Pedal Pump Clinical Trial on Edema V1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale
研究概览
简要总结
Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.
The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema.
Key Question for this first study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?
This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.
详细描述
The Pedal Pump is a device which engages the feet of patients while they are in bed. The device is placed between the foot board and the patient's feet. It provides gentle, on-and-off pressure to the feet, which, in turn, mobilizes the whole body in a rhythmic, calming manner.
The proposed hypotheses of the Pedal Pump are primarily based on the health benefits provided by normal walking. They include, but are not limited to…
Physiological Benefits
- Increase lymphatic flow within the body
- Increase blood flow back to the heart and into the tissues
- Increase intestinal peristalsis
- Increase kidney filtration
- Increase myofascial and musculoskeletal movement
Proposed Patient-Centered Benefits
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistician
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
- •Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, or other etiologies of fluid overload conditions.
- •Medically stable
- •Able to remain in Fowler position for 10 minutes
- •Patients in the ER, observation, or admitted to the hospital for any period of time; outpatients (specifically CHF clinic patients)
- •Patients must give informed consent to participate. The patient must be able to read the consent form (in English or Spanish) or give consent after the form is translated for the patient.
排除标准
- •Patients using a hospital bed which has the scale on the foot board
- •Lymphedema (interstitial protein-built fluid)
- •Lipedema (fat distribution)
- •Pressure ulcers
- •Active DVT (i.e. Patients who have signs of acute unilateral swelling must have a documented negative lower extremity venous duplex ultrasound within the current admission before they will be included in the trial.)
- •Symptomatic peripheral vascular disease
- •Wounds or infections in the feet, legs, buttocks, or back
- •Weeping lymphedema or bullous cellulitis
- •Uncontrolled hypertension (BP>180/110) in the recent 2 hours
- •Uncontrolled hypotension (BP <80/45) in the recent 2 hours
- •Heart rate greater than 110 or less than 45 in the recent 2 hours
- •Leg or back surgery in previous 30 days
- •Known pregnancy
- •Severe osteoporosis/fracture risk
研究组 & 干预措施
Treatment Group
The Treatment group will experience the Pedal Pump intervention by...
- Being assisted to sit up in their beds at a 45-60 degree Fowler's position. Their thighs, calves, and ankles being marked with a surgical marker at the locations and measured.
- The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed.
- Provided the treatment is tolerated by the patient, the Pedal Pump treatment being applied to both feet for 10 minutes continuously mobilizing their whole body in sufficient manner to see the nose move.
- The Operator turning off the device and removing it from the bed.
干预措施: Pedal Pump (Device)
Sham (Control) Group
The Sham Group will have the same experience as Treatment Group with the exact same device generating identical operational sounds and visible movement, but the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
干预措施: Pedal Pump Sham (Device)
结局指标
主要结局
No Treatment-Related Adverse Events Scoring 3, 4, or 5 on the CTCAE v4.0 scale
时间窗: 10 minutes
Treatment-related adverse events will be assessed by CTCAE v4.0 on a 1-5 scale: * Grade 1 (Mild): Asymptomatic or mild symptoms. * Grade 2 (Moderate): Minimal, local, or noninvasive intervention indicated. * Grade 3 (Severe): Severe but not immediately life-threatening; hospitalization indicated. * Grade 4 (Life-threatening): Urgent intervention indicated. * Grade 5 (Death): Death related to the AE. Adverse Events monitors will be such as, but not limited to: * New pain * Worsened pain * Dizziness * Blood pressure instability * Skin irritation * Muscle cramping * Abdominal cramping * Anxiety * Nausea * Syncope * Chest pain of cardiac origin * Sustained arrhythmia * Stroke symptoms * Hypoxia * Hypotension Treatment will stop immediately if a Grade 3, 4, or 5 adverse event occurs. The Investigators will keep record of the number of patients having adverse events and their severities.
Treatment Tolerability
时间窗: 10 minutes
≥95% treatment tolerability (\<5% "aborted" treatments)
Change in Lower Extremity Edema
时间窗: 10 minutes
≥1 cm change in average lower extremity circumferences
次要结局
- No increase in pain or stress in ≥80% of the treatment group(10 minutes)
- <20% of Treatment Group having Treatment-Related Adverse Events scoring 2 per CTCAE v4.0(10 minutes)
研究者
David McVay
Primary Investigator - Hospitalist Physician - Sponsor
Hillcrest