Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Changes in Maximal Oxygen Consumption Across Study Visits
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Once-Weekly Structured Contact
Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week. They will engage in aerobic and resistance training for approximately 80 minutes per exercise session. Additionally, they will attend three exercise evaluations and six study visits.
干预措施: Structured Group Exercise (Behavioral)
Thrice-Weekly Structured Contact
Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week. In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week. Additionally, they will attend three exercise evaluations and six study visits.
干预措施: Structured Group Exercise (Behavioral)
Usual Care
Participants in the Usual Care group will not take part in an 6-month exercise intervention. They will continue to seek regular care from their primary care providers and attend six study visits.
结局指标
主要结局
Changes in Maximal Oxygen Consumption Across Study Visits
时间窗: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits
时间窗: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Hemoglobin A1c Level Across Study Visits
时间窗: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
次要结局
- 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 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 Body Weight 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)
- 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 Dietary Intake Across Study Visits(Baseline, 3-, 6-, 18-, 24-, 30-month follow-up)
研究者
Latha Palaniappan, MD, MS
Principal Investigator
Stanford University