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

NCT ID: NCT00450047

Last Updated: 2007-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-12-31

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).

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Speed-feedback therapy system with a bicycle ergometer

Intervention Type: DEVICE

Ergometer at conventional settings

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hiroshima University

OTHER

Sponsor Role: lead

Principal Investigators

Hitoshi Okamura, MD, PhD

Role: STUDY_DIRECTOR

Graduate School of Health Sciences, Hiroshima University

Other Identifiers

0662

Identifier Type: -

Identifier Source: org_study_id