Effects of; ExertionNCT06537635
Cubii Vital Sign and Range of Motion Study
A study testing Cubii seated compact elliptical trainer in people with Effects of; Exertion, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of; Exertion
- What is being tested?
- Cubii seated compact elliptical trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 18 years of age
- pregnancy
- cancer
- any of the conditions on the ACSM absolute and relative contraindications to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Seated Compact Elliptical on Vital Signs and Range of Motion During Thirty Minutes of Activity
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.
Read the 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®.
- Conditions
- Effects of; Exertion
- Being tested
- Cubii seated compact elliptical trainer
- Keywords
- compact elliptical, range of motion, aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cubii seated compact elliptical trainerDevice
The Cubii® Pro is an under-desk seated elliptical trainer. This device provides 8 levels of resistance and documents the total number of strides, distance covered in miles, and calories expended during an activity session.
| Study group | Role | What they receive |
|---|---|---|
| 30-minute session of exercise using a seated compact elliptical trainer | Experimental | Not described Receives: Device: Cubii seated compact elliptical trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Satisfaction
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.
Measured: After the 30-minute treatment (T4)
Ease of Use
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.
Measured: After the 30-minute treatment (T4)
Refer a friend
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.
Measured: After the 30-minute treatment (T4)
Knee Flexion Baseline
Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer.
Measured: This information was collected after the 30-minute treatment (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Nov 2019
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; ExertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537635
- Sponsor's protocol ID
- CubiiPro
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Seated Compact Elliptical on Vital Signs and Range of Motion During Thirty Minutes of Activity
- ClinicalTrials.gov ID
- NCT06537635
- Acronym / sponsor ID
- CubiiPro
- Conditions
- Effects of; Exertion
- Keywords
- compact elliptical, range of motion, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30-minute session of exercise using a seated compact elliptical trainer | Experimental | Device: Cubii seated compact elliptical trainer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- less than 18 years of age
- pregnancy
- cancer
- any of the conditions on the ACSM absolute and relative contraindications to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cubii seated compact elliptical trainerThe Cubii® Pro is an under-desk seated elliptical trainer. This device provides 8 levels of resistance and documents the total number of strides, distance covered in miles, and calories expended during an activity session. | Device | 30-minute session of exercise using a seated compact elliptical trainer |
Primary outcome
Overall Satisfaction
Time frame: 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.
Ease of Use
Time frame: 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
Time frame: 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
Time frame: This information was collected after the 30-minute treatment (T4).
Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cubii seated compact elliptical trainer in people with Effects of; Exertion, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Satisfaction (time frame: After the 30-minute treatment (T4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.