UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027650 |
|---|---|
| Receipt number | R000031317 |
| Scientific Title | Effect of respiratory rehabilitation for frail older patients with musculoskeletal disorders: a randomized controlled trial |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2019/08/09 16:03:16 |
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Basic information
Public title
Effect of respiratory rehabilitation for frail older patients with musculoskeletal disorders: a randomized controlled trial
Acronym
Effect of respiratory rehabilitation for frail older patients with musculoskeletal disorders
Scientific Title
Effect of respiratory rehabilitation for frail older patients with musculoskeletal disorders: a randomized controlled trial
Scientific Title:Acronym
Effect of respiratory rehabilitation for frail older patients with musculoskeletal disorders
Region
| Japan |
Condition
Condition
musculoskeletal disorders
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of respiratory rehabilitation on the respiratory function, swallowing function in community-dwelling frail older patients with musculoskeletal disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory function,after six weeks
Key secondary outcomes
swallowing function, exercise tolerance, six-minute walk distance, thorax flexibility, muscle strength grip and abdominal, adl and qol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rehabilitation sessions that included respiratory rehabilitation
two sessions a week, for 6 weeks.
Interventions/Control_2
typical rehabilitation
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
| 65 | years-old | <= |
Age-upper limit
| 94 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with musculoskeletal disorders; older persons certified as requiring support level or care leve,6 months since acute disease onset; Mini-Mental State Examination (MMSE) score over 21, absence of COPD or any other respiratory disease, and forced expiratory volume in 1 second (FEV1) of > 70.
Key exclusion criteria
moderate or severe cardiac disease (New York Heart Association Classification of III or IV), ischemic or hemorrhagic stroke, or neurodegenerative disease.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Yanagi |
Organization
University of Tsukuba
Division name
Department of Medical Science and Welfare, Faculty of Medicine
Zip code
305-8575
Address
Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan
TEL
029-853-3496
hyanagi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Maki |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
3050816
Address
Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan
TEL
080-2078-7135
Homepage URL
naoki19760917@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Department of Medical Science and Welfare, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Department of Medical Science and Welfare, Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan
Tel
0298533288
maki.naoki.ka@u.tsukuba.ac.jp
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
| 2017 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031317
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031317
Number of participants that the trial has enrolled
27
Results
The intervention group showed significantly greater improvement than the control group in the forced expiratory volume in 1 second, maximal expiratory mouth pressure and maximal inspiratory mouth pressure, cough peak flow, the range of motion of thoracolumbar spine rotation, the 6-minute walk test, the Dysphagia Risk Assessment for the Community-Dwelling Elderly test, the Medical Outcome Study 8-Item Short-Form Health Survey a physical component summary score.
Results date posted
| 2019 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with musculoskeletal disorders such as osteoarthritis and fracture older persons certified as requiring care.
Participant flow
a total of 67 patients completed the study, and 31 of them completed the respiratory rehabilitation program. No differences in patient characteristics or baseline clinical data were observed between the 2 groups (Table 1). The secondary measures did not differ between the 2 groups.
Adverse events
None
Outcome measures
Primary outcome measures were as follows: respiratory function and swallowing function. Secondary outcome measures were as follows: exercise tolerance, 6-minute walk distance, thorax flexibility, muscle strength (grip and abdominal), ADL, and QOL.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031317
