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Sponsor study identifier
interventional
94
0 countries
N/A
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 1, 2017
Actual (reported)The objective of this study is to test the effects of a healthy diet \& walking (Controls) compared to a healthy diet, walking, and balance/strength exercises (Intervention) on muscle density in two populations: elderly individuals and obese individuals. The intervention will be 3 months in length. During this time, both Control and Intervention groups will meet one time each week for educational sessions on healthy diet strategies and to participate in a group walk for the Control group or group exercises for the Intervention group. The Control group will be asked to walk on their own an additional 4 times per week (5 times total) for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point. The Intervention group will walk two times per week using the same criteria as above, and in addition will do balance/strength exercises on a total of three days per week. Measurements will be made at baseline, at intervention completion (3 months) and at a follow-up (6 months -3 months after completion of the intervention). At 3 months, the control group will be invited to add the balance/strength exercises. The hypotheses are that adding balance \& strength exercises to a healthy diet plan will increase muscle density (decrease fat infiltration) and improve muscle function in the elderly and in the obese populations. Increases in muscle density are expected to show greater improvements in muscle function in the elderly population, while it is speculated that greater improvements in metabolic measures will show in the obese population. Participants in the intervention group will have a greater reduction in falls and less hospital, ER \& clinic visits compared to the control group, but both groups will have an improved quality of life, positive changes in eating behaviors, and decreased perceived stress.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
July 21, 2016
Actual (reported)August 1, 2016
Actual (reported)April 1, 2017
Actual (reported)April 1, 2017
Actual (reported)Change in Muscle Density
Muscle density measures will be obtained by peripheral quantitative computed tomography (pQCT) using the XCT3000 densitometer (Orthometrix, Inc.). The image is obtained while the participant is seated and the right leg is extended through the gantry of the device. A scout view will be obtained to reference the end of the tibia and a slice at 66% of the tibia length from the distal end will be obtained. The 66% site is the thickest part of the calf and is used to measure muscle density in mg/cm3. The imaging will take approximately 10 minutes and the total radiation effective dose for the scout view and two slices is considered low (\< 1 μSv). The change in muscle density in mg/cm3 from baseline to intervention completion (3 months) will be used to test the effect of the intervention. The change in muscle density in mg/cm3 from baseline to follow-up (6 months) will be used to test the persistent effect of the intervention.
Change from Baseline to 3 Months, Change from Baseline to 6 Months
Change in Calf Muscle Peak Torque
Isokinetic peak torque in Newton-meters of ankle dorsiflexion and plantar flexion (calf muscle) will be obtained using the Biodex Dynamometer. Participants will be seated in a chair tilted slightly back with the right leg elevated resting on a support and right foot strapped to a pedal. The right foot is flexed and extended to move the pedal and obtain the measurements. Three trials of one rep will be done at a speed of 60˚/sec with a one-minute rest in between each trial. The highest torque from the three trials will be used in analysis. The change in highest torque in Newton-meters from baseline to intervention completion (3 months) will be used to test the effect of the intervention. The change in highest torque from baseline to follow-up (6 months) will be used to test the persistent effect of the intervention.
The Walking Arm will walk 5 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point.
The Walking + Exercise Arm will walk 2 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point and in addition, complete exercises to improve strength and balance on 3 days each week.
The Walking Arm will walk 5 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point.
The Walking + Exercise Arm will walk 2 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point and in addition, complete exercises to improve strength and balance on 3 days each week.
Bonny Specker, Ph.D.
South Dakota State University
94 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2016
First Posted
August 1, 2016
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Change from Baseline to 3 Months, Change from Baseline to 6 Months
Jump Power
Change from Baseline to 3 Months, Change from Baseline to 6 Months
Timed up-and-go test
Change from Baseline to 3 Months, Change from Baseline to 6 Months
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Primary Completion
April 1, 2017
Actual (reported)Study Completion
April 1, 2017
Actual (reported)Last Updated
October 6, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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