Diabetes Mellitus, Type 2, Health Behavior, Motor Activity
Conditions
Keywords
Physical Activity, Physical Function, Physical Impairment, Sedentary Lifestyle
Brief summary
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.
Detailed description
The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.
Interventions
BEHAVIORALPhysical Activity
Physical Activity Program Intervention
BEHAVIORALQuestionnaires
Participants in the usual care arm will receive three mailings during the intervention phase.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes * Sedentary individual, performing \<20 minutes of physical activity on \<3 days/week
Exclusion criteria
* Dementia (Folstein Mini-Mental Status Exam \<24) or clinical diagnosis * Excessive fall risk: Can not hold semi-tandem stance for \>10 seconds * Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia * Severely uncontrolled hypertension (BP \>180/100) * Excessive hearing or visual impairment for counseling * Limited life expectancy: Active treatment for malignancy * Performs regular physical activity \>20 minutes on \>3 days/week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Objective Physical Activity at 4 Months | Baseline, 4 Months | ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Physical Function at 4 Months | Baseline, 4 Months | Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed. |
Countries
United States
Participant flow
Recruitment details
A total of 55 people were determined to be eligible for this study, however 5 of them withdrew prior to randomization. This explains the discrepancy between Protocol section (n=55) and Participant Flow Module (n=50).
Participants by arm
| Arm | Count |
|---|---|
| Physical Activity Program Intervention The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Physical Activity: Physical Activity Program Intervention | 28 |
| Usual Care Group Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Questionnaires: Participants in the usual care arm will receive three mailings during the intervention phase. | 22 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Physical Activity Program Intervention | Usual Care Group |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 7.4 | 65.5 years STANDARD_DEVIATION 7.6 | 66.5 years STANDARD_DEVIATION 7.1 |
| Baseline fitness level (VO2peak, ml/kg/min) | 18.4 ml/kg/min STANDARD_DEVIATION 4.4 | 18.5 ml/kg/min STANDARD_DEVIATION 4.7 | 18.3 ml/kg/min STANDARD_DEVIATION 3 |
| Body Mass Index (kg/m^2) | 32.1 kg/m^2 STANDARD_DEVIATION 6.4 | 32.8 kg/m^2 STANDARD_DEVIATION 6 | 31.6 kg/m^2 STANDARD_DEVIATION 6.7 |
| Confidence: Motivation to conduct physical activity(PA) amidst competing demands | 41.7 points STANDARD_DEVIATION 11.9 | 41.2 points STANDARD_DEVIATION 9.8 | 43.8 points STANDARD_DEVIATION 8.6 |
| Confidence: Self-efficacy for physical activity in presence of diabetes | 588.8 points STANDARD_DEVIATION 153.2 | 592.1 points STANDARD_DEVIATION 158.6 | 587.3 points STANDARD_DEVIATION 183.2 |
| Depressive symptoms by Center for Epidemiologic Studies Depression Scale (CES-D) | 10.2 points STANDARD_DEVIATION 8.2 | 10.3 points STANDARD_DEVIATION 8.3 | 10.2 points STANDARD_DEVIATION 8.3 |
| Diastolic Blood Pressure (mm/Hg) | 82.0 mm/Hg STANDARD_DEVIATION 8.5 | 83.6 mm/Hg STANDARD_DEVIATION 8.6 | 80.0 mm/Hg STANDARD_DEVIATION 8.1 |
| Endurance Confidence Survey | 682.8 points STANDARD_DEVIATION 345.8 | 695.0 points STANDARD_DEVIATION 372.7 | 584.1 points STANDARD_DEVIATION 288.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 26 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c (%) | 6.8 percent STANDARD_DEVIATION 1.1 | 6.9 percent STANDARD_DEVIATION 1.3 | 6.7 percent STANDARD_DEVIATION 0.8 |
| % participants with baseline functional impairment | 34 Participants | 17 Participants | 17 Participants |
| Race/Ethnicity, Customized Alaskan Native/Native American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 14 Participants | 10 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian | 25 Participants | 13 Participants | 12 Participants |
| Region of Enrollment United States | 50 participants | 28 participants | 22 participants |
| Sex: Female, Male Female | 26 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Male | 24 Participants | 15 Participants | 9 Participants |
| Systolic Blood Pressure (mm/Hg) | 127.0 mm/Hg STANDARD_DEVIATION 9.9 | 128.1 mm/Hg STANDARD_DEVIATION 9.4 | 125.6 mm/Hg STANDARD_DEVIATION 10.5 |
| Weight (kg) | 91.2 kilograms STANDARD_DEVIATION 47 | 92.0 kilograms STANDARD_DEVIATION 21.4 | 90.6 kilograms STANDARD_DEVIATION 21.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 |
| other Total, other adverse events | 3 / 28 | 0 / 22 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 |
Outcome results
Primary
Change From Baseline in Objective Physical Activity at 4 Months
ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.
Time frame: Baseline, 4 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Program Intervention | Change From Baseline in Objective Physical Activity at 4 Months | 3155 steps/week |
| Usual Care Group | Change From Baseline in Objective Physical Activity at 4 Months | 1581 steps/week |
Secondary
Change From Baseline in Physical Function at 4 Months
Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed.
Time frame: Baseline, 4 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Program Intervention | Change From Baseline in Physical Function at 4 Months | -23.4 seconds |
| Usual Care Group | Change From Baseline in Physical Function at 4 Months | 7.3 seconds |
Secondary
Change From Baseline in Physical Function at 4 Months
Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12).
Time frame: Baseline, 4 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physical Activity Program Intervention | Change From Baseline in Physical Function at 4 Months | 0.9 units on a scale |
| Usual Care Group | Change From Baseline in Physical Function at 4 Months | -0.1 units on a scale |