological, psychological, and physical factors in patients with COPD receiving music therapy and pulmonary rehabilitation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 6MWD
Key secondary outcomes age
BMI
mMRC
Borg scale
CAT
SDS
STAI
GSES
Spirometer
NRADL

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The PR program lasted 40 min and consisted of respiratory muscle training, strength training, and endurance training for 10 min each. Figure 1 shows a participant in the PR program. The MT program lasted 20 min. Vocalization practice was performed with the aim of increasing voice volume, expanding range, improving sound, and extending the duration of vocalizations. The practice first used a song with a short breath interval, and the timing was then adjusted. Exhalation practice with the keyboard harmonica maintained exhalation at a rhythm of every three beats with one note, gradually increasing the number of beats. The level of difficulty increased from simple songs to Japanese ballads and popular songs that varied greatly in song length and associated sounds. For the study procedures, the PR group performed 40 min of the PR program and 20 min of leisure activities while sitting, while the combination group participated in 40 min of the PR program and 20 min of the MT program. After four weeks, comparisons of data taken before and after the interventions were made. At that point, the patients in each group were exposed to a different intervention.
Interventions/Control_2 The PR program lasted 40 min and consisted of respiratory muscle training, strength training, and endurance training for 10 min each. Figure 1 shows a participant in the PR program. The MT program lasted 20 min. Vocalization practice was performed with the aim of increasing voice volume, expanding range, improving sound, and extending the duration of vocalizations. The practice first used a song with a short breath interval, and the timing was then adjusted. Exhalation practice with the keyboard harmonica maintained exhalation at a rhythm of every three beats with one note, gradually increasing the number of beats. The level of difficulty increased from simple songs to Japanese ballads and popular songs that varied greatly in song length and associated sounds. For the study procedures, the PR group performed 40 min of the PR program and 20 min of leisure activities while sitting, while the combination group participated in 40 min of the PR program and 20 min of the MT program. After four weeks, comparisons of data taken before and after the interventions were made. At that point, the patients in each group were exposed to a different intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients hospitalized and diagnosed with COPD were included. The patients with less than 70% of the FEV1.0/FVC ratio (FEV1.0%) who liked music were included.
Key exclusion criteria Patients with other airflow disorders, severe comorbidities, neuropathy, advanced dementia, severe mental illness, and unstable heart disease were excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Okamoto
Organization Tokyo Chidori Hospital
Division name Department of Rehabilitation
Zip code 146-0083
Address 2-39-10 Chidori, Ota-ku, Tokyo
TEL 0337582671
Email j-okamoto@yosieikai.com

Public contact
Name of contact person
1st name Jun
Middle name
Last name Okamoto
Organization Tokyo Chidori Hospital
Division name Department of Rehabilitation
Zip code 146-0083
Address 2-39-10 Chidori, Ota-ku, Tokyo
TEL 0337582671
Homepage URL
Email j-okamoto@yosieikai.com

Sponsor
Institute Tokyo Chidori Hospital
Institute
Department

Funding Source
Organization Tokyo Chidori Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Shimousa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Chidori Hospital
Address 2-39-10 Chidori, Ota-ku, Tokyo
Tel 0337582671
Email j-okamoto@yoshieikai.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 13
Results 
No significant differences were found in basic patient characteristics. As a result of two-way analysis of variance, interaction was observed at FEV1.0%. The simple main effect test showed a significant improvement in FEV1.0% in the MT combination group after the intervention. mMRC, 6MWD, and NRADL scores showed a significant main effect with time. No significant differences were observed in SDS, STAI, CAT, or GSES.
Results date posted
2020 Year 07 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 12 Month 06 Day
Date of IRB
2018 Year 12 Month 06 Day
Anticipated trial start date
2020 Year 07 Month 29 Day
Last follow-up date
2020 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 29 Day
Last modified on
2020 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047096