Dose Response Study of Aerobic Exercise in Older Adults

Jeff Burns, MD

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer's Disease

Treatments: Behavioral: Aerobic Exercise Group 1; Behavioral: Aerobic Exercise Group 2; Behavioral: Aerobic Exercise Group 3; Behavioral: Nonexercise control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01129115

11883

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

Nonexercise control group

Active Comparator group

Treatment:

Behavioral: Nonexercise control group

Aerobic Exercise Group 1

Experimental group

Treatment:

Behavioral: Aerobic Exercise Group 1

Aerobic Exercise Group 2

Experimental group

Treatment:

Behavioral: Aerobic Exercise Group 2

Aerobic Exercise Group 3

Experimental group

Treatment:

Behavioral: Aerobic Exercise Group 3