Trials / Completed
CompletedNCT02665481
Mindfulness-Based Stress Reduction, Health Education and Exercise
Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 585 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 65 Years – 84 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | MBSR | |
| BEHAVIORAL | Exercise | |
| BEHAVIORAL | Health Education |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2020-06-01
- Completion
- 2021-05-01
- First posted
- 2016-01-27
- Last updated
- 2022-09-28
- Results posted
- 2022-09-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02665481. Inclusion in this directory is not an endorsement.