Trial Outcomes & Findings for The Entorhinal Cortex and Aerobic Exercise in Aging (NCT NCT02775760)
NCT ID: NCT02775760
Last Updated: 2023-05-10
Results Overview
The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner. Data reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.
TERMINATED
NA
29 participants
0 months-baseline (pre-intervention)
2023-05-10
Participant Flow
Participants were first pre-screened over the telephone. At their initial visit, they gave written informed consent for all study procedures (screening, MRI, etc.). Thus, we consider every participant as enrolled who provided consent, and the number of participants started is not the same as the number of participants who were assigned to each Arm. 8 enrolled participants did not start the exercise intervention, 21 were not eligible after screening, leaving 29 who started the intervention.
Participant milestones
| Measure |
Cardiovascular Endurance
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Entorhinal Cortex and Aerobic Exercise in Aging
Baseline characteristics by cohort
| Measure |
Cardiovascular Endurance
n=17 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=12 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
68.94 years
STANDARD_DEVIATION 5.40 • n=5 Participants
|
68.75 years
STANDARD_DEVIATION 5.77 • n=7 Participants
|
68.86 years
STANDARD_DEVIATION 5.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 months-baseline (pre-intervention)Population: 3 participants were excluded due to excess head motion during functional MRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training)
The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner. Data reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.
Outcome measures
| Measure |
Cardiovascular Endurance
n=10 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=5 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Functional MRI - Right Subiculum
|
-0.07876229 BOLD Signal (beta weight)
Standard Deviation 0.233351521
|
-0.14511014 BOLD Signal (beta weight)
Standard Deviation 0.141012355
|
PRIMARY outcome
Timeframe: 0 months-baseline (pre-intervention)Population: 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training)
Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.
Outcome measures
| Measure |
Cardiovascular Endurance
n=11 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=7 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Structural MRI - Right Dentate Gyrus Head
|
142.7478413 volume in cubic mm
Standard Deviation 14.36877697
|
137.1801957 volume in cubic mm
Standard Deviation 19.71149913
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform.
Participants will perform a spatial memory test during functional MRI. Measurements include baseline-to-follow-up change test performance.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Data not analyzed due to technical errors with the virtual reality (VR) navigation software platform.
Participants will perform a virtual navigation test during functional MRI. Measurements include baseline-to-follow-up change in test performance.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: 3 participants were excluded due to excess head motion during fMRI (2 RT, 1 ET), 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training, RT = resistance training)
The fMRI is measuring blood oxygenation levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. This measurement was obtained while participants were performing a virtual navigation task in the MRI scanner. Data reported for fMRI is in beta-weight for navigation greater control contrast of BOLD images. The beta-weight is a standardized regression coefficient. Higher beta-weights mean greater activation and lower beta-weights mean less activation in specific brain regions being monitored. Negative beta-weights mean lower activation for the navigation condition than for the control condition, positive beta-weights mean greater activation for the navigation condition than for the control condition.
Outcome measures
| Measure |
Cardiovascular Endurance
n=10 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=5 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Functional MRI - Post-intervention Right Subiculum
|
0.00078057 BOLD Signal (beta weight)
Standard Deviation 0.242816203
|
-0.17106976 BOLD Signal (beta weight)
Standard Deviation 0.231649625
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 1 participant was excluded because this participant did not complete the post-intervention MRI (1 ET) (ET = endurance training)
Measurement of regional brain volumes in the medial temporal lobes to assess change in regional brain volumes. Reported outcome measure is volume of the right anterior (i.e., head) dentate gyrus, a hippocampal subfield known to show plasticity in response to exercise in animal models. The hippocampus is part of the medial temporal lobes.
Outcome measures
| Measure |
Cardiovascular Endurance
n=11 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=7 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Structural MRI - Post-intervention Right Dentate Gyrus Head
|
143.0254936 volume in cubic mm
Standard Deviation 16.36761426
|
134.9353733 volume in cubic mm
Standard Deviation 23.23778171
|
SECONDARY outcome
Timeframe: 4 monthsParticipants will perform a treadmill test to estimate baseline-to-follow-up change in aerobic capacity. Aerobic capacity is the maximum amount of oxygen (O2;(expressed in volume: VO2) a person can utilize during strenuous exercise. This maximum volume of oxygen is known as VO2max or aerobic capacity. For this study, we measured heart rate during the treadmill test and estimated VO2max from heart rate, thus we estimated VO2max rather than measured oxygen and carbondioxyde in the breath while exercising. VO2max is expressed in milliliters per kilogram of body weight per minute (ml/kg/min). We calculated percentage change from baseline to post-intervention.
Outcome measures
| Measure |
Cardiovascular Endurance
n=12 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=7 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Aerobic Capacity
|
18.32 Percentage change from baseline
Interval 11.63 to 20.56
|
2.62 Percentage change from baseline
Interval 1.22 to 16.12
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: All participants who completed the intervention were included in the analysis (12 cardiovascular endurance group, 7 strength, balance, and flexibility group).
Participants will perform several muscle strength tests to estimate baseline-to-follow-up change in muscle strength. Percentage change in chess press weight lifted is reported in results.
Outcome measures
| Measure |
Cardiovascular Endurance
n=12 Participants
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=7 Participants
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Muscle Strength
|
0 Percentage change from baseline
Interval -8.75 to 13.92
|
17.24 Percentage change from baseline
Interval 12.55 to 27.86
|
Adverse Events
Cardiovascular Endurance
Strength, Balance, and Flexibility
Serious adverse events
| Measure |
Cardiovascular Endurance
n=17 participants at risk
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=12 participants at risk
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Gastrointestinal disorders
Fainting
|
0.00%
0/17 • 4 months
|
8.3%
1/12 • 4 months
|
|
Nervous system disorders
Sciatica pain
|
5.9%
1/17 • 4 months
|
0.00%
0/12 • 4 months
|
|
Cardiac disorders
Sudden tachycardia
|
5.9%
1/17 • 4 months
|
0.00%
0/12 • 4 months
|
Other adverse events
| Measure |
Cardiovascular Endurance
n=17 participants at risk
Participants will undergo cardiovascular endurance training. The trainer-supervised endurance training will involve walking on a treadmill at moderate intensity
Cardiovascular endurance: Physical exercise at the Boston University Fitness and Recreation Center
|
Strength, Balance, and Flexibility
n=12 participants at risk
Participants will undergo Strength, balance, and flexibility training.
Strength, balance, and flexibility: Physical exercise at the Boston University Fitness and Recreation Center
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
hip pain
|
5.9%
1/17 • 4 months
|
0.00%
0/12 • 4 months
|
|
Nervous system disorders
Concussion
|
0.00%
0/17 • 4 months
|
8.3%
1/12 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Back soreness
|
5.9%
1/17 • 4 months
|
0.00%
0/12 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/17 • 4 months
|
8.3%
1/12 • 4 months
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • 4 months
|
8.3%
1/12 • 4 months
|
|
Cardiac disorders
tachycardia and chest tightness
|
5.9%
1/17 • 4 months
|
0.00%
0/12 • 4 months
|
Additional Information
Karin Schon, Ph.D.
Boston University Chobanian & Avedisian School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place