Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Acceptability will be assessed using a satisfaction survey
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Cognitive complaint defined as answering yes to the question "do you feel that your memory or thinking skills have gotten worse recently?"
- •Fluency in English language
Exclusion Criteria
- •Unwillingness/inability to provide informed consent
- •Contraindications to physical activity as per the participant's PCP assessment
- •Blood pressure >200/110
- •Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale [HADS] depression subscale scores >14)
- •Acute psychosis (from medical record)
- •Severe cognitive impairment (Mini-Mental State Examination [MMSE] score <24)
- •Recent hospitalization (< 6 weeks)
- •Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)
Arms & Interventions
Usual care
Mindfulness training only
1 mindfulness training class (1 hour) every week for 8 weeks.
Intervention: Mindfulness training (Behavioral)
Aerobic training only
3 aerobic training sessions (1 hour) per week for 12 weeks.
Intervention: Aerobic training (Behavioral)
mindfulness + aerobic training
2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.
Intervention: Mindfulness training (Behavioral)
mindfulness + aerobic training
2 aerobic training sessions + 1 mindfulness training class every week for 8 weeks, then continue with 3 aerobic training sessions/ week for 4 additional weeks.
Intervention: Aerobic training (Behavioral)
Outcomes
Primary Outcomes
Acceptability will be assessed using a satisfaction survey
Time Frame: 3 months from baseline
Acceptability will be assessed using a satisfaction survey. The intervention will be considered acceptable if ≥80% of participants responds that they are at least somewhat satisfied with the intervention.
Number of participants who completed 70% of the assigned individual home practice exercises
Time Frame: 3 months from baseline
The investigators will consider the study feasible under this condition
Number of participants who attended at least 70% of the planned sessions
Time Frame: 3 months from baseline
The investigators will consider the study feasible under this condition
Retention rates of 80% at the final follow-up visit
Time Frame: 3 months from baseline
The investigators will consider the study feasible under this condition
Secondary Outcomes
- Exploratory outcome: waist-to-hip ratio(baseline, 3, 6 months)
- An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test(baseline, 3, 6 months)
- Exploratory outcome: blood pressure(baseline, 3, 6 months)
- An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support(baseline, 3, 6 months)
- An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)(baseline, 3, 6 months)
- Effect size on cognitive function(baseline, 3, 6 months)
- An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)(baseline, 3, 6 months)
Investigators
Elena Salmoirago-Blotcher
Assistant professor of Medicine
The Miriam Hospital