UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043762 |
|---|---|
| Receipt number | R000049957 |
| Scientific Title | Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/10/01 19:01:13 |
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Basic information
Public title
Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Acronym
Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Scientific Title
Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Scientific Title:Acronym
Effectiveness of goal setting to increase physical activity in chronic stroke patients with reduced walking ability
Region
| Japan |
Condition
Condition
cerebral vascular disease
Classification by specialty
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of goal setting for increasing physical activity in chronic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of physical activity(Sitting time, standing time, walking time, number of transitions from sitting to standing)
Key secondary outcomes
Vitality Index
SCI Exercise Self-Efficacy Scale
Kessler Psychological Distress Scale
Multidimensional Health Locus of Control scales
EQ-5D-5L
Functional Ambulation Classification
Gait speed
6 Minute Walk Test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to the usual individual functional training, a 10 minute period is set aside to provide feedback on the amount of physical activity of each subject and to set additional goals for the amount of physical activity.The intervention period is 2 weeks.
Interventions/Control_2
In addition to the usual individual functional training, a 10 minute period is set aside to practice rising movements and to provide additional instruction on rising movements as self-training.The intervention period is 2 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients who use day-care rehabilitation
Key exclusion criteria
Those who have difficulty in walking even with assistance.
Severe higher brain dysfunction, cognitive decline (MMSE score of 23 or below).
Those who have difficulty in listening by questionnaire.
Those who are judged by the physician to be inappropriate for participation in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Shibuya |
Organization
Hashimoto Hospital
Division name
Hashimoto Rehabilitation Clinic Rehabilitation Dept
Zip code
770-0813
Address
3-19-3 Nakajousanjima-cho,Tokushima-city,Tokushima
TEL
088-626-0311
mttk.0317@gmail.com
Public contact
Name of contact person
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Shibuya |
Organization
Hashimoto Hospital
Division name
Hashimoto Rehabilitation Clinic Rehabilitation Dept
Zip code
770-0813
Address
3-19-3 Nakajousanjima-cho,Tokushima-city,Tokushima
TEL
088-626-0311
Homepage URL
mttk.0317@gmail.com
Sponsor or person
Institute
Hashimoto Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Kibi International University for Research Screening
Address
8 Iga-machi, Takahashi, Okayama prefecture
Tel
0866-22-9472
k_harada@kiui.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
橋本リハビリテーションクリニック（徳島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049957
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049957
Number of participants that the trial has enrolled
12
Results
Regarding the amount of physical activity per day (24h=1440min) in both groups before and after the intervention, the main effects were observed in the group that received instruction on getting up and moving around on the number of times they sat for more than 30 minutes, the total time they sat for more than 30 minutes, and the total time they sat for more than 60 minutes before and after the intervention.
Results date posted
| 2024 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted on people with stroke who were using day rehabilitation services. The study was explained in writing and verbally, and measurements and interventions were started for those who provided written consent.
Participant flow
Of the 23 stroke patients who used outpatient rehabilitation, 15 were included in the study after 8 were excluded based on the exclusion criteria. Furthermore, 1 of these patients was hospitalized and 2 were excluded because they did not consent to wear an activity meter, so a total of 12 stroke patients were included in the analysis.
Adverse events
None
Outcome measures
Time spent lying down and time spent sitting
Number of times spent sitting for 30 minutes or more
Total time spent sitting for 30 minutes or more
Time spent standing and walking
Number of times getting up
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049957
