Diet and Exercise Interventions to Increase Muscle Strength and Function

NCT02850562 | Completed

• 1 other identifier: IRB-1607001-EXP
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Sarcopenia; Metabolic Syndrome X

Keywords

body composition,; Dual-Energy X-Ray Absorptiometry; sarcopenia; peripheral quantitative computed tomography; muscle density; elderly

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from Baseline to 3 Months, Change from Baseline to 6 Months

Secondary Outcomes (2)

• 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

Study Arms (2)

Walking

ACTIVE COMPARATOR

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

Walking + Exercise

EXPERIMENTAL

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

Interventions

Walking BEHAVIORAL

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.

Also known as: Control

Walking

Walking + Exercise BEHAVIORAL

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.

Also known as: Exercise

Walking + Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Two population groups will be recruited:
• Women and Men \> 18 years of age and \< 70 years of age who have a BMI \>35.
• Women and Men 70 years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

MeSH Terms

Conditions

Obesity; Sarcopenia; Metabolic Syndrome

Interventions

Walking; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity

Study Officials

• Bonny Specker, Ph.D.

  South Dakota State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 1, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share