Clinical trial NCT06537635: Cubii Vital Sign and Range of Motion Study
Official title: The Impact of a Seated Compact Elliptical on Vital Signs and Range of Motion During Thirty Minutes of Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of; Exertion
Keywords: compact elliptical
range of motion
aerobic exercise
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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®.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Satisfaction
timeFrame: After the 30-minute treatment (T4)
measure: Ease of Use
timeFrame: After the 30-minute treatment (T4)
measure: Refer a friend
timeFrame: After the 30-minute treatment (T4)
measure: Knee Flexion Baseline
timeFrame: This information was collected after the 30-minute treatment (T4).
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport and Spine Rehab
state: Maryland
Study officials:
References: