Clinical trial NCT00450047: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia
Keywords: cognitive impairment, ergometer, speed-feedback therapy
Lead sponsor: Hiroshima University
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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:
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: Graduate School of Health Sciences, Hiroshima University
name: Hitoshi Okamura, MD, PhD
role: STUDY_DIRECTOR
References: