Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes: a Pragmatic Clinical Trial - The PRACTICE Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 344
- 试验地点
- 2
- 主要终点
- Change from Baseline Glycated Hemoglobin at 3 and 6 months
研究概览
简要总结
The purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with Type 2 Diabetes (T2D), in comparison to a usual model of PA counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with T2D.
详细描述
The PRACTICE Trial aims to assess the effectiveness of a remote and intensive physical activity promotion program in contrast to the usual advice for physical activity on the management of HbA1c in people with T2DM.
The duration of the trial will be 24 weeks. Participants will be allocated to the intervention group or control group. The data collection will include variables related to (a) physical activity levels; (b) quality of life; (c) self-care in T2D; (d) functional capacity levels; and (e) adverse events related or not to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blind masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older;
- •Glycated hemoglobin ≥ 8.0%;
- •Being a resident in Porto Alegre or metropolitan areas (Viamão, Alvorada, Cachoeirinha, or Canoas);
- •Eligibility to perform physical activity after cardiovascular risk assessment;
- •Have some means of access to the internet (direct access or via a family member who can receive the research material and share the information/material sent with the participant).
排除标准
- •Physically active, that is, performing at least 150 minutes of moderate to vigorous PA per week;
- •Not having their own cell phone capable of receiving calls and text messages;
- •Progressive neurological disorder (e.g., Parkinsonism, Alzheimer's Disease);
- •Psychiatric disorder that makes the intervention unfeasible;
- •Physical, language, hearing, vision or cognition disorder that makes it impossible to attend the evaluations and carry out the intervention;
- •Severe cardiovascular disease (class III and IV heart failure, unstable angina), history of macrovascular event in the last 12 months (acute myocardial infarction, revascularization procedures, deep vein thrombosis, stroke or pulmonary embolism);
- •Joint, muscle or bone injury that makes the intervention unfeasible;
- •Planning to move to cities outside the geographic area where the study is carried out;
- •Inadequate control of comorbidities. Resting systolic blood pressure >180 mmHg and/or resting diastolic blood pressure >100 mmHg;
- •Physical limitation that makes it impossible or brings risk to the participant's practice (e.g. lower limb amputation that makes locomotion difficult, use of crutches, cane).
结局指标
主要结局
Change from Baseline Glycated Hemoglobin at 3 and 6 months
时间窗: Baseline; 12 weeks; 24 weeks.
Glycated hemoglobin (HbA1c) is the primary outcome used for the comparison of a remote and intensive physical activity promotion program compared with usual advice for physical activity. The minimum clinically important difference considered for the study design and sample size calculation was an HbA1c reduction of 0.50% in favor of the remote and intensive physical activity promotion program.
次要结局
- Medication changes(Monthly, up to 24 weeks.)
- Sitting time(Baseline; 12 weeks; 24 weeks.)
- Short Form Health Survey (SF-36)(Baseline; 12 weeks; 24 weeks.)
- Physical Activity Levels(Baseline; 12 weeks; 24 weeks.)