An interventional study of Mindfulness training and Aerobic training in Cognitive Impairment and Cardiovascular Risk Factor, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
1 mindfulness training class (1 hour) every week for 8 weeks.
Behavioral: Mindfulness training
3 aerobic training sessions (1 hour) per week for 12 weeks.
Behavioral: 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.
Behavioral: Mindfulness training · Behavioral: Aerobic 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'.
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.
Retention rates of 80% at the final follow-up visit
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Number of participants who attended at least 70% of the planned sessions
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Number of participants who completed 70% of the assigned individual home practice exercises
The investigators will consider the study feasible under this condition
Time frame: 3 months from baseline
Acceptability will be assessed using a satisfaction survey
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.
Time frame: 3 months from baseline
Effect size on cognitive function
Preliminary estimates of effect size of mindfulness training alone vs. aerobic training alone, both, or neither on changes from baseline cognitive function.
Time frame: baseline, 3, 6 months
An exploratory outcome: Mindfulness will be assessed using the Five Facets of Mindfulness questionnaire (short form)
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.
Time frame: baseline, 3, 6 months
An exploratory outcome: Depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity
Time frame: baseline, 3, 6 months
Exploratory outcome: waist-to-hip ratio
waist-to-hip ratio
Time frame: baseline, 3, 6 months
An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test
The 6 minute walking test
Time frame: baseline, 3, 6 months
Exploratory outcome: blood pressure
blood pressure
Time frame: baseline, 3, 6 months
An exploratory outcome: Social support will be assessed using the Multidimensional Scale of Perceived Social Support
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).
Time frame: baseline, 3, 6 months
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital