Dose Response Study of Aerobic Exercise in Older Adults

NCT01129115 | Completed Early Phase 1 Results DMC

• 1 other identifier: 11883
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Visuospatial Processing

  Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

  26 weeks

• Change in Maximal Oxygen Consumption

  Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness

  26 weeks

• Change in Physical Performance Test

  The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.

  26 Week

Secondary Outcomes (4)

• Verbal Memory

  26 weeks

• Simple Attention

  26 Weeks

• Set Maintenance & Shifting

  26 Weeks

• Reasoning

  26 Weeks

Study Arms (4)

Nonexercise control group

ACTIVE COMPARATOR

Behavioral: Nonexercise control group

Aerobic Exercise Group 1

EXPERIMENTAL

Behavioral: Aerobic Exercise Group 1

Aerobic Exercise Group 2

EXPERIMENTAL

Behavioral: Aerobic Exercise Group 2

Aerobic Exercise Group 3

EXPERIMENTAL

Behavioral: Aerobic Exercise Group 3

Interventions

Nonexercise control group BEHAVIORAL

Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.

Nonexercise control group

Aerobic Exercise Group 1 BEHAVIORAL

The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.

Aerobic Exercise Group 1

Aerobic Exercise Group 2 BEHAVIORAL

The 100% group will perform 150 minutes a week of exercise over 3 - 5 days

Aerobic Exercise Group 2

Aerobic Exercise Group 3 BEHAVIORAL

The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.

Aerobic Exercise Group 3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeff Burns, MD: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• 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.

  PMID: 29286983 DERIVED

• 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.

  PMID: 26158265 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jeffrey Burns
• Organization: University of Kansas Medical Center

kuamp@kumc.edu

913-588-0555

Study Officials

• Jeffrey Burns, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Director of the Alzheimer & Memory Center & AD Clinical Research Program

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 24, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)