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Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01128361
First received: May 18, 2010
Last updated: January 22, 2017
Last verified: January 2017
Results First Received: January 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Behavioral: Aerobic Exercise
Behavioral: Stretching

  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
Aerobic Exercise Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
Stretching Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.

Participant Flow:   Overall Study
    Aerobic Exercise   Stretching
STARTED   39   37 
COMPLETED   34   34 
NOT COMPLETED   5   3 
Lost to Follow-up                0                1 
Withdrawal by Subject                5                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.
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Reporting Groups
  Description
Aerobic Exercise Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
Stretching Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
Total Total of all reporting groups

Baseline Measures
   Aerobic Exercise   Stretching   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   37   76 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      39 100.0%      37 100.0%      76 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.4  (6.7)   71.4  (8.4)   72.9  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  46.2%      21  56.8%      39  51.3% 
Male      21  53.8%      16  43.2%      37  48.7% 
Region of Enrollment 
[Units: Participants]
     
United States   39   37   76 
Clinical Dementia Rating Sum of Boxes [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.54  (1.99)   3.55  (1.60)   3.54  (1.81) 
[1] The Clinical Dementia Rating (CDR) is a scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. The sum of each domain (CDR Sum of Boxes) is used as a measure of dementia severity from 0 (no impairment) to 18 (severe impairment).


  Outcome Measures
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1.  Primary:   Memory Composite   [ Time Frame: week 0, 13, and 26 ]

2.  Primary:   Executive Function Composite   [ Time Frame: Week 0, 13, and 26 ]

3.  Primary:   Disability Assessment for Dementia   [ Time Frame: Week 0, 13, and 26 ]

4.  Primary:   Cornell Scale for Depression in Dementia   [ Time Frame: Week 0, 13, and 26 ]


  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: jburns2@kumc.edu


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

Responsible Party: Jeff Burns, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01128361     History of Changes
Other Study ID Numbers: 11969
Study First Received: May 18, 2010
Results First Received: January 22, 2017
Last Updated: January 22, 2017