An interventional study of Community-based Exercise Intervention group (CBE) and Exercise Education Control group (EEG) in Spinal Cord Injuries, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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:
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.
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This study's enrollment of 49 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
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Exclusion Criteria:
A group performing a 12-week guided exercise program at an accessible community health and wellness center
Behavioral: Community-based Exercise Intervention group (CBE)
A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own.
Behavioral: Exercise Education Control group (EEG)
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.
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Started | 27 | 22 |
| Completed | 15 | 17 |
| Not completed | 12 | 5 |
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.
| ml/kg/min | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 14.69 ± 1.22 | 14.36 ± 1.28 |
| Post | 15.61 ± 1.95 | 13.74 ± 1.09 |
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.
| percentage of body fat | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 39.800 ± .1000 | — |
| Post | 38.750 ± 2.2500 | — |
Blood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
| percentage of HbA1c levels | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 4.9 | 5.0 |
| Post | 4.9 ± .4000 | 5.0 |
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.
| mg/dL | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 172 ± 39 | 188 |
| Post | 170. ± 50 | 212 |
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.
| inch-pound | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 287.83 ± 29.87 | 277.0 ± 28.17 |
| Post | 351.37 ± 31.89 | 315.47 ± 29.44 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 48.09 ± 1.49 | 49.31 ± 2.53 |
| Post | 46.71 ± 1.66 | 50.43 ± 1.73 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 47.21 ± 2.36 | 51.44 ± 2.92 |
| Post | 45.31 ± 1.75 | 51.69 ± 2.48 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 46.23 ± 3.37 | 45.08 ± 2.10 |
| Post | 45.01 ± 3.23 | 45.43 ± 2.52 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 52.24 ± 2.6 | 52.06 ± 2.51 |
| Post | 52.64 ± 2.64 | 51.96 ± 2.17 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 48.71 ± 2.36 | 50.48 ± 2.63 |
| Post | 48.87 ± 3.49 | 51.31 ± 2.77 |
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.
| T-score | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) |
|---|---|---|
| Pre | 55.77 ± 2.47 | 49.66 ± 1.94 |
| Post | 55.01 ± 2.39 | 49.58 ± 1.63 |
Collected over We collected adverse event data for approximately 6 months on each individual and tracked adverse events on all participants through the entirety of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Community-based Exercise Intervention Group (CBEI) | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Exercise Education Control Group (EEG) | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) | Total |
|---|---|---|---|
| Mean | 38.04 ± 10.847 | 40.77 ± 15.991 | 39.27 ± 13.323 |
| Sex: Female, Male(Participants) | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 20 | 17 | 37 |
| Race (NIH/OMB)(Participants) | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 11 | 27 |
| White | 7 | 8 | 15 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Community-based Exercise Intervention Group (CBEI) | Exercise Education Control Group (EEG) | Total |
|---|---|---|---|
| United States | 27 | 22 | 49 |
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Washington University School of Medicine