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CompletedNCT00450047Updated Mar 21, 2007

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

A Phase 4 interventional study of Speed-feedback therapy system with a bicycle ergometer and Ergometer at conventional settings in Dementia, sponsored by Hiroshima University. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2007-03-21.

Sponsored by Hiroshima University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Dementia

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Keywords

  • cognitive impairment, ergometer, speed-feedback therapy
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 120 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Hiroshima University is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants

Interventions

  • DeviceSpeed-feedback therapy system with a bicycle ergometer
  • DeviceErgometer at conventional settings
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00450047
Lead sponsor
Hiroshima University
First posted
Mar 21, 2007
Start date
Sep 2005
Completion
Dec 2006
Last update
Mar 21, 2007

Study contacts

Hitoshi Okamura, MD, PhD
study director · Graduate School of Health Sciences, Hiroshima University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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