Spinal Cord Injuries
Conditions
Keywords
occupational therapy, exercise
Brief summary
The purpose of the study is to examine the impact of a community-based exercise intervention (CBEI) for persons with spinal cord injury (PwSCI) on physiological and psychological well-being and identify barriers and facilitators to implementation.
Detailed description
People with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than the population without spinal cord injury. For PwSCI, habitual exercise is critical for both physiological and psychological well-being. Prior research indicates that exercise programs conducted in a controlled setting have positive effects on the physical and psychosocial fitness of PwSCI, but the efficacy and feasibility of these programs are not well understood in community-based settings. The proposed project aims to examine potential health benefits in response to the intervention and identify the barriers and facilitators to successful implementation of a CBEI in PwSCI. The long-term goal of this research is to improve health outcomes of PwSCI by identifying strategies to promote health and support exercise in the community. The project research aims are to: 1. Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group. 2. Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting. A single-blind pilot RCT will be conducted. Forty individuals with SCI will be recruited. Each participant will be randomized into either a 12-week CBEI (n=20) or an education control group (n=20). Participants' cardiorespiratory fitness, body composition, metabolic blood chemistries and strength will be assessed pre- (T1) and post- (T2) intervention.
Interventions
The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale.
The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used.
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of SCI * 18 years or older * Have written physician approval to participate in the study * Ability to use upper extremities to exercise * Participate in \< 60 minutes of moderate-intensity exercise per week in the last month * Understand English at a sixth-grade level or higher * Be able to follow multi-step instructions * Independently provide informed consent * Willing to participate in three assessments and 36 intervention sessions
Exclusion criteria
* Enrollment in a structured exercise program in the past six months. * Have had cardiovascular complications within the past year * Currently receive medical treatment for an acute upper extremity injury * Have a Stage IV pressure injury * Have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) | Baseline and Up to 4 weeks post intervention | VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes. |
| DEXA - Body Composition Overall Body Fat % Change | Baseline and Up to 4 weeks post intervention | Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure. |
| Metabolic Blood Chemistries - HbA1c Level Change | Baseline and Up to 4 weeks post intervention | Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw. |
| Metabolic Blood Chemistries - Cholesterol Change | Baseline and Up to 4 weeks post interventions | Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL. Participants will fast 8-10 hours prior to blood draw. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Pain Interference - Short Form 8a | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference - assesses self-reported consequences of pain on relevant aspects of one's life over the past 7 days, this includes how pain hinders engagement with social, cognitive, emotional, physical and recreational activities. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from not at all (1) to very much (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain interference, a t-score of 60-70 indicates moderate pain interference and a t-score of 70 or above indicates severe pain interference. |
| Upper Extremity Strength - Upper Body Strength Change | Baseline and Up to 4 weeks post intervention | Strength will be measured via isotonic 1RM testing unilaterally on four upper-extremity exercises (chest press, back row, rickshaw, biceps flexion) using a BTE™ PrimusRS (BTE™, Hanover, MD). Data was organized into one single strength variable by summing the 4 left side upper extremity exercises together, then summing the 4 right side upper extremity exercises together, and finally taking those 2 totals (from left side and right side) and summing them into one strength variable. A higher number indicates more strength. The BTE™ PrimusRS uses an inch-pound (the torque of one pound of force applied to one inch of distance from the pivot) as it's unit of measurement. |
| PROMIS - Emotional Support | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support - assesses perceived feelings of being cared for and valued as a person and having confident relationships. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from never (1) to always (5). The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 40-60 indicates an average amount of emotional support, a t-score of 60-70 indicates high levels of emotional support, and a t-score of 70 or above indicates very high levels of emotional support. |
| PROMIS - Sleep Disturbance - Short Form 8a | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep - assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from very poor (1) to very good (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild sleep disturbance, a t-score of 60-70 indicates moderate sleep disturbance and a t-score of 70 or above indicates severe sleep disturbance. |
| PROMIS - Fatigue Short Form 8a | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue - assesses a range of self-reported fatigue symptoms over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from not at all (1) to very much (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild fatigue, a t-score of 60-70 indicates moderate fatigue and a t-score of 70 or above indicates severe fatigue. |
| PROMIS - Emotional Distress - Depression - Short Form 8a | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Emotional distress - Depression - assesses self-reported negative mood, views of self, social cognition, as well as decreased positive affect and engagement over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from never (1) to always (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild depression, a t-score of 60-70 indicates moderate depression and a t-score of 70 or above indicates severe depression. |
| PROMIS - Pain Intensity - Short Form 3a | Baseline and Up to 4 weeks post intervention | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity - assesses how much a person hurts over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from had no pain (1) to very severe (5) with a raw score between 3 and 15. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain intensity, a t-score of 60-70 indicates moderate pain intensity and a t-score of 70 or above indicates severe pain intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Community-based Exercise Intervention Group (CBEI) A group performing a 12-week guided exercise program at an accessible community health and wellness center
Community-based Exercise Intervention group (CBE): The CBEI group will receive 36 (60-90 minute) one-on-one, formally directed exercise sessions by trained staff over 12 weeks. By the end the goal is to have the participants guiding their own regimens. Personalized sessions will be created for each participant based on their fitness goal(s) and preferences. Each session will include vitals, pain assessment, warm-up, stretching, cardiovascular, and strength exercises and cool-down. The participants will be monitored to ensure they are achieving at least 30 minutes of moderate-to-vigorous exercise 3 times a week. Activity monitors will also be worn to capture intensity data. At the end of each session, participants will describe their likes and dislike as well as what they gained and what they suggest for improvement. At the end of each session, the trainer will rate the participant's perceived participation during the session (1-6) using the Pittsburgh Rehabilitation Participation Scale. | 27 |
| Exercise Education Control Group (EEG) A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Exercise Education Control group (EEG): The EEG group will complete an intervention that consists of a one-on-one, hour-long educational session orienting participants to an online resource center, the National Center on Health, Physical Activity, and Disability (NCHPAD). NCHPAD promotes health and well-being for PwD through resources such as adapted exercise videos, information on accessible fitness equipment, personalized exercise videos tailored to PwD, and an individualized 14-week exercise program. Participants will be given an overview of NCHPAD and asked to identify resources of interest on the website. Each participant will be asked to use resources on NCHPAD to engage in physical activity for 12 weeks. Each participant will receive a weekly phone call to inquire about their physical activity, exercises engaged in, RPE during exercise, and whether any resources were used. | 22 |
| Total | 49 |
Baseline characteristics
| Characteristic | Community-based Exercise Intervention Group (CBEI) | Total | Exercise Education Control Group (EEG) |
|---|---|---|---|
| Age, Continuous | 38.04 years STANDARD_DEVIATION 10.847 | 39.27 years STANDARD_DEVIATION 13.323 | 40.77 years STANDARD_DEVIATION 15.991 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 27 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 27 participants | 49 participants | 22 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 20 Participants | 37 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 22 |
| other Total, other adverse events | 0 / 27 | 0 / 22 |
| serious Total, serious adverse events | 0 / 27 | 0 / 22 |
Outcome results
DEXA - Body Composition Overall Body Fat % Change
Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure.
Time frame: Baseline and Up to 4 weeks post intervention
Population: Only 2 participants (both from the CBEI group) were able to complete this outcome measure due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | DEXA - Body Composition Overall Body Fat % Change | Pre | 39.800 percentage of body fat | Standard Error 0.1 |
| Community-based Exercise Intervention Group (CBEI) | DEXA - Body Composition Overall Body Fat % Change | Post | 38.750 percentage of body fat | Standard Error 2.25 |
Metabolic Blood Chemistries - Cholesterol Change
Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL. Participants will fast 8-10 hours prior to blood draw.
Time frame: Baseline and Up to 4 weeks post interventions
Population: Only 3 participants (2 CBEI and 1 EEG) were able to complete this outcome measure due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | Metabolic Blood Chemistries - Cholesterol Change | Pre | 172 mg/dL | Standard Error 39 |
| Community-based Exercise Intervention Group (CBEI) | Metabolic Blood Chemistries - Cholesterol Change | Post | 170. mg/dL | Standard Error 50 |
| Exercise Education Control Group (EEG) | Metabolic Blood Chemistries - Cholesterol Change | Pre | 188 mg/dL | — |
| Exercise Education Control Group (EEG) | Metabolic Blood Chemistries - Cholesterol Change | Post | 212 mg/dL | — |
Metabolic Blood Chemistries - HbA1c Level Change
Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
Time frame: Baseline and Up to 4 weeks post intervention
Population: This data was only collected on 2 participants (1 CBEI group and 1 EEG group) at the pre-assessment period and 3 participants (2 CBEI group and 1 EEG group) at post assessment. We were not able to complete this outcome measure on any further participants due to the COVID-19 pandemic. Our research project was considered non-essential and therefore the services to conduct these assessments were shut down and not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | Metabolic Blood Chemistries - HbA1c Level Change | Pre | 4.9 percentage of HbA1c levels | — |
| Community-based Exercise Intervention Group (CBEI) | Metabolic Blood Chemistries - HbA1c Level Change | Post | 4.9 percentage of HbA1c levels | Standard Error 0.4 |
| Exercise Education Control Group (EEG) | Metabolic Blood Chemistries - HbA1c Level Change | Pre | 5.0 percentage of HbA1c levels | — |
| Exercise Education Control Group (EEG) | Metabolic Blood Chemistries - HbA1c Level Change | Post | 5.0 percentage of HbA1c levels | — |
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy UT) while the participant performs a graded-exercise test on an arm crank ergometer (SCIFIT PRO2, Life Fitness, Tulsa, OK). The protocol involves a 3-minute warm-up followed by a standard ramp protocol which is typically completed in 8-12 minutes.
Time frame: Baseline and Up to 4 weeks post intervention
Population: Only valid data was analyzed. Data deemed valid when the following criteria was met, (before/within 1 minute of cooldown, RER =/\> 1.1, RPE reported as =/\>15. A participant's PRE/POST scores both had to be valid to be included in analysis. CBEI group = 6 participants excluded, 3 did not have any valid VO2 test, 3 only had 1 valid VO2 test. EEG group = 1 did not have any valid VO2 test, 2 only had 1 valid VO2 test, 1 participant was unable to physically complete the test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) | Pre | 14.69 ml/kg/min | Standard Error 1.22 |
| Community-based Exercise Intervention Group (CBEI) | VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) | Post | 15.61 ml/kg/min | Standard Error 1.95 |
| Exercise Education Control Group (EEG) | VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) | Pre | 14.36 ml/kg/min | Standard Error 1.28 |
| Exercise Education Control Group (EEG) | VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) | Post | 13.74 ml/kg/min | Standard Error 1.09 |
PROMIS - Emotional Distress - Depression - Short Form 8a
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional distress - Depression - assesses self-reported negative mood, views of self, social cognition, as well as decreased positive affect and engagement over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from never (1) to always (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild depression, a t-score of 60-70 indicates moderate depression and a t-score of 70 or above indicates severe depression.
Time frame: Baseline and Up to 4 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Emotional Distress - Depression - Short Form 8a | Pre | 47.21 T-score | Standard Error 2.36 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Emotional Distress - Depression - Short Form 8a | Post | 45.31 T-score | Standard Error 1.75 |
| Exercise Education Control Group (EEG) | PROMIS - Emotional Distress - Depression - Short Form 8a | Pre | 51.44 T-score | Standard Error 2.92 |
| Exercise Education Control Group (EEG) | PROMIS - Emotional Distress - Depression - Short Form 8a | Post | 51.69 T-score | Standard Error 2.48 |
PROMIS - Emotional Support
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support - assesses perceived feelings of being cared for and valued as a person and having confident relationships. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from never (1) to always (5). The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 40-60 indicates an average amount of emotional support, a t-score of 60-70 indicates high levels of emotional support, and a t-score of 70 or above indicates very high levels of emotional support.
Time frame: Baseline and Up to 4 weeks post intervention
Population: One participant within the Community-based Exercise Intervention group (CBEI) post data was missing, therefore only 14 were analyzed instead of 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Emotional Support | Pre | 55.77 T-score | Standard Error 2.47 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Emotional Support | Post | 55.01 T-score | Standard Error 2.39 |
| Exercise Education Control Group (EEG) | PROMIS - Emotional Support | Pre | 49.66 T-score | Standard Error 1.94 |
| Exercise Education Control Group (EEG) | PROMIS - Emotional Support | Post | 49.58 T-score | Standard Error 1.63 |
PROMIS - Fatigue Short Form 8a
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue - assesses a range of self-reported fatigue symptoms over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from not at all (1) to very much (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild fatigue, a t-score of 60-70 indicates moderate fatigue and a t-score of 70 or above indicates severe fatigue.
Time frame: Baseline and Up to 4 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Fatigue Short Form 8a | Pre | 48.09 T-score | Standard Error 1.49 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Fatigue Short Form 8a | Post | 46.71 T-score | Standard Error 1.66 |
| Exercise Education Control Group (EEG) | PROMIS - Fatigue Short Form 8a | Pre | 49.31 T-score | Standard Error 2.53 |
| Exercise Education Control Group (EEG) | PROMIS - Fatigue Short Form 8a | Post | 50.43 T-score | Standard Error 1.73 |
PROMIS - Pain Intensity - Short Form 3a
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity - assesses how much a person hurts over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from had no pain (1) to very severe (5) with a raw score between 3 and 15. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain intensity, a t-score of 60-70 indicates moderate pain intensity and a t-score of 70 or above indicates severe pain intensity.
Time frame: Baseline and Up to 4 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Pain Intensity - Short Form 3a | Pre | 46.23 T-score | Standard Error 3.37 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Pain Intensity - Short Form 3a | Post | 45.01 T-score | Standard Error 3.23 |
| Exercise Education Control Group (EEG) | PROMIS - Pain Intensity - Short Form 3a | Pre | 45.08 T-score | Standard Error 2.1 |
| Exercise Education Control Group (EEG) | PROMIS - Pain Intensity - Short Form 3a | Post | 45.43 T-score | Standard Error 2.52 |
PROMIS - Pain Interference - Short Form 8a
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference - assesses self-reported consequences of pain on relevant aspects of one's life over the past 7 days, this includes how pain hinders engagement with social, cognitive, emotional, physical and recreational activities. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from not at all (1) to very much (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild pain interference, a t-score of 60-70 indicates moderate pain interference and a t-score of 70 or above indicates severe pain interference.
Time frame: Baseline and Up to 4 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Pain Interference - Short Form 8a | Post | 52.64 T-score | Standard Error 2.64 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Pain Interference - Short Form 8a | Pre | 52.24 T-score | Standard Error 2.6 |
| Exercise Education Control Group (EEG) | PROMIS - Pain Interference - Short Form 8a | Pre | 52.06 T-score | Standard Error 2.51 |
| Exercise Education Control Group (EEG) | PROMIS - Pain Interference - Short Form 8a | Post | 51.96 T-score | Standard Error 2.17 |
PROMIS - Sleep Disturbance - Short Form 8a
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep - assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep over the past 7 days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from very poor (1) to very good (5) with a raw score between 8 and 40. The t-score was automatically calculated using REDCap auto-score. A t-score of 50 indicates the mean score for the general population with a standard deviation of 10. A higher score reflects more of the domain being assessed. A t-score of 55-60 indicates mild sleep disturbance, a t-score of 60-70 indicates moderate sleep disturbance and a t-score of 70 or above indicates severe sleep disturbance.
Time frame: Baseline and Up to 4 weeks post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Sleep Disturbance - Short Form 8a | Pre | 48.71 T-score | Standard Error 2.36 |
| Community-based Exercise Intervention Group (CBEI) | PROMIS - Sleep Disturbance - Short Form 8a | Post | 48.87 T-score | Standard Error 3.49 |
| Exercise Education Control Group (EEG) | PROMIS - Sleep Disturbance - Short Form 8a | Pre | 50.48 T-score | Standard Error 2.63 |
| Exercise Education Control Group (EEG) | PROMIS - Sleep Disturbance - Short Form 8a | Post | 51.31 T-score | Standard Error 2.77 |
Upper Extremity Strength - Upper Body Strength Change
Strength will be measured via isotonic 1RM testing unilaterally on four upper-extremity exercises (chest press, back row, rickshaw, biceps flexion) using a BTE™ PrimusRS (BTE™, Hanover, MD). Data was organized into one single strength variable by summing the 4 left side upper extremity exercises together, then summing the 4 right side upper extremity exercises together, and finally taking those 2 totals (from left side and right side) and summing them into one strength variable. A higher number indicates more strength. The BTE™ PrimusRS uses an inch-pound (the torque of one pound of force applied to one inch of distance from the pivot) as it's unit of measurement.
Time frame: Baseline and Up to 4 weeks post intervention
Population: 1 participant from the Excercise Education Control group (EEG) was unable to do the PRE upper extremity strength measure at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | Upper Extremity Strength - Upper Body Strength Change | Pre | 287.83 inch-pound | Standard Error 29.87 |
| Community-based Exercise Intervention Group (CBEI) | Upper Extremity Strength - Upper Body Strength Change | Post | 351.37 inch-pound | Standard Error 31.89 |
| Exercise Education Control Group (EEG) | Upper Extremity Strength - Upper Body Strength Change | Pre | 277.0 inch-pound | Standard Error 28.17 |
| Exercise Education Control Group (EEG) | Upper Extremity Strength - Upper Body Strength Change | Post | 315.47 inch-pound | Standard Error 29.44 |