Diabetes Mellitus
Conditions
Keywords
Physical Activity
Brief summary
The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.
Detailed description
The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants. Study participants will be randomized into three exercise group. Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not attend any instructor-led exercise training sessions. All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.
Interventions
BEHAVIORALStructured Group Exercise
The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Recent hemoglobin A1c result between 6.5 and 13.0% * Diagnosed with Type 2 Diabetes Mellitus * Able and willing to enroll and meet the requirements of the study
Exclusion criteria
* Inability to speak, read or understand English * Long-term current use or dependency on insulin * Systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg * Resting heart rate \> 120 bpm * History of or present heart or cardiovascular conditions * History of or present respiratory disease * History of or present spinal cord injury * History of stroke or Transient Ischemic Attack (TIA) * History of cancer diagnosis in the past 5 years or present cancer diagnosis * Medical, psychiatric, behavioral limitations that may interfere with study participation * Participating in other clinical trials that may interfere with study procedures and outcomes * Currently pregnant or plans to become pregnant within three years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Hemoglobin A1c Level Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Maximal Oxygen Consumption Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Self-Reported Physical Activity Level Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Blood Pressure Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Heart Rate Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Dietary Intake Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Body Weight Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Exercise Perception Across Study Visits | Baseline, 6-, 30-month follow-up |
| Changes in Patient Satisfaction During Intervention Period | 3-, 6-month follow-up |
| Changes in Self-Reported Quality of Life Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Body Mass Index Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
| Changes in Waist Circumference Across Study Visits | Baseline, 3-, 6-, 18-, 24-, 30-month follow-up |
Countries
United States
Outcome results
None listed