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Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)

12 september 2022 uppdaterad av: Washington University School of Medicine

Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise

The purpose of this research is to examine the effects of four interventions on age-related cognitive decline in healthy older adults. The investigators will examine the effects of Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based aerobic exercise, and their combination, compared to a discussion group.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

MBSR teaches mindfulness, or the focusing of attention and awareness, through various meditation techniques. Mindfulness meditation practices appear to produce neurocircuitry changes that are the reverse of those seen in age-related cognitive decline. It is widely available, acceptable to older people, and carries minimal risk of side effects or adverse events. Exercise - specifically, intense, multi-component exercise - also appears to affect brain structure and function and improve cognitive performance.

The investigators will randomize 580 non-demented healthy adults aged 65 to 84 to one of four conditions: MBSR alone, exercise alone, MBSR + exercise, or a health education discussion group control condition.

The study will consist of a 6-month acute intervention phase with weekly visits followed by a 12-month maintenance phase with weekly or monthly visits and other prompts to maintain intervention behaviors.

Assessments include cognitive tests, biomarkers, neuroimaging assessments, functional assessments to examine real-world benefits of the interventions, and other behavioral assessments to characterize participants and pave the way for further exploratory analyses.

Studietyp

Interventionell

Inskrivning (Faktisk)

585

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Diego, California, Förenta staterna, 92122
        • University of California San Diego
    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år till 84 år (Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Community-living men and women age 65 to 84.
  • Self-reported cognitive complaints that are a normal part of aging.
  • No current meditation practice nor prior training in it.
  • Sedentary.

Exclusion Criteria:

  • Known diagnosis of dementia, mild cognitive impairment, other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease), psychotic disorder, or any unstable psychiatric condition.
  • Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or would interfere with the assessments, such as taking medications for diabetes or ferromagnetic metal/bridgework that would interfere with MRI signal.
  • IQ <70 as estimated by the Wechsler Test of Adult Reading
  • Sensory impairment (language, hearing, or visual) that would prevent participation.
  • Alcohol abuse within 6 months.
  • Current illicit drug use.
  • Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.
  • Medications that interfere with measurements, including cancer chemotherapy, glucocorticoids, and interferon.
  • Inability to cooperate with protocol.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Faktoriell uppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MBSR
Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life.
Beteende: MBSR
Andra namn:
  • Mindfulness-baserad stressreduktion
Experimentell: Exercise
The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months.
Beteende: Träning
Andra namn:
  • Flerkomponents intensitetsbaserad träning
Experimentell: MBSR + Exercise

This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study.

Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT).
Beteende: MBSR
Andra namn:
  • Mindfulness-baserad stressreduktion
Beteende: Träning
Andra namn:
  • Flerkomponents intensitetsbaserad träning
Aktiv komparator: Health Education
Health Education is a group-based intervention that increases health-related knowledge and action. Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months.
Beteende: Hälsoutbildning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Memory Composite Score
Tidsram: Month 0, Month 3, Month 6, and Month 18
The memory composite variable consists of the list recall, paragraph recall, and picture sequence memory tasks. For each memory variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite memory variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean.
Month 0, Month 3, Month 6, and Month 18
Cognitive Control Composite Score
Tidsram: Month 0, Month 3, Month 6, Month 18
The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks. For each cognitive variable, a z score is computed for each participant [(participant score - mean)/standard deviation]. Then the composite cognitive control variable is created by averaging the z scores. The higher the z-score, the better the outcome. A Z-score of 0 represents the population mean.
Month 0, Month 3, Month 6, Month 18

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hippocampal Volume
Tidsram: Month 0, Month 6, Month 18
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
Month 0, Month 6, Month 18
DLPFC Surface Area
Tidsram: Month 0, Month 6, Month 18
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
Month 0, Month 6, Month 18
DLPFC Cortical Thickness
Tidsram: Month 0, Month 6, and Month 18
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
Month 0, Month 6, and Month 18
OTDL (Observed Tasks of Daily Living).
Tidsram: Month 0, Month 6, Month 18
The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving. Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook). The scores were summed with the total score having a range from 0 to 28. The higher the score, the more likely the participant is able to complete everyday activities.
Month 0, Month 6, Month 18
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
Tidsram: Month 0, Month 3, Month 6, Month 18
The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults. The total score ranges from 18 to 90 where a higher score represents a better outcome.
Month 0, Month 3, Month 6, Month 18

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington University School of Medicine

Samarbetspartners

University of California, San Diego
National Institutes of Health (NIH)
National Institute on Aging (NIA)
National Center for Complementary and Integrative Health (NCCIH)
The Brain Research Foundation

Utredare

  • Huvudutredare: Eric J Lenze, MD, Washington University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2015

Primärt slutförande (Faktisk)

1 juni 2020

Avslutad studie (Faktisk)

1 maj 2021

Studieregistreringsdatum

Först inskickad

12 januari 2016

Först inskickad som uppfyllde QC-kriterierna

22 januari 2016

Första postat (Uppskatta)

27 januari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 september 2022

Senast verifierad

1 september 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 201410093
  • 1R01AG049369-01 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available for release upon request to qualified investigators.

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