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Mindful Awareness Program for the Prevention of Dementia: A Randomized Controlled Trial (MAPRCT)

16. srpna 2015 aktualizováno: Rathi Mahendran, National University, Singapore

The objective of this study is to determine whether regular Mindful Awareness Program (MAP) may reverse cognitive impairment and/or prevent further cognitive decline among older adults. 60 elderly with mild cognitive impairment (MCI) were randomized to participate in either the MAP or the Health Education Program (HEP). Sessions will be conducted weekly for 12 weeks, and monthly for 6 months. Participants would be assessed at 3 time-points: at the start, at 3-months and at 9-months.

It was hypothesized that as compared to HEP participants, MAP participants will (1) have improved functional connectivity, (2) have a decreased risk in cognitive decline and (3) report higher psychological well-being.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Participants Study participants are community-dwelling elderly.

Assessments Demographic data will be collected at the start. Psychological tests for depression and anxiety and neuropsychological tests of cognitive functioning will be done at the start, at 3-months and at 9-months, the end of the study. A urine sample will be collected at the start and at the end of the study; blood, fecal and saliva samples will be collected at all three time points. Participants will also undergo a brain neuro-imaging scan at the start of the study and at the 3-months interval.

Intervention Sessions This is an intervention study with a control group design. The strength of this design is its experimental nature with randomization. The control group is the health education program participants.

In the Mindful Awareness Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. The intervention is modelled on similar groups teaching mindfulness meditation to the elderly. The sessions will be led by an experienced instructor who has conducted pilot studies on the use of mindful awareness practice techniques with the elderly.

Participants shall be required to practice these techniques at home daily and will be asked to keep a log of their practice.

For the Health Education Program, all 30 participants will be seen in a group format once a week for 40 minutes for 12 weeks, followed by once a month for 40 minutes for 6 months. Each weekly session will cover a healthy living topic related to maintaining and improving cognitive function. The monthly sessions will review the topics covered with a discussion of how participants have implemented the imparted knowledge to their daily lives. The sessions will be led by an experienced instructor who has conducted similar teaching sessions to the elderly.

Participants will be provided with hand-outs at each session, and there will be discussions to encourage them to practice what is being taught in their daily lives.

Typ studie

Intervenční

Zápis (Aktuální)

55

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Singapur
      • Singapore, Singapur, 648886
        • Training and Research Academy

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. an elderly person between the age of 60 and 85 living in the community and fulfill the operational criteria/definition of MCI:

    1. At least one age-education adjusted neuropsychological test Z score < -1.5
    2. Do not meet DSM-IV criteria for dementia syndrome
    3. Memory / Cognitive complaint, preferably corroborated by a reliable informant
    4. Intact Activities of Daily Living.
  2. function independently
  3. do not suffer from dementia,
  4. able to travel on their own to the data collection site and participate in the MAP or HEP

Exclusion Criteria:

  1. Those who do not meet the above inclusion criteria (ie. Do not have a MCI diagnosis),
  2. Those with Dementia or Normal Ageing
  3. Have a neurological condition (e.g., epilepsy, Parkinson's Disease),
  4. Have a major psychiatric condition (e.g., major depressive disorder)
  5. Suffer from a terminal illness (e.g., cancer).
  6. Have significant visual or hearing impairment, or
  7. Marked upper and lower limb motor difficulties, which may affect their ability to participate in the study.
  8. Are in another interventional study at the same time

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Mindful Awareness Program
18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques
Behaviorální: Mindful Awareness Program
For Mindful Awareness Program, 40-minutes weekly sessions for 12 weeks, followed by 40-minutes monthly for 6 months. The mindful awareness practice techniques to be taught to the elderly include: (1) mindfulness of the senses practice; (2) the body scan practice; (3) walking meditation practice; (4) 'movement nature meant' practice; and (5) visuo-motor limb tasks
Ostatní jména:
  • MAPA
Aktivní komparátor: Health Education Program
18 sessions of health education program focusing on healthy living topics
Behaviorální: Health Education Program

For the Health Education Program, weekly sessions of 40 minutes for 12 weeks, followed by monthly sessions of 40 minutes for 6 months.

Week 1: Diabetes Mellitus Week 2: Hypertension Week 3: Home Safety Week 4: Medications Week 5: Diet Week 6: Depression Week 7: Dementia Week 8: Anxiety Week 9: Sleep Week 10: Exercise Week 11: Coping with bereavement Week 12: Social support

Ostatní jména:
  • HEP

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Mini-Mental State Examination (MMSE) is a brief 30-point questionnaire administered by health care professionals to screen for cognitive impairment. The score ranges from 0 to 30; the higher the score, the less impaired is the participant's cognitive function.
baseline, 3-months, 9-months
Change from baseline Clinical Dementia Rating (CDR ) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care.
baseline, 3-months, 9-months
Change from baseline Rey Auditory Verbal Learning Test (RAVLT) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.
baseline, 3-months, 9-months
Change from baseline Digit Span Task at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory.
baseline, 3-months, 9-months
Change from baseline Colour Trails Tests (CTT) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing.
baseline, 3-months, 9-months
Change from baseline Block Design at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills.
baseline, 3-months, 9-months
Change from baseline Semantic Verbal Fluency (Animals) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Semantic Verbal Fluency (Animals) taps lexical knowledge and semantic memory organization.
baseline, 3-months, 9-months
Change from baseline fMRI scan at 3 months
Časové okno: baseline, 3-months
Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity. Images will be acquired on a 3T Siemens scanner using a standard Siemens whole head coil. All subjects will undergo the task-free fMRI scan after being instructed only to remain awake with their eyes closed. White Matter Diffiusion Tractography Imaging (DTI) will be utilized to identify anatomical connections between functionally correlated regions . The MRI Brain Scan is non-invasive and does not involve the use of Contrast; duration of each scan is approximately one hour.
baseline, 3-months
Change from baseline Biomarkers: blood sample at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months

5 ml of blood will be collected using plasma tubes with indomethacin (15uM final conc) and BHT (20ul of 2mM) will be added prior to freezing (-80 Degree Celsius) to preserve the sample and prevent artifacts (at baseline, 3 months, 9 months).

3 ml of blood will be collected using tubes with no coagulant (at baseline, 3 months and 9 months).

5 ml of blood will be collected using Tempus Blood RNA tubes and will be stored in a refrigerator at approximately 4 Degree Celsius (at baseline and 9 months).

Blood sample would be analysed for cytokine levels; chromosomal studies and terminal telomere restriction fragment length.
baseline, 3-months, 9-months
Change from baseline Biomarkers: urine sample at 9 months
Časové okno: baseline, 9-months
15 ml sample of urine will be collected and frozen as quickly as possible. Urine sample would be analysed for oxidative biomarkers.
baseline, 9-months
Change from baseline Biomarker - fecal sample at 3 months and 9 months
Časové okno: baseline,3 months, 9 months
A fecal sample will also be collected in a tube with RNALater and microbeads. These can be kept at 40C till processing. Fecal sample would be analysed for bacteria.
baseline,3 months, 9 months
Change from baseline Biomarker - saliva sample at 3 months and 9 months
Časové okno: baseline,3 months, 9 months
Saliva will be collected in a test-tube by having participants continuously spit into a 50ml centrifuge tube for 5 minutes. Saliva sample would be analysed for salivary cortisol analysis, DNA extraction and sequencing for stress biomarkers (cytokines).
baseline,3 months, 9 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline Basic Health Screen at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
the Blood pressure, Pulse rate, Height and Weight will be measured.
baseline, 3-months, 9-months
Change from baseline Activities of daily Living (ADL) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Activities of daily Living (ADL) is a questionnaire to screen for functional assessment.
baseline, 3-months, 9-months
Change from baseline Instrumental Activities of Daily Living (IADL) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Instrumental Activities of Daily Living (IADL) is a questionnaire to screen for functional assessment.
baseline, 3-months, 9-months
Change from baseline Geriatric Depression Scale (GDS) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Psychological well-being will be assessed using the Geriatric Depression Scale. Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose.
baseline, 3-months, 9-months
Change from baseline Geriatric Anxiety Inventory (GAI) at 3 months and 9 months
Časové okno: baseline, 3-months, 9-months
Psychological well-being will be assessed using the Geriatric Anxiety Inventory (GAI). Subjects with high scores will not be enrolled into the study and will be informed of the scores and advised to see a doctor at a polyclinic or their family physician with a referral letter prepared for this purpose.
baseline, 3-months, 9-months

Další výstupní opatření

Měření výsledku
Časové okno
Demographic questionnaire
Časové okno: Baseline
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National University, Singapore

Vyšetřovatelé

  • Vrchní vyšetřovatel: Rathi Mahendran, Ph.D, National University, Singapore

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2014

Primární dokončení (Aktuální)

1. června 2015

Dokončení studie (Aktuální)

1. června 2015

Termíny zápisu do studia

První předloženo

3. listopadu 2014

První předloženo, které splnilo kritéria kontroly kvality

5. listopadu 2014

První zveřejněno (Odhad)

10. listopadu 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

18. srpna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. srpna 2015

Naposledy ověřeno

1. srpna 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • B-14-110

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Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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