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临床试验/NCT06537635
NCT06537635已完成不适用

The Impact of a Seated Compact Elliptical on Vital Signs and Range of Motion During Thirty Minutes of Activity

Sport and Spine Rehab Clinical Research Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Ease of Use

研究概览

简要总结

The purpose of this study is to evaluate the effect of a seated compact elliptical on vital signs and range of motion (of knees and ankles) following thirty minutes of activity.

详细描述

The purpose of this study is to evaluate the effect of 30 minutes of exercise on a seated compact elliptical on vital signs and range of motion (ROM). A convenience sample of 40 patients will be recruited for this study in two phases. The first phase from younger 18-30 staff from Kaizo Health who currently engage in a program or aerobic exercise greater than 90 minutes per week and report no previously diagnosed chronic health problems. Phase two will take place among the patient population of Kaizo Health consisting of men and women between 30-70. The purpose of recruiting in two phases is generate a more diverse sample. Participants must be able to perform all study procedures in order to participate. Exclusionary criteria will include less than 18 years of age, pregnancy, cancer, or the any of the conditions on the ACSM absolute and relative contraindications to exercise. After explanation of the study and consent is obtained, participants will complete the demographics form, medication questionnaire, the Self-Administered Comorbidity Questionnaire, and International Physical Activity Questionnaire short form. After completing the initial paperwork, participant's vital signs (blood pressure, heart rate, and oxygen saturation) and ROM of the ankle and knee will be assessed (T1). Following baseline measures, participants will perform a one-minute warm-up, thirty minutes of activity, and a two-minute cool-down on the Cubii®, a seated compact elliptical. During all activity, heart rate and oxygen saturation will be recorded every minute. Following the cooldown, blood pressure, heart rate, oxygen saturation, and ROM will be reassessed (T2). At the end of T2, steps, elliptical strides, distance, time, and calories burned will be recorded from the Cubii®. Additionally, all participants will complete a satisfaction questionnaire about the Cubii®.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • currently engage in a program or aerobic exercise greater than 90 minutes per week
  • report no previously diagnosed chronic health problems
  • patient population of Kaizo Health
  • perform all study procedures in order to participate

排除标准

  • less than 18 years of age
  • pregnancy
  • any of the conditions on the ACSM absolute and relative contraindications to exercise

结局指标

主要结局

Ease of Use

时间窗: After the 30-minute treatment (T4)

The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

Overall Satisfaction

时间窗: After the 30-minute treatment (T4)

The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

Refer a friend

时间窗: After the 30-minute treatment (T4)

The Customer Satisfaction (CSAT) was measured to gain insights into the patients' satisfaction of using the Cubii®. This CSAT asks a series of questions related to the ease of use, comfort, side effects, and overall satisfaction of the device. The participant responds by rating each question on a scale of 1 to 5, 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 satisfied, and 5 very satisfied.

Knee Flexion Baseline

时间窗: This information was collected after the 30-minute treatment (T4).

Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer.

次要结局

未报告次要终点

研究者

发起方
Sport and Spine Rehab Clinical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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