N/A
N=585
Mindfulness-Based Stress Reduction, Health Education and Exercise
Age-related Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT02665481 ↗Enrolled (actual)
585
Serious AEs
9.1%
Results posted
Sep 2022
Primary outcome: Primary: Memory Composite Score — -0.11; -0.14; -0.13; -0.12 Z-score — p=0.50
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MBSR (Behavioral); Exercise (Behavioral); Health Education (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Memory Composite Score |
-0.11; -0.14; -0.13; -0.12; 0.07; 0.04 | 0.50 |
| PRIMARY Cognitive Control Composite Score |
0.09; -0.01; 0.05; 0.03; 0.26; 0.21 | 0.12 |
| SECONDARY Hippocampal Volume |
3680; 3618; 3641; 3656; 3659; 3600 | 0.53 |
| SECONDARY DLPFC Surface Area |
12295; 12228; 12238; 12285; 12296; 12207 | 0.33 |
| SECONDARY DLPFC Cortical Thickness |
2.77; 2.77; 2.77; 2.77; 2.76; 2.76 | 0.37 |
| SECONDARY OTDL (Observed Tasks of Daily Living). |
20.5; 20.2; 20.3; 20.3; 21.7; 21.2 | 0.57 |
| SECONDARY Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL). |
64.1; 63.0; 64.4; 62.8; 66.8; 66.0 | 0.19 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02665481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.