UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037650 |
|---|---|
| Receipt number | R000042933 |
| Scientific Title | he effect of pulmonary training for community-dwelling frail elderly with chronic stroke: a randomized controlled pilot trial |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2019/08/09 15:34:39 |
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Basic information
Public title
he effect of pulmonary training for community-dwelling frail elderly with chronic stroke: a randomized controlled pilot trial
Acronym
he effect of pulmonary training for community-dwelling frail elderly with chronic stroke
Scientific Title
he effect of pulmonary training for community-dwelling frail elderly with chronic stroke: a randomized controlled pilot trial
Scientific Title:Acronym
he effect of pulmonary training for community-dwelling frail elderly with chronic stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effects of the pulmonary rehabilitation on the respiratory function, deglutition and QOL in community-dwelling frail elderly with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
respiratory function and swallowing function
Key secondary outcomes
exercise tolerance, 6-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
Cluster
Blinding
Open -no one is blinded
Control
Active
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
(1) respiratory muscle training, (2) cough exercise, (3) diaphragmatic muscle training (4) stretching exercise, (5) home exercise(2 sessions a week, for 4 weeks).
Each 20-minute session was held once a day and comprised 10 minutes of respiratory rehabilitation in addition to 10 minutes of usual rehabilitation.
Interventions/Control_2
(1) range of motion exercise, (2) muscle strength training, (3) balance training, (4) gait training, but no respiratory 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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
persons certified as requiring support level or care level, 6 months since acute disease onset, Mini-Mental state Examination (MMSE) score less than 21
Key exclusion criteria
patients with moderate or severe cardiac disease (New York Heart Association Classification of III or IV)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Maki |
Organization
University of Tsukuba
Division name
Department of Thorasic Surgery, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3288
maki.naoki.ka@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Maki |
Organization
University of Tsukuba
Division name
Thorasic Surgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3288
Homepage URL
maki.naoki.ka@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
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
| 2019 | Year | 08 | Month | 19 | 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
27
Results
Results date posted
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | 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=R000042933
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
