Clinical trial NCT03289546: The Active Mind Study
Official title: Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Cardiovascular Risk Factor
Keywords: mindfulness
exercise
cognitive function
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore whether physical exercise, mindfulness training, or both interventions together can improve cognitive function in individuals with multiple risk factors for the development of dementia in the future.

Detailed description: The investigators will test the feasibility and acceptability of a combined mindfulness training + aerobic training intervention, vs. either alone or none to improve cognitive function in older adults with cognitive impairment. The investigators will also obtain estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary analyses will be conducted to explore the mediating role of changes in aerobic capacity, physical activity, vascular risk factors, and mindfulness skills. Assessments will be conducted at baseline, 3-, and 6- months since baseline.

Eligibility criteria: Inclusion Criteria:

1. Age ≥55
2. Being physically inactive (defined as not meeting current AHA recommendations for physical activity, i.e., \< 150 min of moderate-intensity aerobic activity per week OR \< 75 minutes of vigorous aerobic activity per week
3. Cognitive complaint defined as answering yes to the question "do you feel that your memory or thinking skills have gotten worse recently?"
4. Fluency in English language

Exclusion Criteria:

1. Unwillingness/inability to provide informed consent
2. Contraindications to physical activity as per the participant's PCP assessment
3. Blood pressure \>200/110
4. Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale \[HADS\] depression subscale scores \>14)
5. Acute psychosis (from medical record)
6. Severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \<24)
7. Recent hospitalization (\< 6 weeks)
8. Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)

Primary outcomes:
measure: Retention rates of 80% at the final follow-up visit
timeFrame: 3 months from baseline
measure: Number of participants who attended at least 70% of the planned sessions
timeFrame: 3 months from baseline
measure: Number of participants who completed 70% of the assigned individual home practice exercises
timeFrame: 3 months from baseline
measure: Acceptability will be assessed using a satisfaction survey
timeFrame: 3 months from baseline
Secondary outcomes:
measure: Effect size on cognitive function
timeFrame: baseline, 3, 6 months
measure: An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)
timeFrame: baseline, 3, 6 months
measure: An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, 3, 6 months
measure: Exploratory outcome: waist-to-hip ratio
timeFrame: baseline, 3, 6 months
measure: An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
timeFrame: baseline, 3, 6 months
measure: Exploratory outcome: blood pressure
timeFrame: baseline, 3, 6 months
measure: An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support
timeFrame: baseline, 3, 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital & Warren Alpert Medical School at Brown University
name: Elena Salmoirago-Blotcher, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmoirago-Blotcher E, DeCosta J, Harris K, Breault C, Dunsiger S, Santos C, Snyder P. Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial. Medicine (Baltimore). 2018 May;97(21):e10626. doi: 10.1097/MD.0000000000010626.