Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Speed-feedback therapy system with a bicycle ergometer
Ergometer at conventional settings
Sponsored by

About this trial
This is an interventional treatment trial for Dementia focused on measuring cognitive impairment, ergometer, speed-feedback therapy
Eligibility Criteria
Inclusion Criteria:
- 65 years of age or older
- Diagnosed with dementia by a physician
- Mini-Mental State Examination score of 23 points or less
- Capable of participating at least once a week for 6 weeks in succession
Exclusion Criteria:
- Management of a medical risk required
- Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis
- Never having been on a bicycle, and incapable of pedaling well
Sites / Locations
Outcomes
Primary Outcome Measures
score on a scale of cognitive function immediately after completion of the 6-week intervention and 1 month after completion of the intervention
Secondary Outcome Measures
attentiveness score immediately after completion of the intervention, and score on an ADL scale and a QOL scale immediately after completion of the intervention and 1 month after completion of the intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00450047
Brief Title
Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia
Official Title
Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hiroshima University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.
Detailed Description
Dementia is a syndrome caused by diseases of the cerebral parenchyma, and it is a state in which cognitive functions, including attention, memory, thinking, comprehension, judgment, and computation, are diminished. Because of the mental symptoms, problem behaviors, and decreased activities of daily living (ADL) it is also recognized as a major social problem. However, rehabilitation of elderly people with dementia is still at the trial-and-error stage, and establishing a method of rehabilitation is an urgent task. In 2004, the authors devised and created a training method that integrates exercise therapy with feedback therapy to treat the cognitive dysfunction of elderly people with dementia. To do so the authors introduced speed-feedback therapy with a bicycle ergometer as a feedback therapy intervention. The results of a preliminary study of the efficacy of this method in improving cognitive dysfunction in 17 elderly persons with dementia showed improvement in cognitive dysfunction, and their attentiveness also improved, suggesting that the impaired attentiveness may have improved in response to treatment by this method and, as a result, have led to improvement of cognitive dysfunction. However, it became clear that it would be necessary to further improve and develop the system, and to demonstrate its efficacy in a controlled trial and verify associations between improvement of cognitive dysfunction and improvement of the ADL of dementia patients and their quality of life (QOL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
cognitive impairment, ergometer, speed-feedback therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Speed-feedback therapy system with a bicycle ergometer
Intervention Type
Device
Intervention Name(s)
Ergometer at conventional settings
Primary Outcome Measure Information:
Title
score on a scale of cognitive function immediately after completion of the 6-week intervention and 1 month after completion of the intervention
Secondary Outcome Measure Information:
Title
attentiveness score immediately after completion of the intervention, and score on an ADL scale and a QOL scale immediately after completion of the intervention and 1 month after completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65 years of age or older
Diagnosed with dementia by a physician
Mini-Mental State Examination score of 23 points or less
Capable of participating at least once a week for 6 weeks in succession
Exclusion Criteria:
Management of a medical risk required
Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis
Never having been on a bicycle, and incapable of pedaling well
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitoshi Okamura, MD, PhD
Organizational Affiliation
Graduate School of Health Sciences, Hiroshima University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia
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