The Effect of Sodium Reduction on Blood Pressure and Physical Function in Older Adults (SOTRUE)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
-
Revere、Massachusetts、アメリカ、02151
- Jack Satter House
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seated Blood Pressure
時間枠：2 weeks
|
Average of three seated systolic and diastolic blood pressure readings
|
2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Orthostatic Hypotension
時間枠：2 weeks
|
Measured from supine and standing systolic and diastolic blood pressure readings
|
2 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Timed up and go Test
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Shivani Sahni, PhD、Marcus Institute, Hebrew SeniorLife and Harvard Medical School
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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