Cardiovascular Risk Factor, Cognitive Impairment
Conditions
Keywords
mindfulness, exercise, cognitive function
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.
Interventions
BEHAVIORALMindfulness training
The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations (body scan); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'.
BEHAVIORALAerobic training
Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rates of 80% at the final follow-up visit | 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 | 3 months from baseline | The investigators will consider the study feasible under this condition |
| Number of participants who completed 70% of the assigned individual home practice exercises | 3 months from baseline | The investigators will consider the study feasible under this condition |
| Acceptability will be assessed using a satisfaction survey | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test | baseline, 3, 6 months | The 6 minute walking test |
| Effect size on cognitive function | baseline, 3, 6 months | Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function. |
| An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support | baseline, 3, 6 months | A 12-item, uni-dimensional tool to measure how one perceives their social support system, including individuals sources of social support (i.e., family, friends, and significant other). |
| Exploratory outcome: blood pressure | baseline, 3, 6 months | blood pressure |
| An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form) | baseline, 3, 6 months | Five Facets of Mindfulness questionnaire (short form) is a 12-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. |
| An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) | baseline, 3, 6 months | The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity |
| Exploratory outcome: waist-to-hip ratio | baseline, 3, 6 months | waist-to-hip ratio |
Countries
United States
Outcome results
None listed