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

20. marts 2007 opdateret af: Hiroshima University

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

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.

Studieoversigt

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding

120

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
score on a scale of cognitive function immediately after completion of the 6-week intervention and 1 month after completion of the intervention

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Hitoshi Okamura, MD, PhD, Graduate School of Health Sciences, Hiroshima University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

20. marts 2007

Først indsendt, der opfyldte QC-kriterier

20. marts 2007

Først opslået (Skøn)

21. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. marts 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. marts 2007

Sidst verificeret

1. marts 2007

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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