UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041247 |
|---|---|
| Receipt number | 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 13:12:01 |
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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
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
j-okamoto@yosieikai.com
Sponsor or person
Institute
Tokyo Chidori Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047096
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