NCT00450047

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
Last Updated

March 21, 2007

Status Verified

March 1, 2007

First QC Date

March 20, 2007

Last Update Submit

March 20, 2007

Conditions

Dementia

Keywords

cognitive impairment, ergometer, speed-feedback therapy

Outcome Measures

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

Interventions

Speed-feedback therapy system with a bicycle ergometerDEVICE
Ergometer at conventional settingsDEVICE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Hitoshi Okamura, MD, PhD

    Graduate School of Health Sciences, Hiroshima University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

September 1, 2005

Study Completion

December 1, 2006

Last Updated

March 21, 2007

Record last verified: 2007-03