Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users

Study Overview
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Brief Summary
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The purpose of the study is to test the benefits of a 24-week exercise program for reversing heart, blood, and blood vessels health risk causes, also referred to as cardiometabolic risk factors, in adult wheelchair users. The targeted cardiometabolic health factors are waist circumference, triglycerides, cholesterol, glucose, and blood pressure. Additionally, a second phase of 12 weeks is included to test how well an online version of the program is for maintaining physical activity levels.

Detailed Description
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Baseline Assessment: Participants will be asked to complete a baseline assessment. This measures physical health (e.g., cardiometabolic health factors, fat/muscle mass) and functions (e.g., muscular strength, aerobic endurance) and a series of self-reported questionnaires that are related to participant's demographics, psychosocial health (depression, sleep, fatigue), quality of life, and physical activity behaviors (volume of activity). The physical tests will take approximately 1.5 hours to complete. The questionnaires will be completed electronically and may take up to an hour. The assessments are listed below. PHYSICAL TEST: The physical tests will take place at the UAB/Lakeshore Research Collaborative Center, Wallace Building (3810 Ridgeway Drive, Birmingham, AL 35209). Anthropometrics (weight, height, blood pressure, resting heart rate, waist circumference) Blood draw Functional Independence Measurement (activities of daily living such as walking, transfer, self-care, and communication) Body composition (amount of fat mass and fat free mass) by dual x-ray absorptiometry (DXA). DXA scans will be performed to measure any changes in fat-mass and fat-free mass. X-ray scans will be performed on 3 occasions using an iDXA whole-body scanner (GE-Lunar Radiation Corporation, Madison, WI). The radiation dose is less than 1 mrem. Scans will be analyzed using CoreScan software, and muscle mass will be estimated using published equations. Upper Body muscular strength by BIODEX computerized dynamometer Computerized dynamometer will be performed to measure any changes in the maximal load that can be lifted in one repetition in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers. Aerobic endurance and lung function by an arm-crank ergometer and open-circuit spirometry system Open-circuit spirometry system will be used to measure any changes in heart rate, rate of perceived exertion (i.e., how much effort you feel you are giving), and amount of air you can breathe out while performing a 20-minute, continuous arm-crank ergometer. QUESTIONNAIRES: Leisure Time Physical Activity Questionnaire for Spinal Cord Injury NIH PROMIS Pain Intensity Short Form NIH PROMIS Pain Interference Short Form NIH PROMIS Fatigue Short Form NIH PROMIS Sleep Disturbance Short Form NIH PROMIS 10 Global Health Items NIH PROMIS Ability to Participate in Social Roles and Activities NIH PROMIS Depression Short Form NIH PROMIS Anxiety Short Form Demographics and Health History Questionnaire Self-administered 24-hour Diet Recall Upon the completion of a baseline assessment, participants will be randomly assigned into one of two groups through a computer-generated code. Group 1: Instructor-led, one-on-one exercise group Group 2: Self-guided control with virtual fitness membership Group 1: For Instructor-led, one-on-one exercise group, participants will be asked to participate in 3 exercise sessions per week for 24 weeks. Each session will last from 15 minutes up to 40 minutes. Increasing by 5 to 10 minutes each week. The exercise program will focus on improving heart and lung fitness using a movement along with music. The program will be fit to individuals' abilities (e.g., use of arms only vs. truck movement together; slow vs. fast tempo music; use of wrist weight). The exercise will be prescribed at a moderate intensity level (working somewhat hard with increased heart rate and breathe rate), which will be monitored through a wearable heart rate monitor and custom designed online platform. All study equipment will be provided including tablet, wrist weights, and heart rate monitor. The exercise program will be delivered through a secured telehealth website (Telerehab) and a tablet that will be given from the study. Data collected by the platform includes exercise minutes and heart rate. The live sessions that participants attended with the instructor will be video-recorded and later uploaded to the telehealth platform. Upon the completion of the 24-week program, participants will be able to access exercise routines online to continue the exercise program for an additional 12 weeks. In addition, participants will receive access to live exercise classes that are offered by the National Center on Health, Physical Activity and Disability. Participants will be guided for further details during the orientation (after the physical tests of the baseline assessment). Group 2: For self-guided control group, participants will receive a tablet and 36-week virtual fitness membership that is offered via Lakeshore Foundation. The membership will give participants full access to live and recorded adapted classes, such as Seated Yoga, ABC's of Balance, and Total Body Conditioning. Participants will be given further details during the orientation (after the physical tests of the baseline assessment). 24-week & 36-week Follow-up Assessments: At the end of the 24- and 36-week, participants will be asked to complete the same set of physical tests and questionnaires you completed at the beginning of the study. Participants will also be asked to complete 2 additional questionnaires regarding the intervention quality, which are listed below. QUESTIONNAIRES: 12) Physical Activity Enjoyment Scale 13) System Usability Scale At the end of the 24-week, participants will be contacted by phone for a brief interview. This interview is to gain information about participation in the program, such as positive and negative experiences. This call will be recorded for data analysis purposes.

Official Title
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Examining the Effects of Live Telehealth Exercise Training on Cardiometabolic Outcomes in Wheelchair Users

Conditions
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Cardiometabolic Risk Factors in Adult Wheelchair Users

Intervention / Treatment
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* Other: Instructor-led, one-on-one exercise group
* Other: Self-guided control with virtual fitness membership


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full-time or part-time use of a wheelchair device (manual wheelchair, power wheelchair, electric scooter) self-reported as the primary means of mobility ≥ 2 cardiometabolic risk factor(s), no contraindication to exercise as informed by the Physical Activity Readiness Questionnaire (PAR-Q) (any contraindication will be reviewed by the participant's physician as a secondary approval method) age ≥18 years able to use arms to exercise obtaining < 90 minutes of moderate intensity exercise per week in the last month not enrolled in a structured exercise program in the past 6 months able to converse and read in English. Exclusion Criteria: medically unstable to perform home exercise as determined by their physician high level tetraplegia and unable to use arms to exercise no internet access determined via self-report and internet speed test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Instructor-led, one-on-one exercise group | Other: Instructor-led, one-on-one exercise group<br>* Participants will participate in 3 exercise sessions per week for 24 weeks. Each session will last 15 - 40 minutes. Increasing by 5 - 10 minutes each week. The program focuses on improving heart and lung fitness using movement with music. The program will be fit to individuals' abilities. The exercise is prescribed at a moderate intensity level, which is monitored through a wearable heart rate monitor and custom designed online platform (Telerehab). A tablet will be given by the study. Data collected include exercise minutes and heart rate. Live sessions that participants attended with the instructor will be video-recorded and later uploaded to the telehealth platform. Upon completion of the 24-week program, participants will be able to access exercise routines online for an additional 12 weeks. In addition, participants will receive access to live exercise classes offered by the National Center on Health, Physical Activity and Disability.<br>|
| Active Comparator: Group 2<br>Self-guided control with virtual fitness membership | Other: Self-guided control with virtual fitness membership<br>* Participants will receive a tablet and 36-week virtual fitness membership that is offered via Lakeshore Foundation. The membership will give participants full access to live and recorded adapted classes, such as Seated Yoga, ABC's of Balance, and Total Body Conditioning. Participants will be given further details during the orientation (after the physical tests of the baseline assessment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | Baseline | 
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | Baseline | 
| Cardiometabolic indicators - fasting insulin | Blood test SphygmomanometerSphygmomanometer | Baseline | 
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | Baseline | 
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | Baseline | 
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | 12 Weeks | 
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | 12 Weeks | 
| Cardiometabolic indicators - fasting insulin | Blood test Sphygmomanometer | 12 Weeks | 
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | 12 Weeks | 
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | 12 Weeks | 
| Cardiometabolic indicators - hsCRP | Blood test Sphygmomanometer | 24 Weeks | 
| Cardiometabolic indicators - HbA1C | Blood test Sphygmomanometer | 24 Weeks | 
| Cardiometabolic indicators - fasting insulin | Blood test Sphygmomanometer | 24 Weeks | 
| Cardiometabolic indicators - triglycerides | Blood test Sphygmomanometer | 24 Weeks | 
| Cardiometabolic indicators - cholesterol | Blood test Sphygmomanometer | 24 Weeks | 
| Body composition - Dexa | Dual energy X-ray absorptiometry | Baseline | 
| Body composition - Dexa | Dual energy X-ray absorptiometry | 12 Weeks | 
| Body composition - Dexa | Dual energy X-ray absorptiometry | 24 Weeks | 
| Body composition - Weight | Weight measurement | Baseline | 
| Body composition - Weight | Weight measurement | 12 Weeks | 
| Body composition - Weight | Weight measurement | 24 Weeks | 
| Body composition - Waist Circumference | Measurement of waist size | Baseline | 
| Body composition - Waist Circumference | Measurement of waist size | 12 Weeks | 
| Body composition - Waist Circumference | Measurement of waist size | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Baseline | 
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Open-circuit spirometry system (ParvoMedics TrueOne 2400) | 12 Weeks | 
| Cardiovascular capacity - Open-circuit spirometry system (ParvoMedics TrueOne 2400) | Open-circuit spirometry system (ParvoMedics TrueOne 2400) | 24 Weeks | 
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | Baseline | 
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | 12 Weeks | 
| Cardiovascular capacity - Polar heart rate monitor | Polar heart rate monitor | 24 Weeks | 
| Cardiovascular capacity - Borg RPE Scale | Borg RPE Scale | Baseline | 
| Cardiovascular capacity - Borg RPE Scale | Borg RPE Scale | 12 Weeks | 
| Cardiovascular capacity - Borg RPE Scale | Borg RPE Scale | 24 Weeks | 
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | Baseline | 
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | 12 Weeks | 
| Pulmonary function | Spirometry (forced expiratory volume over 1 second; forced vital capacity) | 24 Weeks | 
| Muscle strength | Biodex computerized dynamometer | Baseline | 
| Muscle strength | Biodex computerized dynamometer | 12 Weeks | 
| Muscle strength | Biodex computerized dynamometer | 24 Weeks | 
| Physical health | Complete NIH Promise online surveys | Baseline | 
| Physical health | Complete NIH Promise online surveys | 12 Weeks | 
| Physical health | Complete NIH Promise online surveys | 24 Weeks | 
| Physical health | Complete NIH Promise online surveys | 36 Weeks | 
| Physical activity | Complete LTPAQ-SCI online survey | Baseline | 
| Physical activity | Complete LTPAQ-SCI online survey | 12 Weeks | 
| Physical activity | Complete LTPAQ-SCI online survey | 24 Weeks | 
| Physical activity | Complete LTPAQ-SCI online survey | 36 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiometabolic Risk Factors, Adult Wheelchair Users