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

16. august 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

55

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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

60 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindful Awareness Program
18 sessions of mindful awareness program teaching the elderly mindful awareness practice techniques
Adfærdsmæssigt: 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
Andre navne:
  • KORT
Aktiv komparator: Health Education Program
18 sessions of health education program focusing on healthy living topics
Adfærdsmæssigt: 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

Andre navne:
  • HEP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline Mini-Mental State Examination (MMSE) at 3 months and 9 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline Basic Health Screen at 3 months and 9 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tidsramme
Demographic questionnaire
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

National University, Singapore

Efterforskere

  • Ledende efterforsker: Rathi Mahendran, Ph.D, National University, Singapore

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

3. november 2014

Først indsendt, der opfyldte QC-kriterier

5. november 2014

Først opslået (Skøn)

10. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B-14-110

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