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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01128361
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Behavioral: Aerobic Exercise
Behavioral: Stretching
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 39 37
Completed 34 34
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             5             2
Arm/Group Title Aerobic Exercise Stretching Total
Hide Arm/Group Description 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: 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 of all reporting groups
Overall Number of Baseline Participants 39 37 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 37 participants 76 participants
74.4  (6.7) 71.4  (8.4) 72.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
Female
18
  46.2%
21
  56.8%
39
  51.3%
Male
21
  53.8%
16
  43.2%
37
  48.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 37 participants 76 participants
39 37 76
Clinical Dementia Rating Sum of Boxes   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 39 participants 37 participants 76 participants
3.54  (1.99) 3.55  (1.60) 3.54  (1.81)
[1]
Measure Description: 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).
1.Primary Outcome
Title Memory Composite
Hide Description

A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged.

Numbers closer to positive indicate better memory performance. The 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.

Time Frame week 0, 13, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Linear mixed models with all available data were used. Thus the overall number of participants analyzed does not necessarily match the means reported at each timepoint.
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: units on a standardized scale
Baseline Number Analyzed 39 participants 37 participants
-2.5  (1.4) -2.8  (1.4)
Week 13 Number Analyzed 36 participants 37 participants
-2.3  (1.5) -2.8  (1.5)
Week 26 Number Analyzed 34 participants 34 participants
-2.3  (1.7) -2.7  (1.7)
2.Primary Outcome
Title Executive Function Composite
Hide Description

A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged.

Numbers closer to positive indicate better executive function performance. . The 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.

Time Frame Week 0, 13, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Linear mixed models were used with all available data included. Overall numbers analyzed do not necessarily match the outcome measure at each timepoint
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: standardized units on a scale
Baseline Number Analyzed 39 participants 37 participants
-1.12  (.82) -1.34  (.85)
Week 13 Number Analyzed 36 participants 37 participants
-1.09  (.86) -1.25  (.94)
Week 26 Number Analyzed 34 participants 34 participants
-1.2  (.9) -1.33  (.97)
3.Primary Outcome
Title Disability Assessment for Dementia
Hide Description This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.
Time Frame Week 0, 13, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Linear mixed models were used with all available data. Overall number of participants may not match numbers at each timepoint.
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: percentage on a scale
Baseline Number Analyzed 39 participants 37 participants
88  (12.3) 91.2  (8)
Week 13 Number Analyzed 36 participants 37 participants
89.8  (12.5) 89.5  (12.8)
Week 26 Number Analyzed 34 participants 34 participants
89.5  (13.7) 86.7  (13.3)
4.Primary Outcome
Title Cornell Scale for Depression in Dementia
Hide Description The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.
Time Frame Week 0, 13, and 26
Hide Outcome Measure Data
Hide Analysis Population Description
Linear mixed models were used with all available data. Overall numbers analyzed may not reflect numbers at each timepoint
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 39 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 39 participants 37 participants
7.4  (3.8) 8.6  (5.1)
Week 13 Number Analyzed 36 participants 37 participants
8.1  (4.4) 8.4  (4.6)
Week 26 Number Analyzed 34 participants 34 participants
7.8  (4.4) 7.8  (5.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aerobic Exercise Stretching
Hide Arm/Group Description 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: 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.
All-Cause Mortality
Aerobic Exercise Stretching
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Aerobic Exercise Stretching
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/37 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aerobic Exercise Stretching
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/39 (33.33%)      9/37 (24.32%)    
Cardiac disorders     
Cardiac [1]  8/39 (20.51%)  8 4/37 (10.81%)  4
Musculoskeletal and connective tissue disorders     
Muscle soreness or joint pain  5/39 (12.82%)  5 5/37 (13.51%)  5
Fall  0/39 (0.00%)  0 1/37 (2.70%)  1
Skin and subcutaneous tissue disorders     
Skin breakdown  2/39 (5.13%)  2 0/37 (0.00%)  0
[1]
Arrhythmia or EKG abnormality noted on exercise testing
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jeffrey Burns
Organization: University of Kansas Medical Center
Phone: 913-588-0555
EMail: jburns2@kumc.edu
Layout table for additonal information
Responsible Party: Jeff Burns, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01128361    
Other Study ID Numbers: 11969
First Submitted: May 18, 2010
First Posted: May 21, 2010
Results First Submitted: January 22, 2017
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017