UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040079 |
|---|---|
| Receipt number | R000045633 |
| Scientific Title | Effects of intensive exercise on cognitive dysfunction in patients with pure cerebellar degeneration: a single-arm pilot study |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2021/11/09 18:24:14 |
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Basic information
Public title
Effects of rehabilitation on cognitive dysfunction in spinocerebellar degeneration
Acronym
Examination of rehabilitation effect of spinocerebellar degeneration
Scientific Title
Effects of intensive exercise on cognitive dysfunction in patients with pure cerebellar degeneration: a single-arm pilot study
Scientific Title:Acronym
Effect of exercise on cognitive dysfunction in SCD
Region
| Japan |
Condition
Condition
spinocerebellar degeneration
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether rehabilitation is effective for cognitive dysfunction in spinocerebellar degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function evaluation
Evaluate before intervention and after 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
4 weeks of rehabilitation
6 times a week
3 hours a day rehabilitation
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with spinocerebellar degeneration
Key exclusion criteria
Exclusion criteria included history of stroke, depression, complications including severe infection, deep vein thrombosis, orthopedic diseases causing pain during gait, unstable angina and cardiopulmonary disease causing dyspnea during exercise, and recent history of surgical intervention, including coronary artery bypass graft.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Shimamoto |
Organization
kumamoto southern regional hospital
Division name
department of rehabilitation
Zip code
861-4214
Address
mu-banchi mainohara jhonan-machi minami-ku kumamoto
TEL
0964-28-2555
sentyoukansetu@icloud.com
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Shimamoto |
Organization
kumamoto southern regional hospital
Division name
department of rehabilitation
Zip code
861-4214
Address
mu-banchi mainohara jhonan-machi minami-ku kumamoto
TEL
0964-28-2555
Homepage URL
sentyoukansetu@icloud.com
Sponsor or person
Institute
kumamoto southern regional hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000045633
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000045633
Number of participants that the trial has enrolled
16
Results
Motor function and ADL
SARA scores significantly improved from 10.7 to 8.1 points after exercise. BBS scores significantly increased from 43.6 to 48.8 points after exercise. FIM scores significantly increased from 119.7 to 122.3 points after exercise.
Cognitive function
MMSE scores significantly improved from 27.7 to 29.0 points after exercise. FAB scores significantly increased from 14.8 to 15.8 points after exercise. MoCA-J scores significantly increased from 24.6 to 26.7 points after exercise.
Results date posted
| 2021 | Year | 10 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We enrolled patients diagnosed with SCD of the purely cerebellar type, identified by an expert neurologist based on the results of DNA analysis. Patients had to be capable of independent activities of daily living and walking in order to be eligible for the study. Exclusion criteria included any abnormalities other than those within the cerebellum on magnetic resonance imaging and voxel based specific regional analysis system for Alzheimer disease, muscle weakness, marked range of motion limitation, sensory deficits including superficial deep sensation, vestibular dysfunction, motor dysfunction due to other diseases, and mental illness.
Participant flow
This study was a comparative study with a control group for the assessment of cognitive function, but a single-arm pilot study with only an intervention group and no comparison group for the assessment after the exercise intervention. Each participant in the control group underwent cognitive function tests. Participants in the patient group underwent cognitive and motor function and ADL assessments on admission. The same assessments were then performed again after intensive exercise therapy to evaluate the effect of exercise.
Adverse events
No adverse events were observed.
Outcome measures
Evaluation of motor function and ADL
1) Scale for the Assessment and Rating of Ataxia (SARA)
2) Berg Balance Scale (BBS)
3) Functional Independence Measure (FIM).
Evaluation of cognitive function
1) Mini-Mental State Examination (MMSE)
2) Frontal Assessment Battery (FAB)
3) Montreal Cognitive Assessment-Japanese (MoCA-J).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045633
