Clinical trial NCT01129115: Dose Response Study of Aerobic Exercise in Older Adults
Official title: Dose Response Study of Exercise for Age-related Cognitive Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 101
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Visuospatial Processing
timeFrame: 26 weeks
measure: Change in Maximal Oxygen Consumption
timeFrame: 26 weeks
measure: Change in Physical Performance Test
timeFrame: 26 Week
Secondary outcomes:
measure: Verbal Memory
timeFrame: 26 weeks
measure: Simple Attention
timeFrame: 26 Weeks
measure: Set Maintenance & Shifting
timeFrame: 26 Weeks
measure: Reasoning
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidoni ED, Perales J, Alshehri M, Giles AM, Siengsukon CF, Burns JM. Aerobic Exercise Sustains Performance of Instrumental Activities of Daily Living in Early-Stage Alzheimer Disease. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):E129-E134. doi: 10.1519/JPT.0000000000000172.
citation: Vidoni ED, Johnson DK, Morris JK, Van Sciver A, Greer CS, Billinger SA, Donnelly JE, Burns JM. Dose-Response of Aerobic Exercise on Cognition: A Community-Based, Pilot Randomized Controlled Trial. PLoS One. 2015 Jul 9;10(7):e0131647. doi: 10.1371/journal.pone.0131647. eCollection 2015.