Trial Outcomes & Findings for Dose Response Study of Aerobic Exercise in Older Adults (NCT NCT01129115)

Results Overview

Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

101 participants

Primary outcome timeframe

26 weeks

Results posted on

2016-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Nonexercise Control Group Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Overall Study STARTED	25	25	27	24
Overall Study COMPLETED	23	18	21	15
Overall Study NOT COMPLETED	2	7	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Nonexercise Control Group Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Overall Study Adverse Event	1	2	3	3
Overall Study Withdrawal by Subject	1	3	1	4
Overall Study Protocol Violation	0	2	2	2

Baseline Characteristics

Dose Response Study of Aerobic Exercise in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nonexercise Control Group n=25 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=25 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=27 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=24 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.	Total n=101 Participants Total of all reporting groups
Age, Continuous	72.5 years STANDARD_DEVIATION 5.8 • n=5 Participants	73.5 years STANDARD_DEVIATION 5.9 • n=7 Participants	72.5 years STANDARD_DEVIATION 5.7 • n=5 Participants	73.2 years STANDARD_DEVIATION 5.3 • n=4 Participants	72.9 years STANDARD_DEVIATION 5.6 • n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	65 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	36 Participants n=21 Participants

PRIMARY outcome

Timeframe: 26 weeks

Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=23 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=18 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=21 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=15 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Visuospatial Processing	-.02 units on a scale Standard Error .03	.19 units on a scale Standard Error .03	.08 units on a scale Standard Error .03	.29 units on a scale Standard Error .03

PRIMARY outcome

Timeframe: 26 weeks

Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=25 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=25 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=27 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=24 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Change in Maximal Oxygen Consumption	-1 ml/kg/min Standard Deviation 1.6	1.4 ml/kg/min Standard Deviation 1.5	1.7 ml/kg/min Standard Deviation 1.4	2.0 ml/kg/min Standard Deviation 1.9

PRIMARY outcome

Timeframe: 26 Week

The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=25 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=25 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=27 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=24 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Change in Physical Performance Test	.2 units on a scale Standard Deviation 1.7	.1 units on a scale Standard Deviation 2.0	-.9 units on a scale Standard Deviation 1.9	.5 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 26 weeks

Population: Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.

Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=23 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=18 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=21 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=15 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Verbal Memory	.52 units on a standardized scale Standard Error .09	.61 units on a standardized scale Standard Error .09	.47 units on a standardized scale Standard Error .09	.32 units on a standardized scale Standard Error .09

SECONDARY outcome

Timeframe: 26 Weeks

Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=23 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=18 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=21 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=15 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Simple Attention	-.06 units on a scale Standard Error .09	.11 units on a scale Standard Error .09	.09 units on a scale Standard Error .09	.14 units on a scale Standard Error .09

SECONDARY outcome

Timeframe: 26 Weeks

Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=23 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=18 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=21 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=15 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Set Maintenance & Shifting	.07 units on a scale Standard Error .32	-.08 units on a scale Standard Error .32	.14 units on a scale Standard Error .32	-.13 units on a scale Standard Error .32

SECONDARY outcome

Timeframe: 26 Weeks

Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance.

Outcome measures

Outcome measures
Measure	Nonexercise Control Group n=23 Participants Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=18 Participants Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=21 Participants Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=15 Participants Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Reasoning	.24 units on a scale Standard Error .12	.08 units on a scale Standard Error .12	.12 units on a scale Standard Error .12	.21 units on a scale Standard Error .12

Adverse Events

Nonexercise Control Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Aerobic Exercise Group 1

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Aerobic Exercise Group 2

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Aerobic Exercise Group 3

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nonexercise Control Group n=25 participants at risk Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.	Aerobic Exercise Group 1 n=25 participants at risk Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.	Aerobic Exercise Group 2 n=27 participants at risk Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days	Aerobic Exercise Group 3 n=24 participants at risk Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
Musculoskeletal and connective tissue disorders Musculoskeletal Soreness	4.0% 1/25 • Number of events 1	24.0% 6/25 • Number of events 8	51.9% 14/27 • Number of events 31	54.2% 13/24 • Number of events 27
Cardiac disorders Cardiac	4.0% 1/25 • Number of events 1	12.0% 3/25 • Number of events 4	22.2% 6/27 • Number of events 7	25.0% 6/24 • Number of events 7
Respiratory, thoracic and mediastinal disorders Pulmonary	4.0% 1/25 • Number of events 1	4.0% 1/25 • Number of events 1	0.00% 0/27	8.3% 2/24 • Number of events 2
Infections and infestations Infection	0.00% 0/25	8.0% 2/25 • Number of events 2	7.4% 2/27 • Number of events 2	0.00% 0/24

Additional Information

Dr. Jeffrey Burns

University of Kansas Medical Center

Phone: 913-588-0555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place