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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450047
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
Information provided by:
Hiroshima University

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.

Condition or disease Intervention/treatment Phase
Dementia Device: Speed-feedback therapy system with a bicycle ergometer Device: Ergometer at conventional settings Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia: a Randomized Controlled Trial
Study Start Date : September 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450047

Sponsors and Collaborators
Hiroshima University
Study Director: Hitoshi Okamura, MD, PhD Graduate School of Health Sciences, Hiroshima University Identifier: NCT00450047     History of Changes
Other Study ID Numbers: 0662
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: March 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