Diabetes
Conditions
Keywords
diabetes
Brief summary
Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.
Interventions
BEHAVIORALHealth Promotion Program
10 week health promotion program 3-4 times per week
Sponsors
Patricia Kluding, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. diabetes type II 2. age 40-70
Exclusion criteria
1. hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months 2. significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus 3. recent symptoms of chest discomfort 4. currently smoking or significant pulmonary pathology 5. serious musculoskeletal problems that would limit ability to exercise 6. current active involvement in a regular exercise program (\> 3 times per week) 7. open wounds on the weight bearing surface of the feet 8. not able to ambulate independently 9. stroke or other central nervous system pathology 10. stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment, Retention, Adherence | 10 weeks | % of enrolled subjects who completed the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic Fitness | Baseline and at 10 weeks (change score) | peak VO2 as measured with a graded maximal exercise test on a cycle ergometer |
| Glycemic Control | Baseline and at 10 weeks (change score) | HbA1c measure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Promotion Program Supervised exercise, educational sessions, dietary counseling | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Health Promotion Program |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 58.7 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Recruitment, Retention, Adherence
% of enrolled subjects who completed the trial
Time frame: 10 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Promotion Program | Recruitment, Retention, Adherence | 55 percentage of participants |
Secondary
Aerobic Fitness
peak VO2 as measured with a graded maximal exercise test on a cycle ergometer
Time frame: Baseline and at 10 weeks (change score)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Promotion Program | Aerobic Fitness | 0.75 mL/kg/m | Standard Deviation 1.78 |
Secondary
Glycemic Control
HbA1c measure
Time frame: Baseline and at 10 weeks (change score)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Promotion Program | Glycemic Control | -0.5 percentage of glycosolated hemoglobin | Standard Deviation 0.5 |