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PROMOTE: Promotion of the Mind Through Exercise

8. februar 2022 oppdatert av: Teresa Liu-Ambrose, University of British Columbia

Role of Exercise on Cognition and Function in Seniors With Vascular Cognitive Impairment: A Randomized Controlled Trial

The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment.

Studieoversikt

Detaljert beskrivelse

A total of 70 adults diagnosed with Ischaemic Vascular Cognitive Impairment (SIVCI) will be randomized to either a 6 month thrice weekly walking program or usual care. After 6 months of intervention, they will be followed for an additional 6 months. There will be three measurement sessions: baseline, 6 months (end of intervention period); and 12 months.

Studietype

Intervensjonell

Registrering (Faktiske)

71

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

The study will specifically recruit individuals who fulfill the diagnostic criteria for SIVCI as outlined by Erkinjuntti and colleagues (1), which requires the presence of both cognitive syndrome (as defined in Section A below) and small vessel ischaemic disease (as defined in Section B below).

A. Cognitive Syndrome defined as:

  1. Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
  2. Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
  3. Progression: Deterioration of A1 and A2 from a previous higher level of functioning that are not per se interfering with complex occupational and social activities.

B. Small Vessel Ischaemic Disease defined as:

  1. Evidence of relevant cerebrovascular disease by brain imaging (in the last 12 months) defined as the presence of both:

    i. Periventricular and deep white matter lesions: Patchy areas of low attenuation (intermediate density between that of normal white matter and that of intraventricular cerebro-spinal fluid) or diffuse symmetrical areas of low attenuation with ill defined margins extending to the centrum semiovale plus at least one lacunar infarct (correlating to the white matter grading scale greater than 3 from the Cardiovascular Health Study) (2,3); and ii. Absence of cortical and/or cortico-sub-cortical non-lacunar territorial infarcts and watershed infarcts, haemorrhages indicating large vessel disease, signs of normal pressure hydrocephalus, or other specific causes of white matter lesions (e.g., multiple sclerosis, leukodystrophies, sarcoidosis, brain irradiation, etc).

  2. Presence or a history of neurological signs as evidence for cerebrovascular disease such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, dysarthria, gait disorder, extrapyramidal signs consistent with sub-cortical brain lesion(s).

In addition, individuals must meet the following inclusion criteria:

  1. Montreal Cognitive Assessment (MoCA) (4) score less than 26 at screening;
  2. MMSE (5) score of > 20 at screening;
  3. Community-dwelling;
  4. Lives in Metro Vancouver;
  5. Have a caregiver, family member, or friend who interacts with him/her on a weekly basis;
  6. Able to comply with scheduled visits, treatment plan, and other trial procedures;
  7. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
  8. Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;
  9. Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals;
  10. Able to walk independently; and
  11. Must be in sufficient health to participate in study's aerobic-based exercise training program. This will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician indicating individual's appropriateness to participate in an aerobic-based exercise training program.

Exclusion Criteria:

  1. Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI;
  2. Diagnosed with another type of dementia (e.g., AD) or other neurological conditions (e.g., multiple sclerosis, Parkinson's disease, etc.) that affects cognition and mobility;
  3. At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
  4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
  5. Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
  6. Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 2
CON (kontroll; vanlig omsorg)
Nutrition education and usual care as prescribed by neurologist
Eksperimentell: 1
AT (aerobic-based exercise training)
Six months of thrice-weekly walking program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
EXIT-25
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
ADCS-ADL
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Secondary outcomes of interest include: performance of specific executive processes
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Physical function
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Inflammatory biomarkers
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Serum glucose and lipids. These will be assessed at 6 and 12 months.
Tidsramme: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Brain Structure
Tidsramme: Baseline and 6 months
Volume and white matter lesions.
Baseline and 6 months
Brain Function
Tidsramme: Baseline and 6 months
fMRI and resting state
Baseline and 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Penny Brasher, Ph.D, University of British Columbia
  • Hovedetterforsker: Teresa Liu-Ambrose, Ph.D, PT, University of British Columbia
  • Studieleder: Janice Eng, Ph.D, University of British Columbia
  • Studieleder: Lara Boyd, Ph.D, University of British Columbia
  • Studieleder: Robin Hsiung, Ph.D, University of British Columbia
  • Studieleder: Claudia Jacova, Ph.D, University of British Columbia
  • Studieleder: Howard Feldman, MD, University of British Columbia
  • Studieleder: Philip Lee, Ph.D, University of British Columbia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2009

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)

1. mai 2015

Datoer for studieregistrering

Først innsendt

7. desember 2009

Først innsendt som oppfylte QC-kriteriene

8. desember 2009

Først lagt ut (Anslag)

9. desember 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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