The Active Mind Study

Cognitive Impairment Clinical Trial

Official title:

Exploring Synergistic Effects Of Aerobic Exercise And Mindfulness Training On Cognitive Function In Older Adults: A Pilot, Proof Of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289546
• Other study ID #: 201602917
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Behavioral:
• Mindfulness 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'.
• Aerobic 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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rates of 80% at the final follow-up visit	The investigators will consider the study feasible under this condition	3 months from baseline
Primary	Number of participants who attended at least 70% of the planned sessions	The investigators will consider the study feasible under this condition	3 months from baseline
Primary	Number of participants who completed 70% of the assigned individual home practice exercises	The investigators will consider the study feasible under this condition	3 months from baseline
Primary	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.	3 months from baseline
Secondary	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.	baseline, 3, 6 months
Secondary	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.	baseline, 3, 6 months
Secondary	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	baseline, 3, 6 months
Secondary	Exploratory outcome: waist-to-hip ratio	waist-to-hip ratio	baseline, 3, 6 months
Secondary	An exploratory outcome: Exercise capacity will be assessed via the 6 minute walking test	The 6 minute walking test	baseline, 3, 6 months
Secondary	Exploratory outcome: blood pressure	blood pressure	baseline, 3, 6 months
Secondary	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).	baseline, 3, 6 months