The Active Mind Study

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Cognitive Impairment
• Interventions: Behavioral: Mindfulness training; Behavioral: Aerobic training

• Registration Number: NCT03289546
• Lead Sponsor: The Miriam Hospital

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 Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-21
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
mindfulness + aerobic training	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.
Mindfulness training only	Mindfulness training	1 mindfulness training class (1 hour) every week for 8 weeks.
Aerobic training only	Aerobic training	3 aerobic training sessions (1 hour) per week for 12 weeks.
mindfulness + aerobic training	Mindfulness 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.

Primary Outcome Measures

Name	Time	Method
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
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
Retention rates of 80% at the final follow-up visit	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 Outcome Measures

Name	Time	Method
Exploratory outcome: waist-to-hip ratio	baseline, 3, 6 months	waist-to-hip ratio
An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test	baseline, 3, 6 months	The 6 minute walking test
Exploratory outcome: blood pressure	baseline, 3, 6 months	blood pressure
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).
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.
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: 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

Trial Locations

Locations (1)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States