Trial Outcomes & Findings for aeRobic Exercise and Cognitive Health (NCT NCT02384993)
NCT ID: NCT02384993
Last Updated: 2024-03-18
Results Overview
This intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
up to 26 weeks
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
Usual Physical Activity
Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise \& Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
|
Enhanced Physical Activity
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Usual Physical Activity
Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise \& Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
|
Enhanced Physical Activity
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
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|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
aeRobic Exercise and Cognitive Health
Baseline characteristics by cohort
| Measure |
Usual Physical Activity
n=12 Participants
Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise \& Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
|
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 50-59 years
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Age, Customized
Age · 60-69 years
|
7 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Age, Customized
Age · 70-79 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Years of Education
|
16.67 years
STANDARD_DEVIATION 2.57 • n=39 Participants
|
16.58 years
STANDARD_DEVIATION 2.47 • n=41 Participants
|
16.62 years
STANDARD_DEVIATION 2.46 • n=35 Participants
|
|
Number of Participants with APOE e4 positive
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
BMI
|
29.38 kg/m^2
STANDARD_DEVIATION 5.96 • n=39 Participants
|
29.37 kg/m^2
STANDARD_DEVIATION 4.93 • n=41 Participants
|
29.37 kg/m^2
STANDARD_DEVIATION 5.35 • n=35 Participants
|
|
Systolic blood pressure
|
128.50 mmHg
STANDARD_DEVIATION 19.65 • n=39 Participants
|
121.88 mmHg
STANDARD_DEVIATION 18.39 • n=41 Participants
|
125.19 mmHg
STANDARD_DEVIATION 18.92 • n=35 Participants
|
|
Diastolic blood pressure
|
79.92 mmHg
STANDARD_DEVIATION 9.47 • n=39 Participants
|
75.33 mmHg
STANDARD_DEVIATION 10.20 • n=41 Participants
|
77.63 mmHg
STANDARD_DEVIATION 9.90 • n=35 Participants
|
|
Number of Participants with Parental History of Alzheimer's Disease
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
MMSE
|
29.67 scores on a scale
STANDARD_DEVIATION 0.49 • n=39 Participants
|
29.58 scores on a scale
STANDARD_DEVIATION 0.67 • n=41 Participants
|
29.62 scores on a scale
STANDARD_DEVIATION 0.58 • n=35 Participants
|
PRIMARY outcome
Timeframe: up to 26 weeksThis intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.
Outcome measures
| Measure |
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
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Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group
|
99.2 Percentage of Sessions
Standard Deviation 2.7
|
—
|
PRIMARY outcome
Timeframe: up to 3 yearsFeasibility is in part defined as at least 90% of enrolled participants completed the study.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Feasibility: Percentage of Participants Who Completed the Study
|
12 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning. This method measures the brain's use of blood sugar while in a resting state. Measurements were taken in the posterior cingulate cortex (PCC). An increase in this measure indicates an increase in the brain's uptake and usage of blood sugar.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
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|---|---|---|
|
Cerebral Glucose Metabolism as Measured by FDG PET Scanning
baseline
|
1.49 arbitrary units
Standard Deviation 0.04
|
1.50 arbitrary units
Standard Deviation 0.03
|
|
Cerebral Glucose Metabolism as Measured by FDG PET Scanning
26 weeks
|
1.52 arbitrary units
Standard Deviation 0.04
|
1.54 arbitrary units
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.
Outcome measures
| Measure |
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=9 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
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|---|---|---|
|
Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity
Baseline
|
45.05 cm/second
Interval 42.59 to 47.51
|
41.13 cm/second
Interval 33.97 to 48.29
|
|
Ultrasound-Measured Cerebral Blood Flow - Mean Flow Velocity
26 Weeks
|
49.47 cm/second
Interval 42.16 to 56.78
|
45.85 cm/second
Interval 37.35 to 54.36
|
SECONDARY outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
California Verbal Learning Test-II Total Score
baseline
|
49.58 words
Standard Deviation 11.06
|
53.18 words
Standard Deviation 7.99
|
|
California Verbal Learning Test-II Total Score
26 weeks
|
53.33 words
Standard Deviation 9.18
|
60.64 words
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: up to 26 weeks (measured at baseline and 26 weeks)The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score
baseline
|
60.00 seconds
Standard Deviation 11.71
|
64.82 seconds
Standard Deviation 15.11
|
|
Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score
26 weeks
|
60.00 seconds
Standard Deviation 11.99
|
57.64 seconds
Standard Deviation 11.96
|
SECONDARY outcome
Timeframe: up to 26 weeks (assessed at baseline and 26 weeks)The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Mini Mental State Examination (MMSE) Score
baseline
|
29.67 scores on a scale
Standard Deviation 0.49
|
29.55 scores on a scale
Standard Deviation 0.69
|
|
Mini Mental State Examination (MMSE) Score
26 weeks
|
29.08 scores on a scale
Standard Deviation 1.24
|
29.55 scores on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
California Verbal Learning Test-II Long Delay Score
baseline
|
10.83 words
Standard Deviation 2.83
|
12.00 words
Standard Deviation 2.72
|
|
California Verbal Learning Test-II Long Delay Score
26 weeks
|
11.42 words
Standard Deviation 3.26
|
14.00 words
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: up to 26 weeks (assessed at baseline and 26 weeks)The Profile of Mood States was used to assess mood. POMS is divided into six subscales including tension-anxiety (9 items, score range: 0-36), depression (15 items, range: 0-60), anger-hostility (12 items, range: 0-48), vigor-activity (8 items, range: 0-32), fatigue (7 items, range: 0-28), and confusion-bewilderment (7 items, range: 0-28). Total mood disturbance is calculated by adding five of the six subscales (Tension, Depression, Anger, Fatigue, and Confusion) and subtracting Vigor (Scores range from -32 to 200). Lower scores typically indicate more steady mood profiles. Higher scores indicate more mood disturbance.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Profile of Mood States (POMS) Score
Post-intervention Vigor
|
16.25 score on a scale
Standard Deviation 6.86
|
15.36 score on a scale
Standard Deviation 4.74
|
|
Profile of Mood States (POMS) Score
Baseline Fatigue
|
4.92 score on a scale
Standard Deviation 3.55
|
6.58 score on a scale
Standard Deviation 5.25
|
|
Profile of Mood States (POMS) Score
Post-intervention Fatigue
|
7.64 score on a scale
Standard Deviation 4.15
|
5.91 score on a scale
Standard Deviation 4.70
|
|
Profile of Mood States (POMS) Score
Baseline Confusion
|
5.17 score on a scale
Standard Deviation 2.95
|
6.83 score on a scale
Standard Deviation 2.52
|
|
Profile of Mood States (POMS) Score
Post-intervention Confusion
|
5.55 score on a scale
Standard Deviation 3.05
|
5.45 score on a scale
Standard Deviation 3.17
|
|
Profile of Mood States (POMS) Score
Baseline Total Mood Disturbance
|
9.58 score on a scale
Standard Deviation 19.71
|
15.17 score on a scale
Standard Deviation 19.94
|
|
Profile of Mood States (POMS) Score
Baseline Tension
|
8.00 score on a scale
Standard Deviation 2.92
|
7.67 score on a scale
Standard Deviation 3.11
|
|
Profile of Mood States (POMS) Score
Post-intervention Tension
|
8.64 score on a scale
Standard Deviation 3.41
|
6.00 score on a scale
Standard Deviation 3.82
|
|
Profile of Mood States (POMS) Score
Baseline Depression
|
5.17 score on a scale
Standard Deviation 6.60
|
4.83 score on a scale
Standard Deviation 6.64
|
|
Profile of Mood States (POMS) Score
Post-intervention Depression
|
5.36 score on a scale
Standard Deviation 5.52
|
3.27 score on a scale
Standard Deviation 5.53
|
|
Profile of Mood States (POMS) Score
Baseline Anger
|
3.17 score on a scale
Standard Deviation 4.49
|
5.50 score on a scale
Standard Deviation 4.98
|
|
Profile of Mood States (POMS) Score
Post-intervention Anger
|
4.27 score on a scale
Standard Deviation 3.41
|
3.82 score on a scale
Standard Deviation 5.10
|
|
Profile of Mood States (POMS) Score
Baseline Vigor
|
16.83 score on a scale
Standard Deviation 6.31
|
16.25 score on a scale
Standard Deviation 6.86
|
|
Profile of Mood States (POMS) Score
Post-intervention Total Mood Disturbance
|
16.09 score on a scale
Standard Deviation 15.64
|
7.55 score on a scale
Standard Deviation 20.47
|
SECONDARY outcome
Timeframe: up to 26 weeks (assessed at baseline and 26 weeks)Hippocampal volume will be assessed using T1-weighted 3T MRI images.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Change in Hippocampal Volume
|
-23.67 mm cubed
Standard Deviation 222.50
|
-33.64 mm cubed
Standard Deviation 177.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)
baseline
|
25.74 mL/kg/min
Standard Error 6.58
|
23.57 mL/kg/min
Standard Error 4.97
|
|
Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)
26 weeks
|
27.18 mL/kg/min
Standard Error 6.05
|
27.46 mL/kg/min
Standard Error 4.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visitLevels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: over 26 weeks (assessed at baseline visit and at week-26 visit)Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=9 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Endothelial Function
Baseline
|
2.22 Percentage of dilation
Standard Deviation 1.78
|
1.86 Percentage of dilation
Standard Deviation 0.93
|
|
Endothelial Function
26 Weeks
|
2.71 Percentage of dilation
Standard Deviation 1.69
|
2.33 Percentage of dilation
Standard Deviation 1.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 26 weeks (measured at baseline and 26 weeks)Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Sedentary Behavior Measured Via Accelerometer
Baseline
|
670.73 minute/day
Standard Deviation 27.2
|
726.0 minute/day
Standard Deviation 22.9
|
|
Sedentary Behavior Measured Via Accelerometer
26 weeks
|
690.1 minute/day
Standard Deviation 26.7
|
698.6 minute/day
Standard Deviation 27.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 26 weeks (assessed at baseline and 26 weeks)Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.
Outcome measures
| Measure |
Enhanced Physical Activity
n=12 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Enhanced Physical Activity
n=11 Participants
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
|---|---|---|
|
Moderate to Vigorous Physical Activity (MVPA)
baseline
|
78.97 minute/day
Standard Deviation 10.19
|
60.58 minute/day
Standard Deviation 7.08
|
|
Moderate to Vigorous Physical Activity (MVPA)
26 weeks
|
69.3 minute/day
Standard Deviation 8.37
|
89.05 minute/day
Standard Deviation 15.48
|
Adverse Events
Enhanced Physical Activity
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Physical Activity
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enhanced Physical Activity
n=12 participants at risk
Enhanced Physical Activity: Participants in this group will engage in a 26-week treadmill walking aerobic exercise intervention. The initial speed and duration will be calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining current public health recommendations of 150 minutes of moderate intensity exercise by the 7th week of training and maintaining this level of exercise for the remainder of the 26-week intervention. Exercise will be set at 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period. Training will occur in individual sessions supervised by exercise specialists.
|
Usual Physical Activity
n=12 participants at risk
Usual Physical Activity: Participants in this group will receive education from study staff about the importance of maintaining a healthy and active lifestyle. They will receive standardized literature such as "Exercise \& Physical Activity: Your Everyday Guide from the National Institute on Aging". These booklets provide vetted and reliable information for older adults on how to exercise. Participants assigned to the usual physical activity group will not be provided additional support or guidance with an exercise program.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip Surgery
|
8.3%
1/12 • Number of events 1 • up to 26 weeks
|
0.00%
0/12 • up to 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place