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Completed

NCT Number: NCT00450047

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speed-feedback therapy system with a bicycle ergometer

Device

Ergometer at conventional settings

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Registry information

Official study title

Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia: a Randomized Controlled Trial

Important dates

Study start
2005
Study completion
2006
First posted
Mar 21, 2007
Registry last updated
Mar 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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