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临床试验/NCT03793595
NCT03793595Unknown不适用

Oxygen Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus Upper Extremity Arm Bike Test in Adults With Spinal Cord Injury

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)

研究概览

简要总结

The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in subjects with spinal cord injury.

详细描述

  1. Subjects will be scheduled for the first testing session after informed consent is obtained.
  2. Subjects will fill out PAR-Q+ to determine readiness for exercise testing
  3. Subjects will fill out additional Questionnaire to determine exclusion based on medical history
  4. Prior to the physical performance tests, each participant will be fitted with a mask that covers their face. This mask will be attached to a portable metabolic analyzer (Cosmed k5b). This device collects the air expired which allows for energy expenditure to be estimated.
  5. Each participant will be fitted with the proper sized mask that is connected to a small computer and power source supported at their upper back.
  6. A polar heart rate strap monitor will be worn around the chest. As the participant performs the physical performance tests, the Cosmed K5b measures the amount of carbon dioxide and oxygen from each breath to estimate the amount of energy expended during this task.

Session one:

  1. Prior to beginning the testing, testing procedure will be explained to participants
  2. Subjects blood pressure will be measured, and if a subject's average systolic or diastolic blood pressure exceeds 140 or 90 mmHg, respectively, the subject will be asked to return another day to perform the study procedures. If the blood pressure remains elevated on either one of these measures, the subject will be excused from this study.
  3. Subjects will then perform either the upper extremity cycling protocol or battle ropes protocol first. The other will be performed on the subsequent testing date
  4. If the subject is performing the upper extremity arm cycle test:

Each subject will perform a modified version of the ramped YMCA cycle test using a Upper Extremity Cycle Ergometer and a portable metabolic cart

  • The ramped version of the YMCA cycle test will begin with the subject cycling at a workload of 25 watts at a rate of 60 revolutions per minute (rpm) using a metronome set at 120 beats per minute.
  • Each subject will pedal for 3-minute warm-up period at the 10 watts with the 60 rpm rate. After the 3-minute warm-up, the workload will increase by 10 watts each minute starting at 25 watts at pedal rate of 60 rpm until the subjects meets the termination criteria as described below.
  1. The portable metabolic cart is an instrument that measures levels of expired gases from the subject as he or she exercises that will be analyzed and displayed on a computer monitor. The subject will wear a face mask during the test. A Polar® heart rate monitor will be worn on the chest, directly on the skin of each subject to obtain heart rate measurements.
  2. The goal is for the participant to perform the ramped exercise test using the protocol described above and below until one or more of the following occurs, at which time the test will be terminated: the participant requests the test to be stopped, a respiratory exchange ratio of >1.0 is achieved, or one of the following physiologic and/or subjective signs/symptoms are present:
  • i. A drop in systolic blood pressure >10 mmHg with the increasing work load
  • ii.An increase in systolic and/or diastolic blood pressure >250 mmHg or 115 mmHg, respectively.
  • iii.Reported chest or arm pain (angina)
  • iv.Severe shortness of breath, cyanosis, pallor, lightheadedness, dizziness or confusion
  • v.No increase in heart rate despite increase in work load
  • vi.Complaints of severe fatigue
  • vii.The subject is unable to maintain a pedal rate of 50 rpm
  • viii.Borg 6-20 Perceived exertion scale score >=20
  1. The subjects heart rate will be recorded at the last 15-30 seconds of each minute during the test.
  2. Each subject's blood pressure will be taken before the test commences, every three minutes during the test and once the test procedure is terminated.
  3. The Borg 6-20 perceived exertion scale will be used to monitor the participant's rating of perceived exertion every three minutes during the test. If at any time during the test, the subject rates his or her perceived level of exertion at a level of 20, the test will be terminated.
  4. Session two: will occur at least three days after session one.
  5. If the subject is performing the sitting battling rope:

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Spinal cord lesion T2 or below
  • Individuals with spinal cord injury for greater than six months
  • Utilize manual wheelchair for greater than 10 hours a day

排除标准

  • Current complaints of spinal, lower extremity or upper extremity pain or musculoskeletal disorder that prevents the subject from performing repetitive upper extremity cycling or grasping and swinging the weighted ropes against the floor
  • A current diagnosis of a chronic or acute cardiovascular, metabolic, renal or pulmonary disease including use of a pacemaker
  • Anyone currently taking beta blocker medication
  • Anyone with blood pressure >140/90 at the time of testing or with in the 2 weeks prior to testing
  • Diagnosed sickle cell disease or sickle cell trait
  • Severe spasticity or joint contracture preventing subject from performing upper extremity cycling or swinging of weighted ropes
  • Subjects with current decubital ulcers
  • History of autonomic dysreflexia in the last 6 months
  • Require physician follow-up prior to starting exercise based on PAR-Q+ questionnaire

结局指标

主要结局

Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)

时间窗: about 10-15 minutes after start of the protocol

VO2max will be measured using a portable metabolic cart (Cosmed k5b).

次要结局

  • Rate of perceived exertion as assessed by the Borg 6-20 Perceived exertion scale(about 10-15 minutes after start of the protocol)
  • Blood pressure(about 10-15 minutes after start of the protocol)
  • Heart Rate(about 10-15 minutes after start of the protocol)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne Brewer

Associate Professor

Texas Woman's University

研究点 (2)

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