Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Energy expenditure |
energy expenditure will be assessed at two, randomly selected sessions for each participant. This will be done using a previously validated portable, open-circuit indirect calorimeter (Cosmed, Italy) which measures breath-by-breath ventilation, expired oxygen, and carbon dioxide. The flow turbine will be calibrated using a 3.0-L syringe. The lightweight (~1.5 kg) portable system will be attached by a harness around the waist and shoulders of the participant before each assessment. During exercise sessions, participants will breathe into a facemask that directs air into the unit housing the O2 and CO2 analyzers. Data will be retrieved for analysis via a serial port interface and software provided with the calorimeter and aggregated over 20-second epochs for the calculation of 1-min averages. |
Week 12 of the intervention - one time exploratory measure |
|
| Other |
Attendance |
Participant attendance for the functional fitness sessions will be recorded |
Observed each week of the 24-week intervention |
|
| Other |
Work Capacity |
Participants will complete work capacity testing during week 2, 12, and again at week 24. Work capacity (A1) will be assessed by the outcome measure of time to complete the benchmark exercise session - in minutes and seconds. Lower times indicate improved work capacity. |
Change in baseline work capacity (time; A1) at 12 weeks and 24 weeks of the intervention |
|
| Other |
Work Capacity |
Participants will complete work capacity testing during week 2, 12, and again at week 24. Work capacity (A2) will be assessed by number of rounds and repetitions completed during the exercise session in a given amount of time. Higher rounds and repetitions indicate improved work capacity. |
Change in baseline work capacity (reps; A2) at 12 weeks and 24 weeks of the intervention |
|
| Primary |
Weight |
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg. |
Change from Baseline weight at 6 months (post-intervention) |
|
| Secondary |
Body Composition |
Fat free and fat-mass Dual Energy X-ray Absorptiometry (DEXA) will be performed at the KU Edwards campus to determine the fat-free mass, fat mass, and body fat percentage (Prodigy Advance Plus, GE, Madison, WI) |
Change from Baseline body comp at 6 months (post-intervention) |
|
| Secondary |
Waist Circumference |
Waist circumference will be assessed with a calibrated tape. For those unable to stand, waist circumference will be measured in the seated position at the umbilicus. Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures. |
Change from Baseline waist circumference at 6 months (post-intervention) |
|
| Secondary |
Blood Pressure |
Blood pressure will be obtained with an automated sphygmomanometer (DinaMap ProCare 100, General Electric) using the NHANES blood pressure protocol and recommendations of the American Heart Association. |
Change from Baseline blood pressure (diastolic and systolic) at 6 months (post-intervention) |
|
| Secondary |
Glucose |
Fasting glucose will be assessed following finger prick blood draw with 8 hours prior of fasting |
Change from Baseline fasting glucose at 6 months (post-intervention) |
|
| Secondary |
Cholesterol |
HDL Cholestserol will be assessed following finger prick blood draw |
Change from Baseline HDL cholesterol at 6 months (post-intervention) |
|
| Secondary |
Triglycerides |
Triglycerides will be assessed following finger prick blood draw |
Change from Baseline triglycerides at 6 months (post-intervention) |
|
| Secondary |
Body Mass Index |
Weight will be measured in duplicate using a portable calibrated, digital scale to the nearest 0.1 kg. Height will be measured in meters, and body mass index (BMI) will be calculated with the following formula: kg/m2 |
Change from Baseline BMI at 6 months (post-intervention) |
|
| Secondary |
Perceived Quality of Life |
World Health Organization Quality of Life an internationally recognized and established short measure assessing quality of life. There are 26 items on this survey, with a minimum value of 26, and a maximum value of 130. The higher the score, the higher the perceived quality of life. |
Change from Baseline QOL at 6 months (post-intervention) |
|
| Secondary |
Perceived Life Satisfaction |
the Satisfaction with Life Questionnaire will be used as an additional assessment of well-being. There are five items on this survey, with a minimum score of 5 and a maximum score of 35, higher scores indicate higher satisfaction with life. |
Change from Baseline life satisfaction at 6 months (post-intervention) |
|
| Secondary |
Flexibility |
Back Scratch Test - 1 arm above the head, bent elbow, reach down across the back as far as possible. Simultaneously, the opposite arm bent at elbow and forearm is extended up along the back as far as possible to that the fingers of both hands meet or overlap. The distance of overlap or the distance between the tips of the middle fingers is measured in centimeters. |
Change from Baseline flexibility at 6 months (post-intervention) |
|
| Secondary |
Balance (Seated) |
Participants who are non-ambulatory participants will complete the Function in Sitting Test. Minimum score is 0 and maximum score is 56, where higher scores indicate better balance. |
Change from baseline balance at 6 months (post-intervention) |
|
| Secondary |
Balance (standing) |
Participants who are ambulatory will complete the Berg Balance Scale test. Minimum score is 0 and maximum score is 56, where higher scores indicate better balance. |
Change from baseline balance at 6 months (post-intervention) |
|
| Secondary |
Strength |
Grip Strength with dynameter. Participants will be seated with elbow flexed at 90 degrees, forearm in a neutral position and write between 0 and 30 degrees of flexion. participants will use their dominant hand and the 5 second squeeze will occur in duplicate, with 15 second rest in between and the score averaged to the nearest 0.1 kg. |
Change from baseline strength at 6 months (post-intervention) |
|
| Secondary |
Mobility |
participants who are ambulatory will complete the 6-minute walking test and the 10-meter walking speed test, both of which can be completed with the help of an assistive device as needed. Distance covered during the 6-minute walking test will be calculated with meters, and average walking speed will be calculated as miles per hour. Participants who are non-ambulatory will complete a 6-minute push test and the Timed Forward Wheeling (23-meters) test. Distance covered during the 6-minute push test will be converted to meters, and timed forward wheeling will assess average speed calculated as miles per hour. |
Change from baseline mobility at 6 months (post-intervention) |
|
| Secondary |
Sense of Community |
The Sense of Community Scale will be used to assess perceptions of community among the administration, social spaces, other members and competition. Minimum score is 18 and maximum score is 72, where higher scores indicate greater sense of community. |
Change from baseline sense of community at 6 months (post-intervention) |
|
| Secondary |
Shoulder Pain - manual wheelchair users only |
he Wheelchair User's Shoulder Pain Index will be used to assess self-report changes in shoulder pain during daily functional activities with a 10-point visual analog scale. Minimum score is 15 and maximum score is 150, where higher scores indicate greater pain. |
Change from baseline shoulder pain at 6 months (post-intervention) |
|
| Secondary |
Exercise self-efficacy |
28-item Self-Related Abilities for Health Practices Scale to assess self-efficacy scores regarding exercise, nutrition, health practices and psychological well-being. Minimum score is 0 and maximum score is 112, where higher scores indicate greater exercise self-efficacy. |
Change from baseline self-efficacy at 6 months (post-intervention) |
|
| Secondary |
Sleep |
Sleep Disturbance Short Form (PROMIS Health Organization, 8b) will be used to assess self-report sleep quality in the past 7 days. Minimum score is 8 and maximum score is 40, where lower scores indicate better sleep. |
Change from baseline sleep at 6 months (post-intervention) |
|
| Secondary |
Barriers to Health |
The 16-item Barriers to Health Adapted for People with Disabilities will assess participant self-report of perceived motivational and external barrier to exercise. Minimum score is 18 and maximum score is 72, where higher scores indicate greater perceived barriers to health promoting activities. |
Change from baseline perceived barriers at 6 months (post-intervention) |
|
| Secondary |
Psychological Need Satisfaction |
The Psychological Need Satisfaction in Exercise Questionnaire will be used to assess need satisfaction within the functional fitness environment. Include three subscale autonomy, competence, and relatedness. Minimum score is 18 and maximum score is 108, where higher scores indicate better need satisfaction. |
Change from baseline perceived need satisfaction at 6 months (post-intervention) |
|
| Secondary |
Self-determination |
Behavioral Regulation in Exercise Questionnaire will assess changes to perceived behavioral regulation (autonomous vs. external regulation) with in the functional fitness environment. 19 items with 5 subscales (external, introjected, identified, and intrinsic). Minimum score is 19 and maximum score is 95, where higher scores indicate more self-determined motives for exercise. |
Change from baseline perceived need self-determination at 6 months (post-intervention) |
|
| Secondary |
Perceived Functional Performance |
The Canadian Occupational Therapy Measure is a valid and reliable standardized assessment used to identify occupational performance problems experienced by a client. Performance areas report by the client as challenging or unable to do will be documented in a list. Then the client will rate the perceived importance of each problem area on the list. Only the most important performance areas (top five maximum) will be included in the COPM assessment. The client will then rate their current performance ability for each of these performance areas. The client's ratings of performance ability will be used to calculate the client's baseline average occupational performance ability. Baseline average performance scores are then used to determine if a client's occupational performance improvements occur over time. Range of scoring is 1-10, where higher scores indicate greater perceived performance. |
Change from baseline perceived performance in occupational activities at 6 months (post-intervention) |
|
| Secondary |
Perceived Functional Performance |
The Canadian Occupational Therapy Measure is a valid and reliable standardized assessment used to identify occupational performance problems experienced by a client. Performance areas report by the client as challenging or unable to do will be documented in a list. Then the client will rate the perceived importance of each problem area on the list. Only the most important performance areas (top five maximum) will be included in the COPM assessment. The client will then rate their current satisfaction of their ability for each of these performance areas. The client's ratings satisfaction will be used to calculate the client's baseline average occupational satisfaction of their ability. Baseline average satisfaction scores are then used to determine if a client's occupational performance improvements occur over time. Range of scoring is 1-10, where higher scores indicate greater perceived satisfaction. |
Change from baseline perceived satisfaction in performing occupational activities at 6 months (post-intervention) |
|
