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Diet and Exercise Interventions to Increase Muscle Strength and Function

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ClinicalTrials.gov Identifier: NCT02850562
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Bonny Specker, South Dakota State University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Sarcopenia Metabolic Syndrome X Behavioral: Walking Behavioral: Walking + Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diet and Exercise Interventions to Increase Muscle Strength and Function:A Randomized Controlled Trial
Study Start Date : July 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017


Arm Intervention/treatment
Active Comparator: Walking
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.
Behavioral: Walking
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.
Other Name: Control

Experimental: Walking + Exercise
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.
Behavioral: Walking + Exercise
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.
Other Name: Exercise




Primary Outcome Measures :
  1. Change in Muscle Density [ Time Frame: Change from Baseline to 3 Months, Change from Baseline to 6 Months ]
    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.

  2. Change in Calf Muscle Peak Torque [ Time Frame: Change from Baseline to 3 Months, Change from Baseline to 6 Months ]

    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.



Secondary Outcome Measures :
  1. Jump Power [ Time Frame: Change from Baseline to 3 Months, Change from Baseline to 6 Months ]

    Jump Power generated from a two-leg counter movement jump will be obtained using the Leonardo Ground Reaction Force Plate (Stratec). The jump motion is recorded using mechanography software. Peak power in kilowatts is obtained. Participants will stand on the plate device and are asked to jump as high as possible by bending the knees and then propelling up. A member of the research team will assist the participant if needed to insure there are no falls. The highest peak power from the 3 jumps will be used in data analysis.

    The change in peak power from baseline to intervention completion (3 months) will be used to test the effect of the intervention. The change in peak power from baseline to follow-up (6 months) will be used to test the persistent effect of the intervention.


  2. Timed up-and-go test [ Time Frame: Change from Baseline to 3 Months, Change from Baseline to 6 Months ]

    The participant sits upright on a stable chair with arm rests (45 cm height) and is allowed to use arms and armrest or the usual walking aid to rise, walk 3 meters to a visible finish line on the floor, turn around, walk back to the chair and sit.

    Time is measured from start to returning to the sitting position with a stop watch to the nearest tenth of a second. The change in the timed up-an-go test from baseline to intervention completion (3 months) will be used to test the effect of the intervention. The change from baseline to follow-up (6 months) will be used to test the persistent effect of the intervention.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Two population groups will be recruited:

  1. Women and Men > 18 years of age and < 70 years of age who have a BMI >35.
  2. Women and Men 70 years of age or older.

Exclusion Criteria:

  • Women and men younger than 18 years of age will be excluded.
  • Women and men aged > 18 years and < 70 years with a BMI < 35 kg/m2 will be excluded.
  • Women and men with the following conditions will be excluded unless given permission by their doctor: Taking medications for heart conditions or high blood pressure; chest pain with our without physical activity; loss of balance or dizziness; bone or joint problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850562


Sponsors and Collaborators
South Dakota State University
Investigators
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Study Director: Bonny Specker, Ph.D. South Dakota State University

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Responsible Party: Bonny Specker, Professor, South Dakota State University
ClinicalTrials.gov Identifier: NCT02850562     History of Changes
Other Study ID Numbers: IRB-1607001-EXP
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bonny Specker, South Dakota State University:
body composition,
Dual-Energy X-Ray Absorptiometry
sarcopenia
peripheral quantitative computed tomography
muscle density
elderly
Additional relevant MeSH terms:
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Sarcopenia
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms