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

NCT ID: NCT03154073

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2019-12-13

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.

Detailed Description

Approximately 25% of older adults have type 2 diabetes mellitus, and almost 50% of older adults have prediabetes. Identifying strategies to prevent the progression of diabetes in this older adult population is imperative. One strategy that has shown promise is lifestyle modification. As adults age they also increase sedentary behavior, decrease physical activity, and have increased occurrence of sleep problems. The combination of these lifestyle factors are likely responsible for the decreases in glycemic control with aging. The American Diabetes Association recommends that prediabetic adults, including older adults, increase structured aerobic exercise and incidental (non-exercise) physical activity while decreasing sedentary behavior. It is emphasized that structured exercise is the most important of these recommendations. However, initiating an exercise routine, may unintentionally affect time spent sitting, non-exercise physical activity, and other lifestyle behaviors like sleep. These changes may attenuate or enhance the effects of exercise on glycemic control. This study will compare the effects of moderate and high intensity exercise on glycemic control, and determine whether changes in non-exercise physical activity, sitting time, and sleep are associated with the observed changes. Because of the increasing prevalence of diabetes with age, identifying the optimal exercise prescription to preserve glycemic control in older adults has important clinical implications.

Conditions

PreDiabetes; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Moderate Exercise Training

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

Group Type: EXPERIMENTAL

Moderate Intensity Exercise Training (MOD)

Intervention Type: 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.

Vigorous Exercise Training

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

Group Type: EXPERIMENTAL

Vigorous Intensity Exercise Training (VIG)

Intervention Type: 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.

Interventions

Moderate Intensity Exercise Training (MOD)

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.

Intervention Type: BEHAVIORAL

Vigorous Intensity Exercise Training (VIG)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Resting systolic blood pressure >160 mmHg or resting diastolic blood pressure >100 mmHg will be exclusionary. At the baseline screening visit, an initial resting blood pressure measurement will be attained after the participant is seated at rest for 5 minutes. Subsequent resting blood pressure measurements can be taken at the baseline screening visit up to 3 times to determine eligibility. Subsequent measurements will be taken under the same conditions as the initial measurement with a minimum of 5 minutes between readings. If more than one reading is needed to determine eligibility, the average of all readings taken will be used.
• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth A Creasy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

F32DK116402

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-2662

Identifier Type: -

Identifier Source: org_study_id