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Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia

This study has been completed.
Information provided by:
Hiroshima University Identifier:
First received: March 20, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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.

Condition Intervention Phase
Device: Speed-feedback therapy system with a bicycle ergometer
Device: Ergometer at conventional settings
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Hiroshima University:

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

Estimated Enrollment: 120
Study Start Date: September 2005
Study Completion Date: December 2006
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).

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00450047

Sponsors and Collaborators
Hiroshima University
Study Director: Hitoshi Okamura, MD, PhD Graduate School of Health Sciences, Hiroshima University
  More Information Identifier: NCT00450047     History of Changes
Other Study ID Numbers: 0662
Study First Received: March 20, 2007
Last Updated: March 20, 2007

Keywords provided by Hiroshima University:
cognitive impairment, ergometer, speed-feedback therapy

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors processed this record on April 26, 2017