Trial Outcomes & Findings for Effects of Exercise Intervention on Aging-related Motor Decline (NCT NCT01787292)

NCT ID: NCT01787292

Last Updated: 2020-02-20

Results Overview

Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline, 12 weeks, 24 weeks
• Results posted on: 2020-02-20

Participant Flow

Community-dwelling individuals were recruited for participation using approved flyer and advertising materials. All participants gave voluntary written consent prior to participation. After consenting, participants were randomly assigned to one of two 12-week exercise interventions involving a followed by cross-over to the other intervention.

Participant milestones

Measure	Experimental: Aerobic Exercise, Then Balance Training Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session.	Experimental: Balance Training, Then Aerobic Exercise Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session.
Crossover Exercise Interventions STARTED	17	16
Crossover Exercise Interventions COMPLETED	15	14
Crossover Exercise Interventions NOT COMPLETED	2	2
Home Based Exercise Program STARTED	15	14
Home Based Exercise Program COMPLETED	12	13
Home Based Exercise Program NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Experimental: Aerobic Exercise, Then Balance Training Participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session. After two to four week washout period, participants entered a second 12-week intervention involving light stretching and balance exercise under a supervised trainer three times per week for 20-45 minutes per session.	Experimental: Balance Training, Then Aerobic Exercise Participants completed a 12-week light stretching and balance exercise program under a supervised trainer three times per week for 20-45 minutes per session.Participants completed an interval aerobic cycling under supervised trainer three times per week for 20-45 minutes per session. After two to four week washout period, participants completed a 12-week interval aerobic cycling under supervised trainers three times per week for 20-45 minutes per session.
Crossover Exercise Interventions Withdrawal by Subject	2	2
Home Based Exercise Program Withdrawal by Subject	3	1

Baseline Characteristics

Effects of Exercise Intervention on Aging-related Motor Decline

Baseline characteristics by cohort

Measure	Exercise Interventions for Crossover Design n=33 Participants This study was a cross-over design with two groups to which participants were randomized. Group one received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention. Group two received the balance intervention for 12 weeks and then crossed over into the aerobic exercise intervention. All completing participants then engaged in a home based exercise program during which they were instructed to exercise thrice weekly over 24 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	69.05 years STANDARD_DEVIATION 5.98 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Cardiovascular Efficiency	25.25 ml/kg(min) STANDARD_DEVIATION 9.74 • n=5 Participants
Ipsilateral Silent Period	22.39 milliseconds STANDARD_DEVIATION 4.73 • n=5 Participants
FMRI of Right Motor Cortex	1.85 area under curve STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Estimated VO2 peak values in ml/kg(min)

Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.

Outcome measures

Measure	Experimental: Aerobic First n=15 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Estimate Cardiovascular Efficiency After Aerobic Exercise Baseline	24.01 ml/kg(min) Standard Deviation 9.29
Estimate Cardiovascular Efficiency After Aerobic Exercise 12-Week post	31.2 ml/kg(min) Standard Deviation 8.6
Estimate Cardiovascular Efficiency After Aerobic Exercise 24-week post-cross	32.3 ml/kg(min) Standard Deviation 6.8

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Sedentary older adults who engaged in less than 45 minutes of regular exercise per week

Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.

Outcome measures

Measure	Experimental: Aerobic First n=14 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Estimate of Cardiovascular Efficiency After Balance Training Pre	22.83 ml/kg(min) Standard Deviation 7.35
Estimate of Cardiovascular Efficiency After Balance Training 12-Weeks	24.72 ml/kg(min) Standard Deviation 9.36
Estimate of Cardiovascular Efficiency After Balance Training 24-week post-cross	23.58 ml/kg(min) Standard Deviation 8.25

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds

Outcome measures

Measure	Experimental: Aerobic First n=15 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Silent Period Duration After Exercise Cycling Program Baseline	22 milliseconds Standard Deviation 7.8
Silent Period Duration After Exercise Cycling Program 12-Week post	26.2 milliseconds Standard Deviation 7.5
Silent Period Duration After Exercise Cycling Program 24-week post-cross	27.5 milliseconds Standard Deviation 7.4

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Sedentary older adults engaging in less than 45 minutes of total activity per week

Ipsilateral silent period duration as assessed by TMS

Outcome measures

Measure	Experimental: Aerobic First n=14 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Silent Period Duration for Balance Group Pre	23 milliseconds Standard Deviation 8.9
Silent Period Duration for Balance Group 12-Weeks	21.2 milliseconds Standard Deviation 5.1
Silent Period Duration for Balance Group 24-week post-cross	26.2 milliseconds Standard Deviation 8.1

PRIMARY outcome

Timeframe: Baseline to 24 Weeks with cross-over

Population: Analysis of area under curve of right primary motor cortical area

Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.

Outcome measures

Measure	Experimental: Aerobic First n=15 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise Pre	1.5 Z-transformed impulse response function Standard Deviation 1.2
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise 12 week intervention	.58 Z-transformed impulse response function Standard Deviation .98
fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise 24 week post-crossover	.58 Z-transformed impulse response function Standard Deviation .98

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.

Outcome measures

Measure	Experimental: Aerobic First n=14 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
fMRI Interhemispheric Inhibition Improvement After Balance Training Pre	1.49 Z-transformed impulse response function Standard Deviation .88
fMRI Interhemispheric Inhibition Improvement After Balance Training 12-Weeks	.62 Z-transformed impulse response function Standard Deviation .52
fMRI Interhemispheric Inhibition Improvement After Balance Training 24-week post-cross	.62 Z-transformed impulse response function Standard Deviation .52

PRIMARY outcome

Timeframe: 24 and 48 weeks

Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).

Outcome measures

Measure	Experimental: Aerobic First n=12 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention Within one week of completing 24 week intervention	25.25 ml/kg(min) Standard Deviation 12.25
Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention Within one week of completing 48 Week Intervention	21.2 ml/kg(min) Standard Deviation 9.88

PRIMARY outcome

Timeframe: 24 and 48 weeks

Population: Participants completed both exercise interventions but completed Balance training prior to engaging in aerobic exercise training.

VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.

Outcome measures

Measure	Experimental: Aerobic First n=12 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention Within one week of completing 24 week intervention	25.5 ml/kg(min) Standard Deviation 12.8
Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention Within one week of completing 48 Week Intervention	20.8 ml/kg(min) Standard Deviation 12.2

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Comparison of silent period duration at 24 weeks compared to baseline

Outcome measures

Measure	Experimental: Aerobic First n=15 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Comparison of Silent Period Duration After Aerobic Exercise Pre	20.58 milliseconds Standard Deviation 7.5
Comparison of Silent Period Duration After Aerobic Exercise 12-Weeks	26.2 milliseconds Standard Deviation 7.5
Comparison of Silent Period Duration After Aerobic Exercise 24-week post-cross	27.5 milliseconds Standard Deviation 7.4

PRIMARY outcome

Timeframe: 24 and 48 weeks

Population: Participants completing balance training then crossing over into aerobic exercise were then tested for effects of facility based treatments against home exercise.

Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.

Outcome measures

Measure	Experimental: Aerobic First n=12 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Comparison of Silent Period Duration After Balance Exercise Within one week of completing 24 week intervention	26.54 milliseconds Standard Deviation 8.4
Comparison of Silent Period Duration After Balance Exercise Within one week of completing 48 Week Intervention	21.6 milliseconds Standard Deviation 9.3

SECONDARY outcome

Timeframe: 24 and 48 weeks

Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve.

Outcome measures

Measure	Experimental: Aerobic First n=14 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Target Heart Rate Zone for Balance First Participants Within one week of completing 24 week intervention	58.4 percentage of time Standard Deviation 34.6
Target Heart Rate Zone for Balance First Participants Within one week of completing 48 Week Intervention	88.5 percentage of time Standard Deviation 14.7

SECONDARY outcome

Timeframe: 24 and 48 weeks

Targeted Heart Rate Zone among participants compared among short term exercise groups

Outcome measures

Measure	Experimental: Aerobic First n=15 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Target Heart Rate Zone After Aerobic Exercise First Within one week of completing 24 week intervention	93.7 percentage of time Standard Deviation 10.1
Target Heart Rate Zone After Aerobic Exercise First Within one week of completing 48 Week Intervention	70.6 percentage of time Standard Deviation 22.5

SECONDARY outcome

Timeframe: 24 and 48 weeks

Population: Participants completing home based interventions compared to facility based interventions - measured in time in aerobic zone.

Measured heart rate after home based intervention

Technical implementation at the facility level prevented acquisition of these metrics until late in the project.

Outcome measures

Measure	Experimental: Aerobic First n=7 Participants Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Heart Rate Workload After Home Based Intervention Within one week of completing 24 week intervention	78 percentage of time Standard Deviation 18
Heart Rate Workload After Home Based Intervention Within one week of completing 48 Week Intervention	48 percentage of time Standard Deviation 30

Adverse Events

Experimental Intervention: Aerobic Exercise First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Intervention: Balance Exercise First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Keith McGregor

Health Science Specialist

Phone: 4043216111

Email: keith.mcgregor2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place