The Light Intensity Physical Activity Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes.
研究概览
简要总结
In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly, household activities or taking a flight of stairs might be a potential target for lowering the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has independent predictive value for cardiovascular events and can be measured reliably and non-invasively. The investigators hypothesize that light intensity physical activity intervention program based upon increasing LiPA by replacing sedentary time is effective in lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid distensibility in individuals with T2D.
详细描述
Total duration of the RCT is 12 months, with the first 6 month as the intervention period and the last 6 months as follow-up.
Community-dwelling individuals with type 2 diabetes are eligible for participation in the trial, taking into account the in- and exclusion criteria described below, 160 participants will be included, 80 in each study arm. Study measurements of all participants will take place at baseline (month 1 (t = 0)), month 3 (t = 3), month 6 (t = 6, and month 12 (t = 12) at the Maastricht UMC+.
Participants in the intervention group will be instructed to increase their LiPA by decreasing sedentary time. Participants will follow 4 workshops in group sessions on strategies to change their physical activity behaviour and will receive a feedback physical activity monitor that will be worn continuously on the wrist and provide e-feedback on activity behaviour.
Participants in the control group will receive 4 workshops in group sessions on healthy lifestyle including information and strategies to increase LiPA and reduce sedentary time similar to the intervention group, but will not receive a feedback-activity monitor.
Screening A preliminary screening will be carried out by telephone interview. If eligibility criteria are met the participant will attend the baseline visit which starts with the informed consent procedure. Afterwards, a standard physical examination will take place and an ultrasound scan will be performed to screen for large atherosclerotic plaques of the carotid arteries. If the participant is indeed eligible for inclusion, the investigational baseline measurements are performed after which randomization will take place. From then on participants will run through the protocol either being part of the intervention or control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The investigator measuring the outcome measures will be blinded to patient allocation. Patients are asked not to mention their allocated group or the programme they follow and not to wear or mention the wrist-worn activity tracker during measurements.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-70 years old
- •having type 2 diabetes
- •BMI 20-35 kg/m2
- •having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous physical activity < 150 minutes per week)
- •willingness to undergo randomization
- •being in the possession of personally owned smart phone
排除标准
- •not being able to walk for 15 minutes for any (medical) reason
- •currently engaged in an (medical) exercise program
- •plan to move out of the study area in the next 12 months
- •(digital) illiteracy or being unable to read Dutch
- •a history of any cardiovascular event (including stroke) three months prior to possible inclusion
- •a history of signs or symptoms of ischemic heart disease and(or) heart failure three months prior to possible inclusion
- •a history or signs or symptoms of peripheral arterial disease three months prior to possible inclusion
- •a history or signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers three months prior to possible inclusion
- •a history of sign or symptoms of severe diabetic retinopathy three months prior to possible inclusion
- •a history or sign or symptoms of severe osteoarthritis or severe joint complaints three months prior to possible inclusion
- •a history or signs or symptoms of COPD (eligible are those participants with a COPD Gold classification ≤ I)
- •uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
- •uncontrolled hypertension (i.e., systolic / diastolic blood pressure ≥ 180 / 95 mmHg)
结局指标
主要结局
The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes.
时间窗: Change from baseline carotid distensibility at 6 months.
Carotid distensibility will be determined at the left common carotid by means of arterial ultrasound.
The effect of a LiPA intervention program on reducing aortic carotid-to-femoral pulse-wave velocity (PWV) in patients with type 2 diabetes.
时间窗: Change from baseline PWV at 6 months.
Aortic (carotid to femoral) PWV will be determined by means of applanation tonometry. It will be calculated as the median of three consecutive PWV recordings.
次要结局
- Feasibility of a LiPA intervention program on reducing sedentary time as measured by activPAL(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on depressive symptoms with the use a validated Dutch version of the 9-item Patient Health Questionnaire (PHQ-9).(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on triglycerides.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on changes in blood pressure.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on body composition(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on waist -circumference in cm.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on quality of life as measured through the Dutch versions of the EQ-5D questionnaire.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention program on microvascular function(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- Feasibility of a LiPA intervention program on increasing standing and stepping time as measured by activPAL.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on fasting blood glucose(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on HbA1c.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on total cholesterol.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on HDL- and LDL-cholesterol.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on glucose lowering medication.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on hip -circumference in cm.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention program on immune cells.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
- The effect of a LiPA intervention on quality of life as measured through the Dutch version of the SF-36 questionnaire.(Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).)
研究者
Annemarie Koster, PhD
Principal Investigator
Maastricht University