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Dose Response Study of Aerobic Exercise in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01129115
First received: May 18, 2010
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Behavioral: Nonexercise control group
Behavioral: Aerobic Exercise Group 1
Behavioral: Aerobic Exercise Group 2
Behavioral: Aerobic Exercise Group 3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nonexercise Control Group 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.
Aerobic Exercise Group 1 Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2 Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3 Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.

Participant Flow:   Overall Study
    Nonexercise Control Group   Aerobic Exercise Group 1   Aerobic Exercise Group 2   Aerobic Exercise Group 3
STARTED   25   25   27   24 
COMPLETED   23   18   21   15 
NOT COMPLETED   2   7   6   9 
Adverse Event                1                2                3                3 
Withdrawal by Subject                1                3                1                4 
Protocol Violation                0                2                2                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were recruited as a convenience sample of volunteers through print and online advertising, community talks, and existing databases of individuals willing to be in research studies Participants had to be at least 65, sedentary or underactive a, and free of cognitive impairment.

Reporting Groups
  Description
Nonexercise Control Group 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.
Aerobic Exercise Group 1 Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
Aerobic Exercise Group 2 Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
Aerobic Exercise Group 3 Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
Total Total of all reporting groups

Baseline Measures
   Nonexercise Control Group   Aerobic Exercise Group 1   Aerobic Exercise Group 2   Aerobic Exercise Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   27   24   101 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.5  (5.8)   73.5  (5.9)   72.5  (5.7)   73.2  (5.3)   72.9  (5.6) 
Gender 
[Units: Participants]
         
Female   16   16   17   16   65 
Male   9   9   10   8   36 


  Outcome Measures
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1.  Primary:   Visuospatial Processing   [ Time Frame: 26 weeks ]

2.  Primary:   Change in Maximal Oxygen Consumption   [ Time Frame: 26 weeks ]

3.  Primary:   Change in Physical Performance Test   [ Time Frame: 26 Week ]

4.  Secondary:   Verbal Memory   [ Time Frame: 26 weeks ]

5.  Secondary:   Simple Attention   [ Time Frame: 26 Weeks ]

6.  Secondary:   Set Maintenance & Shifting   [ Time Frame: 26 Weeks ]

7.  Secondary:   Reasoning   [ Time Frame: 26 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jeffrey Burns
Organization: University of Kansas Medical Center
phone: 913-588-0555
e-mail: kuamp@kumc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeff Burns, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01129115     History of Changes
Other Study ID Numbers: 11883
Study First Received: May 18, 2010
Results First Received: November 4, 2015
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board