Effects of Progressive Intensity Exercise Training on Glycemic Control in Older Adults

NCT03154073 | Completed

• 2 other identifiers: 16-2662F32DK116402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of moderate versus vigorous intensity exercise training on glycemic control in older adults. Glycemic control will be assessed using an oral glucose tolerance test and continuous glucose monitors. In addition, the investigaotrs will investigate whether engaging in an exercise training program elicits changes in sedentary behavior, non-exercise physical activity, sleep, and total daily energy expenditure.

Conditions

PreDiabetes; Aging

Keywords

Exercise; Physical activity; Blood glucose; Sleep

Outcome Measures

Primary Outcomes (2)

• Change in Glucose Area Under the Curve (AUC)

  Glucose will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes. These measurements will be used to calculate glucose AUC.

  Baseline (0 weeks), Post Intervention (12 weeks)

• Insulin Sensitivity Index (μmol·kg^-1·min^-1·pM^-1)

  Glucose, insulin, and c-peptide will be assessed at 0, 10, 20, 30, 60, 90, 120, 180 minutes . Height will be measured using a wall mounted stadiometer (cm). Weight will be assessed using a digital scale (kg). Collectively these measurements will be used to calculate BMI (kg/m\^2). All of these measurement will be used to assess Insulin sensitivity index as determined by the regression model validated by Stumvoll.

  Baseline (0 weeks), Post Intervention (12 weeks)

Secondary Outcomes (6)

• Change in Sedentary Time

  Baseline (0 weeks), Post Intervention (12 weeks)

• Change in Non-Exercise Physical Activity

  Baseline (0 weeks), Post Intervention (12 weeks)

• Change in Total Daily Energy Expenditure

  Baseline (0 weeks), Post Intervention (12 weeks)

• Change in Sleep Duration - 1

  Baseline (0 weeks), Post Intervention (12 weeks)

• Change in Sleep Duration - 2

  Baseline (0 weeks), Post Intervention (12 weeks)

Study Arms (2)

Moderate Exercise Training

EXPERIMENTAL

Exercise training program that will focus on engaging in \~150 minutes of moderate intensity exercise per week. Exercise will be supervised by trained staff.

Behavioral: Moderate Intensity Exercise Training (MOD)

Vigorous Exercise Training

EXPERIMENTAL

Exercise training program that will focus on engaging in \~150 minutes of vigorous intensity exercise per week. Exercise will be supervised by trained staff.

Behavioral: Vigorous Intensity Exercise Training (VIG)

Interventions

Moderate Intensity Exercise Training (MOD) BEHAVIORAL

For the first 4 weeks, participant will be asked to complete 3 days of exercise/week at 50-65% heart rate maximum. Sessions will last between 30-40 minutes excluding the warm-up and cool down (5-10 minutes). After 4 weeks, the MOD group will be expected to match the exercise prescription. The exercise prescription for the MOD group for weeks 5-12 will be 4 days/week, 45 min/session completed at 60-65% heart rate maximum.

Moderate Exercise Training

Vigorous Intensity Exercise Training (VIG) BEHAVIORAL

The exercise lead in period will be the same as the moderate intensity exercise training program. After 6 weeks, the VIG group will be expected to match the exercise prescription. The exercise prescription for the VIG for weeks 7-12 will be 4 days/week, 45 min/session completed at 80-85% heart rate maximum.

Vigorous Exercise Training

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 to \<80 years upon study entry
• Body mass index ≥25.0 to \<35.0 kg/m2 as measured at the baseline screening visit
• HBA1c ≥ 5.7% to \<6.5% OR Fasting Glucose ≥ 100 to \<126 mg/dl as measured at the baseline screening visit.

You may not qualify if:

• History of metabolic, cardiac, or pulmonary disease that classifies the individual as high risk by the American College of Sports Medicine
• Participants with un-controlled hypertension and un-controlled thyroid disorders and are on medication for \<3 months.
• Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement.
• Self-reported chronic Inflammatory Disease (e.g., rheumatoid arthritis, lupus)
• Currently taking statins, hormone replacement therapy, prescribed sleep medications, or medications that may affect heart rate response to exercise (e.g., beta blockers)
• Participating in \>30 minutes of aerobic exercise/week during the past 3 months
• Inability to complete exercise test
• Sleep Apnea

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prediabetic State; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Seth A Creasy, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: July 20, 2017
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)