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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
Hiroshima University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring cognitive impairment, ergometer, speed-feedback therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 65 years of age or older
  2. Diagnosed with dementia by a physician
  3. Mini-Mental State Examination score of 23 points or less
  4. Capable of participating at least once a week for 6 weeks in succession

Exclusion Criteria:

  1. Management of a medical risk required
  2. Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis
  3. 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

    First Posted
    March 20, 2007
    Last Updated
    March 20, 2007
    Sponsor
    Hiroshima University
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    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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