UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027650
Receipt No. 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 (Ver. 5)

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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
Email 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
Email naoki19760917@yahoo.co.jp

Sponsor
Institute University of Tsukuba
Department of Medical Science and Welfare, Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031317