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Clinical Trials/NCT03289546
NCT03289546
Completed
Not Applicable

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

The Miriam Hospital1 site in 1 country38 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
The Miriam Hospital
Enrollment
38
Locations
1
Primary Endpoint
Number of participants who completed 70% of the assigned individual home practice exercises
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Salmoirago-Blotcher

Assistant professor of Medicine

The Miriam Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

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.

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)

Study Sites (1)

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