EIAMD: Effects of Exercise Intervention on Aging-related Motor Decline

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01787292
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Actual Duration (Months): 78.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this research study is to test whether differing levels of physical fitness affects patterns of motor dexterity and brain activity that have been shown to differ due to aging. Testing will take place at the Atlanta VA Medical Center and at Emory University.

Participants will be healthy adults within the target age range of 60-85 for the study. The study will require multiple visits over 15 months. There will be about 64 people volunteering for this study.

Condition or Disease	Intervention/Treatment	Phase
Aging; Exercise	Behavioral: Stretching Exercise Intervention; Behavioral: Aerobic Exercise Intervention; Behavioral: Self Monitoring	N/A

Detailed Description

The U.S. Census reports over 14 million U.S. Veterans (>63%) are beyond mid-life (>55 years). Declines in upper extremity motor performance respective of strength and dexterity are well documented within this age cohort). Recent cross-sectional research has discovered that aging related motor deficits may be influenced by a loss of interhemispheric inhibition (IHI) between primary motor cortices. However, this loss may not be an inevitable consequence of aging. Work from previous VA OAA Predoctoral and CDA-1 awards have shown that aerobic fitness may serve to mitigate losses in interhemispheric inhibition assessed by both functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). That is, individuals who are aerobically fit show higher levels of IHI and improved dexterity and reaction times.

In light of new evidence from the investigators' lab's recent cross-sectional studies, physical activity over the long term (at least 2-5 years) may serve to alter levels of IHI and improve motor performance in the upper extremity. Aerobic exercise may provide a mechanism (reduced loss of interhemispheric inhibition) that could serve to improve motor function, but the neural mechanism responsible for such effects remains unclear. Previous investigations of interhemispheric communication and exercise have been limited by nature of inquiry, as cross-sectional research cannot measure changes over time in participants. As such, it is currently unknown how exercise may directly affect levels of interhemispheric communication and motor performance.

Behavioral interventions (motor strength and coordination) have been shown to be effective in improving upper extremity motor performance in older adults, however the duration of these gains appear to be short-lived. After as little as a few weeks of detraining, motor strength and coordination in the upper extremity rapidly begins to return to pre-intervention levels. Evidence from exercise interventions assessing gait and locomotion have shown that exercise programs over a longer term (>6 months) are associated with improved proprioception, fewer falls and better balance. However, the comparison of outcomes of upper extremity function in elderly adults respective of exercise duration remains largely unexplored. In addition to comparing the effects of short-term exercise (3 months) versus behavioral training (3 months) on upper extremity function, the current proposal will evaluate if a longer-term (6 months) exercise program can maintain or enhance upper extremity function and associated levels of interhemispheric inhibition.

The current study proposes the next logical step in my line of research and directly investigates the effects of exercise in an intervention with sedentary older Veterans (50-80 years), a group most likely to exhibit aging-related motor deficits. The investigators propose to enroll 40 Veterans into an upper extremity dexterity improvement program involving behavioral and exercise components. The behavioral intervention is a muscle coordination training previously shown to improve unimanual motor performance in older adults. The exercise intervention is a supervised group cycling regimen. The figure below shows the study design. Interhemispheric communication will be assessed with fMRI, and TMS.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum. B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum. C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometerLight stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum.6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Exercise Intervention on Aging-related Motor Decline (AGING)
• Actual Study Start Date: Jan 14, 2013
• Actual Primary Completion Date: Jul 7, 2018
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stretching Exercise Intervention A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.	Behavioral: Stretching Exercise Intervention; A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
Experimental: Aerobic Exercise Intervention B. Interval aerobic cycling under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted between 50-85% of age-related maximum.	Behavioral: Aerobic Exercise Intervention; Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Experimental: Self Monitoring Intervention C. 6 month self-monitored training phase during which time participants will exercise using a take home bike ergometer.	Behavioral: Self Monitoring; 6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)

Outcome Measures

Primary Outcome Measures

1. Estimate Cardiovascular Efficiency After Aerobic Exercise [Baseline, 12 weeks, 24 weeks]

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

2. Estimate of Cardiovascular Efficiency After Balance Training [Baseline, 12 weeks, 24 weeks]

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

3. Silent Period Duration After Exercise Cycling Program [Baseline, 12 weeks, 24 weeks]

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

4. Silent Period Duration for Balance Group [Baseline, 12 weeks, 24 weeks]

   Ipsilateral silent period duration as assessed by TMS

5. fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise [Baseline to 24 Weeks with cross-over]

   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.

6. fMRI Interhemispheric Inhibition Improvement After Balance Training [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.

7. Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention [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).

8. Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention [24 and 48 weeks]

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

9. Comparison of Silent Period Duration After Aerobic Exercise [Baseline, 12 weeks, 24 weeks]

   Comparison of silent period duration at 24 weeks compared to baseline

10. Comparison of Silent Period Duration After Balance Exercise [24 and 48 weeks]

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

Secondary Outcome Measures

1. Target Heart Rate Zone for Balance First Participants [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.

2. Target Heart Rate Zone After Aerobic Exercise First [24 and 48 weeks]

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

3. Heart Rate Workload After Home Based Intervention [24 and 48 weeks]

   Measured heart rate after home based intervention Technical implementation at the facility level prevented acquisition of these metrics until late in the project.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Living persons between 60 and 85 years of age

Exclusion Criteria:

• unmanaged diabetes

• participants completing vigorous exercise per week

• participants whose profession requires vigorous physical labor

• contraindication to magnetic resonance imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia	United States	30033

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Keith M. McGregor, PhD MS BA, Atlanta VA Medical and Rehab Center, Decatur, GA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 5, 2019

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01787292
• Other Study ID Numbers: E0956-W; 2012-060697
• First Posted: Feb 8, 2013
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Exercise; Magnetic Resonance Imaging; Transcranial Magnetic Stimulation; Aging

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Experimental: Aerobic Exercise, Then Balance Training	Experimental: Balance Training, Then Aerobic Exercise
Arm/Group Description	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.	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.
Period Title: Crossover Exercise Interventions
STARTED	17	16
COMPLETED	15	14
NOT COMPLETED	2	2
Period Title: Crossover Exercise Interventions
STARTED	15	14
COMPLETED	12	13
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Exercise Interventions for Crossover Design
Arm/Group Description	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.
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 24.2%
>=65 years	25 75.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.05 (5.98)
Sex: Female, Male (Count of Participants)
Female	19 57.6%
Male	14 42.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	16 48.5%
White	17 51.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Cardiovascular Efficiency (ml/kg(min)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/kg(min)]	25.25 (9.74)
Ipsilateral Silent Period (milliseconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milliseconds]	22.39 (4.73)
FMRI of Right Motor Cortex (area under curve) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [area under curve]	1.85 (1.2)

Outcome Measures

1. Primary Outcome

Title	Estimate Cardiovascular Efficiency After Aerobic Exercise
Description	Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

Estimated VO2 peak values in ml/kg(min)

Arm/Group Title	Experimental: Aerobic First
Arm/Group Description	Aerobic Exercise: Interval based spin exercise under a supervised trainer three times per week for 20-45 minutes per session.
Measure Participants	15
Baseline	24.01 (9.29)
12-Week post	31.2 (8.6)
24-week post-cross	32.3 (6.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments	To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.
	Method	ANCOVA
	Comments	Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation

2. Primary Outcome

Title	Estimate of Cardiovascular Efficiency After Balance Training
Description	Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after 12-week intervention
Measure Participants	14
Pre	22.83 (7.35)
12-Weeks	24.72 (9.36)
24-week post-cross	23.58 (8.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments	To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.8
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Silent Period Duration After Exercise Cycling Program
Description	Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise - Cycling
Arm/Group Description	Short Term exercise - supervised: Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Measure Participants	15
Baseline	22 (7.8)
12-Week post	26.2 (7.5)
24-week post-cross	27.5 (7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments	To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.
	Method	ANCOVA
	Comments

4. Primary Outcome

Title	Silent Period Duration for Balance Group
Description	Ipsilateral silent period duration as assessed by TMS
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after 12-week intervention
Measure Participants	14
Pre	23 (8.9)
12-Weeks	21.2 (5.1)
24-week post-cross	26.2 (8.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments	To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.
	Method	ANCOVA
	Comments	A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.

5. Primary Outcome

Title	fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise
Description	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.
Time Frame	Baseline to 24 Weeks with cross-over

Outcome Measure Data

Analysis Population Description

Analysis of area under curve of right primary motor cortical area

Arm/Group Title	Aerobic First Then Balance Cross-over
Arm/Group Description	Aerobic cycling first then cross-over to balance group
Measure Participants	15
Pre	1.5 (1.2)
12 week intervention	.58 (.98)
24 week post-crossover	.58 (.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	t-test, 2 sided
	Comments

6. Primary Outcome

Title	fMRI Interhemispheric Inhibition Improvement After Balance Training
Description	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.
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after 12-week intervention
Measure Participants	14
Pre	1.49 (.88)
12-Weeks	.62 (.52)
24-week post-cross	.62 (.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	t-test, 2 sided
	Comments

7. Primary Outcome

Title	Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention
Description	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).
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Interventions for Crossover Design
Arm/Group Description	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.
Measure Participants	12
Within one week of completing 24 week intervention	25.25 (12.25)
Within one week of completing 48 Week Intervention	21.2 (9.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	t-test, 2 sided
	Comments

8. Primary Outcome

Title	Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention
Description	VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after study completion
Measure Participants	12
Within one week of completing 24 week intervention	25.5 (12.8)
Within one week of completing 48 Week Intervention	20.8 (12.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.5
	Comments
	Method	t-test, 2 sided
	Comments

9. Primary Outcome

Title	Comparison of Silent Period Duration After Aerobic Exercise
Description	Comparison of silent period duration at 24 weeks compared to baseline
Time Frame	Baseline, 12 weeks, 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aerobic Exercise
Arm/Group Description	Participants in this group first received a 12-week Aerobic exercise intervention and then crossed over into a balance exercise intervention.
Measure Participants	15
Pre	20.58 (7.5)
12-Weeks	26.2 (7.5)
24-week post-cross	27.5 (7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.6
	Comments
	Method	t-test, 2 sided
	Comments	A Kenward-Rogers adjustment for df was made to account for carryover effects.

10. Primary Outcome

Title	Comparison of Silent Period Duration After Balance Exercise
Description	Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after study completion
Measure Participants	12
Within one week of completing 24 week intervention	26.54 (8.4)
Within one week of completing 48 Week Intervention	21.6 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.4
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Target Heart Rate Zone for Balance First Participants
Description	Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve.
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Balance Training
Arm/Group Description	Effects of Balance/Stretching training after 12-week intervention
Measure Participants	14
Within one week of completing 24 week intervention	58.4 (34.6)
Within one week of completing 48 Week Intervention	88.5 (14.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.05
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Target Heart Rate Zone After Aerobic Exercise First
Description	Targeted Heart Rate Zone among participants compared among short term exercise groups
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise - Cycling
Arm/Group Description	Short Term exercise - supervised: Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
Measure Participants	15
Within one week of completing 24 week intervention	93.7 (10.1)
Within one week of completing 48 Week Intervention	70.6 (22.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.25
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Heart Rate Workload After Home Based Intervention
Description	Measured heart rate after home based intervention Technical implementation at the facility level prevented acquisition of these metrics until late in the project.
Time Frame	24 and 48 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Exercise Interventions for Crossover Design
Arm/Group Description	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.
Measure Participants	7
Within one week of completing 24 week intervention	78 (18)
Within one week of completing 48 Week Intervention	48 (30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental: Aerobic First
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	60 month. Participants were assessed at baseline, after 12-weeks, after 24 weeks and after 48 weeks. Measurements at 12 weeks represent first intervention. Measurements at 24 weeks represent measure after cross-over into alternate intervention. All participants then went through a home-based exercise program, which is the 48 week assessment. Note: Participants may have withdrawn from the study prior to completing the home-based exercise program.
Arm/Group Title	Experimental Intervention: Aerobic Exercise First		Experimental Intervention: Balance Exercise First
Arm/Group Description	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. Participants later crossed over into the Balance condition and were assessed at 24 weeks. After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm.		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. Participants later crossed over into the Aerobic Exercise condition and were assessed at 24 weeks. After this time, participants completed a 24 week home based aerobic exercise program. This intervention was common to both groups and therefore are collapsed within this Arm.
All Cause Mortality
	Experimental Intervention: Aerobic Exercise First		Experimental Intervention: Balance Exercise First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Serious Adverse Events
	Experimental Intervention: Aerobic Exercise First		Experimental Intervention: Balance Exercise First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Intervention: Aerobic Exercise First		Experimental Intervention: Balance Exercise First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)

Limitations/Caveats

Local procurement difficulties limited remote tracking of participants in 6-month home exercise arm of program. This caused lower-than-expected adherence and negatively affected long-term outcomes.

More Information

Certain Agreements

All Principal Investigators ARE 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.