- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01983930
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this pilot study intervention is to investigate brain mechanisms of response to memory enhancement training (MET) compared to Kundalini yoga and "Kirtan Kriya" meditation using functional magnetic resonance imaging (fMRI) that will be acquired from each subject at baseline and at 12 weeks (post-randomization).
Overall, the investigators anticipate recruiting 66 adults with memory complaints and diagnosed with MCI for adults 55 years old and older. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. All assessments will be completed immediately after the interventions for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor the overall benefit of the intervention.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
California
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Los Angeles, California, Forenede Stater, 90095
- UCLA Semel Institute
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Mild cognitive impairment amnestic type
- Clinical Dementia Rating scale score of 0.5
- SufficientEnglish proficiency and 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV
- Capacity to provide informed consent.
Exclusion criteria:
- Any current or past psychiatric disorders, or recent unstable medical or neurological disorders
- Any disabilities preventing their participation in the memory enhancement training (MET) (e.g. severe visual or hearing impairment)
- Insufficient English proficiency
- Diagnosis of dementia
- Mini Mental Health Examination score of 24 and below
- Psychoactive medications
- Participation in a psychotherapy that involves cognitive training
- Do not meet criteria for Mild cognitive impairment subtype
- Prior or current training in yoga.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Hukommelsestræning
Gruppehukommelsestræning vil blive administreret for amnestisk mild kognitiv svækkelse (MCI)
|
Deltagerne vil deltage i en ugentlig hukommelsestræningstime i 12 uger samt modtage daglige hukommelseslektier (12 minutters varighed) i de 12 uger.
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|
Eksperimentel: Kundalini yoga and meditation
Participants will engage in weekly yoga classes and daily 20 minute meditation
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Deltagerne vil deltage i en 60 minutters yoga- og meditationssession ugentligt i 12 uger og vil blive tildelt en daglig Kirtan Kriya-meditation (12 minutters varighed) i 12 uger.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
Tidsramme: At baseline and at 6 months
|
Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning.
Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores.
The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials.
When scoring the HVLT, the three learning trials are combined to calculate a total recall score.
Total scores range from 0-36 with higher scores indicating better outcome.
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At baseline and at 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Global Impression Scale
Tidsramme: Baseline, weeks 2, 4, 6, 8, 10, 12, 24
|
The CGI measures severity of illness and global improvement.
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).
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Baseline, weeks 2, 4, 6, 8, 10, 12, 24
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Geriatric Depression Scale (GDS)
Tidsramme: Baseline and Week 24
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Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials.
The GDS is a 30-item screening tool used to identify depression in older adults.
In scoring the Geriatric Depression Scale, each item is scored 0 or 1.
The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.
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Baseline and Week 24
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Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity
Tidsramme: Baseline and week 12
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FMRI scans will be obtained at baseline and after 12 weeks follow up.
Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.
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Baseline and week 12
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Helen Lavretsky, MD, MS, UCLA Semel Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Kognitiv dysfunktion
- Hukommelsesforstyrrelser
- Terapeutik
- Mind-body terapier
- Komplementære terapier
- Åndelige terapier
- Patientpleje
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Adfærdsterapi
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Neurologisk rehabilitering
- Afslapningsterapi
- Kognitiv træning
- Meditation
Andre undersøgelses-id-numre
- 13-000821
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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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