The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults (SOTRUE)
研究概览
详细说明
Hypertension in older adults is a known contributor to both cardiovascular disease and falls. The Centers of Disease Control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (BP). However, sodium is recommended to treat orthostatic hypotension (OH), a risk factor of falls. The long-term effects of low sodium intake on physical function are largely unknown in older adults.
The objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on BP regulation among 40 semi-independent, older adults aged 60 and above.
Primary Aim 1: To determine the effects of a low sodium (<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium ~2 mg per kcal of energy intake) on seated BP among independently living older adults.
Hypothesis Aim 1: Compared with the usual meal plan, a reduced sodium meal plan will lower seated BP in older adults after 2 weeks.
Feasibility Aim 1: To evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires).
Feasibility Aim 2: To determine effect size (variance) of secondary outcomes: standing BP, OH (standing minus seated BP), orthostatic symptoms, and a timed up and go test (TUG).
Eligible participants will be randomized to low versus usual sodium meal plans for two weeks. Assessments will be made at the in-person baseline visit, one week telephonic interview and 2 week in person follow-up visit.
The primary outcome is seated BP and secondary outcomes include orthostatic hypertension and Timed Up and Go (TUG) tests. Both primary and secondary outcomes will be measured twice: (1) before the study begins (baseline), and (2) after 2 week period. Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed as well.
Intent-to-treat analysis will be conducted for all endpoints.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Massachusetts
-
Revere、Massachusetts、美国、02151
- Jack Satter House
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Resident at Jack Satter House in Revere
- Age >= 60 years
- Resting systolic blood pressure 100-149 mm Hg and diastolic blood pressure <100 mm Hg
- Stable BP medications (no recent or intended changes)
Exclusion Criteria:
- Cognitive Impairment (Montreal Cognitive Assessment test <18)
- Unstable blood pressure medications in the past 2 months
- Terminal or mental illness
- Severe allergies to common foods
- Unwillingness to comply with the diet
- Physical inability to do a timed up and go test
- Active kidney dialysis or history of kidney transplant
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Low sodium diet
This group will get a low sodium diet (<0.9 mg per kcal of energy intake).
|
Intervention include low sodium or usual sodium diet
|
|
有源比较器：Usual sodium diet
This group will get a usual sodium diet (~2 mg per kcal of energy intake).
|
Intervention include low sodium or usual sodium diet
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Seated Blood Pressure
大体时间：2 weeks
|
Average of three seated systolic and diastolic blood pressure readings
|
2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Orthostatic Hypotension
大体时间：2 weeks
|
Measured from supine and standing systolic and diastolic blood pressure readings
|
2 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Timed up and go Test
大体时间：2 weeks
|
Participant will be asked to start from seated position, stand up from the chair, walk 3 meters in a straight line, turn, walk back to the chair and sit down.
The investigators will use average of the two trials.
|
2 weeks
|
合作者和调查者
调查人员
- 首席研究员：Shivani Sahni, PhD、Marcus Institute, Hebrew SeniorLife and Harvard Medical School
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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