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History of Changes for Study: NCT01129115
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.
Latest version (submitted January 14, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 20, 2010 None (earliest Version on record)
2 May 24, 2010 Study Status and Study Identification
3 August 17, 2010 Study Status and Eligibility
4 February 23, 2011 Study Status
5 June 22, 2012 Sponsor/Collaborators and Study Status
6 February 12, 2013 Recruitment Status, Study Status and Contacts/Locations
7 April 14, 2014 Recruitment Status, Study Status and Study Design
8 January 14, 2016 Outcome Measures, Study Status, Results, Eligibility and Study Description
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Study NCT01129115
Submitted Date:  May 20, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 11883
Brief Title: 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.
Official Title: Dose Response Study of Exercise for Age-related Cognitive Changes
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2010
Overall Status: Recruiting
Study Start: May 2010
Primary Completion: June 2013 [Anticipated]
Study Completion: December 2013 [Anticipated]
First Submitted: May 18, 2010
First Submitted that
Met QC Criteria:
May 20, 2010
First Posted: May 24, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 20, 2010
Last Update Posted: May 24, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Kansas
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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. At 52 weeks, cognition will be reassessed to examine durability of cognitive changes.
Detailed Description:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Nonexercise control group Behavioral: Nonexercise control group
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.
Experimental: Aerobic Exercise Group 1 Behavioral: Aerobic Exercise Group 1
The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Experimental: Aerobic Exercise Group 2 Behavioral: Aerobic Exercise Group 2
The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Experimental: Aerobic Exercise Group 3 Behavioral: Aerobic Exercise Group 3
The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Primary Cognitive Outcome Measure: General Cognition
[ Time Frame: baseline, 26 , and 52 ]

We predict that general cognition will be enhanced by the aerobic exercise intervention. Greater cognitive gains will be made by individuals with more fitness gains. Finally, the intervention will affect all cognitive domains but it will affect executive functioning domains relatively more than other domains.
Secondary Outcome Measures:
1. Secondary Outcomes will measure memory
[ Time Frame: baseline, 26 , and 52 ]

Tests selected consistently yield moderate to large sized exercise-related effects across many studies and possess good ecological validity when aggregated by cognitive domain.
Open or close this module Eligibility
Minimum Age: 65 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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: 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 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
Open or close this module Contacts/Locations
Central Contact Person: Pat Laubinger
Telephone: (913)-588-0685
Email: plaubinger@kumc.edu
Central Contact Backup: KU Alzheimer and Memory Program
Telephone: 913-588-0555
Email: kuamp@kumc.edu
Study Officials: Jeffrey Burns, MD
Principal Investigator
University of Kansas Medical Center
Locations: United States, Kansas
University of Kansas Medical Center
[Recruiting]
Kansas City, Kansas, United States, 66160
Contact:Contact: Jeffrey Burns, MD 913-588-0073 jburns2@kumc.edu
Contact:Principal Investigator: Jeffrey Burns, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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