Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-04-21 @ 11:37 AM
Study NCT ID:
NCT06537635
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2023-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cubii Vital Sign and Range of Motion Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Satisfaction', 'timeFrame': 'After the 30-minute treatment (T4)', 'description': "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."}, {'measure': 'Ease of Use', 'timeFrame': 'After the 30-minute treatment (T4)', 'description': "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."}, {'measure': 'Refer a friend', 'timeFrame': 'After the 30-minute treatment (T4)', 'description': "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."}, {'measure': 'Knee Flexion Baseline', 'timeFrame': 'This information was collected after the 30-minute treatment (T4).', 'description': 'Knee flexion range of motion was evaluated using the EasyAngle, a digital goniometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['compact elliptical', 'range of motion', 'aerobic exercise'], 'conditions': ['Effects of; Exertion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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®."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* currently engage in a program or aerobic exercise greater than 90 minutes per week\n* report no previously diagnosed chronic health problems\n* patient population of Kaizo Health\n* perform all study procedures in order to participate\n\nExclusion Criteria:\n\n* less than 18 years of age\n* pregnancy\n* cancer\n* any of the conditions on the ACSM absolute and relative contraindications to exercise'}, 'identificationModule': {'nctId': 'NCT06537635', 'briefTitle': 'Cubii Vital Sign and Range of Motion Study', 'organization': {'class': 'OTHER', 'fullName': 'Sport and Spine Rehab Clinical Research Foundation'}, 'officialTitle': 'The Impact of a Seated Compact Elliptical on Vital Signs and Range of Motion During Thirty Minutes of Activity', 'orgStudyIdInfo': {'id': 'CubiiPro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30-minute session of exercise using a seated compact elliptical trainer', 'interventionNames': ['Device: Cubii seated compact elliptical trainer']}], 'interventions': [{'name': 'Cubii seated compact elliptical trainer', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['30-minute session of exercise using a seated compact elliptical trainer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sport and Spine Rehab', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sport and Spine Rehab Clinical Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}