Early Phase 1 N=101 Randomized Treatment

Dose Response Study of Aerobic Exercise in Older Adults

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01129115 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Visuospatial Processing — -.02; .19; .08; .29 units on a scale

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Nonexercise control group (Behavioral); Aerobic Exercise Group 1 (Behavioral); Aerobic Exercise Group 2 (Behavioral); Aerobic Exercise Group 3 (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Jeff Burns, MD
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Visuospatial Processing	-.02; .19; .08; .29	—
PRIMARY Change in Maximal Oxygen Consumption	-1; 1.4; 1.7; 2.0	—
PRIMARY Change in Physical Performance Test	.2; .1; -.9; .5	—
SECONDARY Verbal Memory	.52; .61; .47; .32	—
SECONDARY Simple Attention	-.06; .11; .09; .14	—
SECONDARY Set Maintenance & Shifting	.07; -.08; .14; -.13	—
SECONDARY Reasoning	.24; .08; .12; .21	—

Summary

This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.

Eligibility Criteria

Inclusion Criteria

Informed consent
Age 65 years or older
Underactive or sedentary based on the Telephone Assessment of Physical Activity
Community dwelling with a caregiver willing to accompany the participant to visits to the screening evaluation. The caregiver must visit with the subject more than five times a week.
Nondemented: Clinical Dementia Rating (CDR) 0
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
Stable doses of medications for at least 30 days prior to screening.
Likely to participate in all scheduled evaluations and complete the exercise program over 52 weeks

Exclusion Criteria

Dementia
CDR > 0
Current clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to Diagnostic Statistical Manual (DSM)-IV criteria or Geriatric Depression score of 5 or greater.
Significant psychiatric symptoms (e.g., hallucinations) that could impair the completion of the study
Current clinically-significant systemic illness likely to result in deterioration of the patient's condition or affect the patient's safety during the study
History of clinically-evident stroke
Clinically-significant infection within the last 30 days
Myocardial infarction or symptoms of coronary artery disease (e.g., angina) in the last two-years.
Uncontrolled hypertension within the last 6 months
History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
Insulin-dependent diabetes mellitus
Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01129115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.