UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053176 |
|---|---|
| Receipt number | R000060685 |
| Scientific Title | Effectiveness of home-based exercise therapy using remotely controlled cycling exercise system in patients with mild cognitive impairment due to non-Alzheimer's disease. |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2023/12/20 15:19:18 |
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Basic information
Public title
Effectiveness of home-based exercise therapy using remotely controlled cycling exercise system in patients with mild cognitive impairment due to non-Alzheimer's disease.
Acronym
Effectiveness of remotely controlled cycling exercise system in patients with mild cognitive impairment due to non-Alzheimer's disease.
Scientific Title
Effectiveness of home-based exercise therapy using remotely controlled cycling exercise system in patients with mild cognitive impairment due to non-Alzheimer's disease.
Scientific Title:Acronym
Effectiveness of remotely controlled cycling exercise system in patients with mild cognitive impairment due to non-Alzheimer's disease.
Region
| Japan |
Condition
Condition
Mild cognitive impairment due to non-Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the efficacy of disease-modifying drugs in Alzheimer's disease has recently been confirmed, an effective treatment has not yet been established for patients with mild cognitive impairment in non-Alzheimer's disease. We will examine whether exercise therapy using remotely controlled cycling exercise system is effective in preventing progression to dementia and the exacerbation of clinical symptoms in those cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of progression to dementia after 1-year exercise therapy.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Study subjects will receive exercise therapy at home under remote supervision and management. As a general rule, this will be conducted three times a week in a year.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 65 years of age or older
(2) Patient is diagnosed with mild cognitive impairment after a visit to our outpatient neuropsychology clinic of the Department of Neurology and Psychiatry.
(3) CSF biomarkers or the results of amyloid PET scan indicate that the patient does not have Alzheimer's pathology.
(4) Having a family member living with them or a caregiver who can visit them.
Key exclusion criteria
(1) Patients who do not have or cannot establish a reliable Internet environment at home
(2) Patients for whom exercise therapy is considered contraindicated
(3) Patients who have difficulty pedaling the exercise bike used for exercise therapy due to other diseases or pain
(4) Patients who have difficulty operating the application due to visual or hearing impairment
(5) Patients who have had hypotension, fatal arrhythmia, or other adverse events during rehabilitation, exercise stress tests, or exercise therapy
(6) Patients with acute myocardial infarction leaving untreated significant (>75%) coronary artery stenosis in [AHA classification: #1,2,3,5,6,7,11,13] in the major three branches
(7) Patients with end-stage heart failure
(8) Patients with evidence of residual myocardial ischemia
(9) Patients with poorly controlled heart failure
(10) Patients after implantation of left ventricular assist device
(11) Patients with a pacemaker, ICD, or implantable cardiac monitor
(12) Patients whose prognosis is expected to be within 6 months
(13) Patients who have participated in other clinical trials or clinical studies involving interventions within the past 12 weeks of obtaining consent
(14) Patients who are judged by the investigators to be incapable of properly understanding the significance of the research and complying with the compliance requirements.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University
Division name
Department of Pshiatry
Zip code
5650871
Address
D3, 2-2, yamadaoka, Suita-shi, Osaka, Japan
TEL
0668793051
suehiro-takashi@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka University
Division name
Department of Psychiatry
Zip code
5650871
Address
D3, 2-2, yamadaoka, Suita-shi, Osaka, Japan
TEL
0668793051
Homepage URL
suehiro-takashi@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
Osaka University Hospital ethical review board
Address
2-2, yamadaoka, suita-shi, Osaka, Japan
Tel
0662108289
rinri@hp-crc.med.osaka-u.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
| 2024 | Year | 01 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060685
