Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study

Completed · Not applicable

Conditions studied: Mild Cognitive Impairment, Cognitive Disorders

In brief

This is a small pilot trial of a 5 month aerobic exercise intervention in participants with MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to exercise without an assigned buddy. The investigators hypothesize that participants with MCI who exercise with a buddy will have higher adherence to the protocol and greater improvement in 400 meter walk time.

Key facts

Study ID

NCT01561820

Run by

Wake Forest University

People needed

15

Starts

2011-11-01

Expected to finish

2012-12-01

Last updated by the study team

2019-09-26

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants:
• Age 60 and up
• Montreal Cognitive Assessment (MoCA) score 16-28
• CDR= 0.5 with memory box at least 0.5.
• Have a person (study partner) who can answer questions about their cognition for the CDR, FAQ and NPI-Q. This should be the same person who will come to all clinic visits whenever possible. This person can be called to answer these questions if unable to come into the clinic.
• Sedentary for past 3 months (< 45 min /wk of exercise, including walking)
• Able to walk 400 meters in < 15 min without assistance
• Willing to exercise 4 days a week at Body Check at CompRehab
• Physician approval for participation in the exercise intervention
• Buddy:
• No report of memory problem
• MoCA score > 24 if > HS education; > 23 if 9-12 years; > 22 if ,< 9 years of education

You may not qualify if…

• Due to Cognitive Confounders:
• Uncontrolled depression (PHQ-9 > 10)
• Schizophrenia or bipolar disorder
• Parkinson's disease
• Hachinski ischemic index > 4
• Daily use of highly anticholinergic medications (such as amitriptyline, diphenhydramine, scopolamine, etc) or benzodiazepines
• Use of stable dose of Cholinesterase inhibitors will be permitted. Must be on a stable dose for 4 weeks.
• Non-English speaking (as we are unable to administer the cognitive tests in languages other than English for this pilot)
• Vitamin B12 deficiency
• Uncontrolled hypothyroidism as measured by TSH blood test
• Due to increased risk of or low likelihood of compliance with the exercise program:
• Active ischemic heart disease or angina
• symptomatic heart failure
• stroke
• screening blood pressure SBP > 170 or < 90; DBP > 100 or < 45
• Parkinson's disease or other neurologic disorder that might make exercise on a treadmill or bike unsafe
• Current or planned treatment for cancer
• peripheral artery disease that limits exercise capacity
• Severe respiratory-disease (e.g., COPD) that limits exercise capacity
• Severe arthritis that limits exercise capacity
• Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (> 3 mm) on ECG
• Severe anemia (Hgb < 8)
• Diagnosis of Diabetes and on medication
• Drinks more than 14 alcoholic drinks per week
• Dependent on a cane, walker or other device that would inhibit then from using a treadmill

Where it is running

• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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