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Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment

11 luglio 2019 aggiornato da: Chang Gung Memorial Hospital

Evolving Methods to Combine Cognitive and Physical Training for Individuals With Mild Cognitive Impairment: An Efficacy Study

This study aims to investigate and compare the intervention effects of combining exercise and cognitive training (either sequentially or simultaneously in a dual-task paradigm) in elderly with mild cognitive impairment. The investigators hypothesize that (1) both sequential and dual-task training can induce greater improvements in the outcome measures than single mode of training; (2) the improvement in cognitive functions and other outcomes may differ between the groups.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background and study aims:

Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The age-adjusted prevalence of MCI in Taiwan is approximately 18%, while women have higher prevalence for MCI than men. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that cognitive training or exercise has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining exercise and cognitive training remain to be determined. Furthermore, whether exercise and cognitive training should be administered in sequential order or simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects cognitive training, exercise, and combining cognitive and exercise training in individuals with MCI.

Who can participate? Individuals with MCI.

What does the study involve? The participants will receive a total of 36 training sessions, and each session will contain 90 minutes of training. Training frequency will be 2-3 times per week for 12-18 weeks. All participants will received pretreatment test, post treatment test, and a 6-month follow-up test.

What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, physical, and daily functions. There are no risks for participating.

Where to conduct the study? The investigators anticipate recruiting a total of 80 participants from geriatric day care centers and nursing homes from multiple cities in Taiwan.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

55

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • New Taipei City, Taiwan, 249
        • Baliexcelsior Nursing Home
      • Taichung, Taiwan, 412
        • Pine nursing home
      • Taipei, Taiwan, 11150
        • Zhishan community home
      • Taipei, Taiwan, 11165
        • Bailing clinics and nursing homes
      • Taipei, Taiwan, 111
        • Shihlin cum day care center
      • Taipei, Taiwan, 11443
        • Xihu day care center
      • Taipei, Taiwan
        • TaoSheng Nursing home
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital Taoyuan Branch

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. able to follow instruction,
  2. clinical dementia rating (CDR) = 0.5 or 1,
  3. self- or informant-reported memory or cognitive complaint, and
  4. able to perform activities of daily living (Barthel Index ≥ 70).

Exclusion Criteria:

  1. recent myocardial infarction,
  2. heart failure,
  3. recent heart surgery,
  4. severe asthma,
  5. concomitant with other neurological disorders, or
  6. joint deformity that might prevents them performing exercise or cognitive training.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Cognitive training group (Cog)
The BrainHQ program will be used to train different cognitive functions of the participants. The participants will practice tasks that involve the abilities of visuospatial processing, attention, memory, language, and/or executive functions. The tasks will become more difficult as the participants progress in their abilities.
Comportamentale: Cognitive training
visuospatial, attention, memory, and executive abilities
Comparatore attivo: Physical exercise group (PE)
The participants in this group participate in multimodal exercise programs including aerobic exercise, balance, and strength training. The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down. The 70 minutes of exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period.
Comportamentale: Physical exercise
endurance, balance, and mobility
Sperimentale: Sequential training group (Seq)
The participants in this group will first perform 45 minutes of physical exercise followed by 45 minutes of cognitive training. The physical exercise training will be similar to the programs used in the PE group. The entire exercise program for the PE group will contain 5 minutes of warm-up, 35 minutes of physical exercise, and 5 minutes of cool-down. The cognitive training will be implemented with BrainHQ similar to what has been described in the COG group.
Comportamentale: Cognitive training
visuospatial, attention, memory, and executive abilities
Comportamentale: Physical exercise
endurance, balance, and mobility
Sperimentale: Dual-task training group (Dual)
In this group, the participants will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping). The difficulty of the cognitive tasks will increase as the participants improve in their performance.
Comportamentale: Cognitive training
visuospatial, attention, memory, and executive abilities
Comportamentale: Physical exercise
endurance, balance, and mobility

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change scores of Montreal Cognitive Assessment (MoCA)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop test
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Stroop test will be used to assess the processing speed, inhibition, set-shifting, and selective attention abilities. The participants will be tested under 2 conditions: congruent and incongruent conditions. In the congruent condition, the color ink of a word is consistent with the written color name; while the color ink differs from the written color name under the incongruent condition.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go (TUG) test
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The TUG test will be used to assess the mobility and dynamic balance ability. The participants will be required to stand up from a chair, walk 3 meters, turn around, then walk back to the chair, and sit down. The time to complete the TUG test has been shown to be a good indicator to detect potential fallers and frail elderly (Podsiadlo & Richardson, 1991). The test-retest reliability of TUG on individuals with cognitive impairment was excellent (Blankevoort, van Heuvelen, & Scherder, 2013).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change scores of the Verbal Fluency Test
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Verbal fluency tests will be used to evaluate the semantic memory of the participants. The participants will be instructed to say as many words as possible from a given category (i.e., fruit or animal) in 1 minute. The validity, reliability, and normative performance of verbal fluency tests have been well-established (Harrison, Buxton, Husain, & Wise, 2000).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Useful Field of View (UFOV)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Useful field of view (UFOV) is the visual area over which useful information could be obtained at a quick glance without eye or head movements. This UFOV will be assessed with the BrainHQ program. The UFOV will assess the abilities of visuomotor processing speed, divided attention, and selective attention (Ball, Edwards, & Ross, 2007).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the 30 second chair stand test (CST)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The 30 second chair stand test (CST) will be assessed to indicate the strength and endurance level of the lower extremities. The participants will be asked to stand up from a standardized chair and then sit down as many times as possible within 30 seconds. The feasibility and reliability of using CST in people with cognitive impairment have been established to be good (Blankevoort et al., 2013).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Chinese version of the International Physical Activity Questionnaires (IPAQ)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Chinese version of the International Physical Activity Questionnaires (IPAQ) is an international measure for health-related physical activity. A short form of IPAQ will be used to assess changes in physical activity before and after intervention in this study. The reliability and validity of IPAQ has been established across 12 countries (Craig et al., 2003).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Barthel Index (BI)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Assess activities of daily living
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Lawton Instrumental Activities of Daily Living Scale
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Assess activities of daily living.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Disability Assessment for Dementia (DAD)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Assess activities of daily living.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Chinese version of QoLAD will be used.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Caregiver Burden Inventory (CBI)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Chinese version of CBI will be used.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Geriatric Depression Scale (GDS)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Chinese version of short form GDS will be used.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the Community Integration Questionnaire (CIQ)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The CIQ measures items relevant to home integration, social integration, and productive activities.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of the ActiGraph GX3 accelerometers Change scores of the ActiGraph
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The actigraphy will be placed on the waist for a 3-day period immediately before and after the intervention. The participants will wear the actigraphy during all daily activities except for those that involve water (i.e., showering or swimming).
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of evaluating isometric knee flexors and extensors muscle strength
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The participant will be seated upright in a chair with back support, the knee will be placed in 90-degree flexion and the evaluator will stabilize the thing to eliminate synergistic movements. Participants will be asked to perform a maximal isometric contraction of knee flexion and extension with both lower extremities. The investigators will record the mean value of 3 attempts.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of using hand dynamometer to measure grip strength of both hand
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The participant is seated, with the elbow at 90-degree flexion. The investigators will record the mean value of 3 attempts.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The investigators will use the WMS-III subtests, including Faces Recognition (score range 0-48), Verbal Paired Associates (score range 0-32), Word Lists (0-48), and Spatial Span (0-32) to assess the immediate, delayed, and working memory tests. Higher scores indicated better performance for each subtest. The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general memory function.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Lasso di tempo: baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The WAIS-III includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed. The subtests that the investigators will use are the Digit Symbol-Coding (scores range 0-133) and Matrix Reasoning tests (0-26). The raw score of each subtest will also be transferred to standardized Z scores and summed to represent an index of general cognitive function.
baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
BDNF val66met genotype
Lasso di tempo: baseline
Saliva samples will be collected at baseline to determine the Brain-Derived Neurotrophic Factor (BDNF) val66met genotype.
baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chang Gung Memorial Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 gennaio 2015

Completamento primario (Effettivo)

29 gennaio 2018

Completamento dello studio (Effettivo)

13 marzo 2019

Date di iscrizione allo studio

Primo inviato

20 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2015

Primo Inserito (Stima)

31 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 luglio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 103-6651A3

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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