Exercise to Improve the Hearts and Minds of Canadian Older Adults With Hypertension: The Heart & Mind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Automated office Systolic Blood Pressure
研究概览
简要总结
Older adults with subjective cognitive decline (SCD) may represent a portion of the population experiencing early sings of cognitive decline. Systolic hypertension is a major contributor to cognitive impairment. High-intensity aerobic interval training (HIT) yields greater fitness and vascular health improvements compared to moderate-intensity aerobic continuous training (MCT). No randomized controlled trials, however, have investigated the effects HIT or MCT on cognition in older adults with hypertension and SCD. Much less is known regarding whether combining HIT or MCT with mind-motor training would culminate additive benefits to cognition. Therefore, the overarching goal of our research is to deliver a group-based exercise program combining mind-motor training with HIT or MCT to older adults with hypertension and SCD. Participants will be randomized into two groups. Participants in both groups will receive 15 minutes of square stepping exercise (SSE) followed by either 45 minutes of HIT (N=70) or 45 minutes of MCT (N=70). In total, both groups will exercise 60 min/day, 3 days/week for 6 months. The effects of both interventions will be evaluated on systolic and diastolic office/ambulatory blood pressure and global and domain-specific cognitive functioning.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The Research Coordinator will manage recruitment and enrolment of study participants, and will not be involved in either measurement or the intervention. Research personnel performing the outcome assessments and data analysis will be blinded to group allocation but it is not possible to blind participants and personnel delivering the interventions.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age or older;
- •Present with controlled or uncontrolled stage 1 hypertension (seated, resting clinic SBP 140 to 179 mmHg and/or DBP 90 to 109 mmHg) as per Hypertension Canada's 2017 Guidelines;
- •Have preserved instrumental activities of daily living (scoring >6/8 on the Lawton-Brody Instrumental Activities of Daily Living [IADL] scale);
- •Present signs of SCD (defined as answering yes to the question: "Do you feel like your memory or thinking skills have gotten worse recently?");
- •Report being concerned about SCD (defined as answering yes to the question: "If yes, are you concerned about the worsening of your memory or thinking skills?");
- •Preserved objective cognitive performance (i.e., no signs of MCI or dementia) defined by scoring ≥ 26 on the Montreal Cognitive Assessment (MoCA);
- •Must be able to provide written informed consent.
排除标准
- •Present signs of objective cognitive impairment (i.e., signs of MCI or dementia), defined by scoring ≤ 25 on the MoCA combined with study physician consult;
- •Present resting stage 2 hypertension (seated, resting clinic SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
- •Present significant neurological conditions or psychiatric disorders (e.g., Parkinson's disease or stroke <1 year); 4) present history of severe cardiovascular conditions (e.g., recent [<1 year] myocardial infarction, left ventricular hypertrophy) and symptomatic cerebrovascular disease;
- •Present significant orthopaedic conditions (e.g., severe osteoarthritis in the lower limbs);
- •Present untreated clinical depression (i.e., score >15 on the Center for Epidemiologic Studies - Depression scale combined with study physician consult);
- •Unable to comprehend the study letter of information. Participants will also be excluded for any other factors that could potentially limit their ability to fully participate in the study.
结局指标
主要结局
Automated office Systolic Blood Pressure
时间窗: Change from 0 to 6 months
Resting blood pressure
Composite score from Cambridge Brain Sciences Cognitive Battery
时间窗: Change from 0 to 6 months
Global cognitive functioning assessment
次要结局
- Trail-Making Test(Change from 0 to 6 months)
- Reasoning(0 to 6 months)
- Concentration(0 to 6 months)
- Memory(0 to 6 months)
- 24-hour Blood Pressure monitoring(Change from 0 to 6 months)
- Maximal oxygen uptake (VO2max)(Change from 0 to 6 months)
- Planning(0 to 6 months)
研究者
Robert Petrella
Associate Professor
Western University, Canada