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Feasibility of Exercise and Spinal Cord Injury

Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03941600
Enrollment
49
Registered
2019-05-08
Start date
2019-04-10
Completion date
2021-08-30
Last updated
2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

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

BEHAVIORALCommunity-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.

BEHAVIORALExercise 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)Baseline and Up to 4 weeks post interventionVO2 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 % ChangeBaseline and Up to 4 weeks post interventionParticipants 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 ChangeBaseline and Up to 4 weeks post interventionBlood draws will be completed to measure HbA1c levels in %. Participants will fast 8-10 hours prior to blood draw.
Metabolic Blood Chemistries - Cholesterol ChangeBaseline and Up to 4 weeks post interventionsBlood 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

MeasureTime frameDescription
PROMIS - Pain Interference - Short Form 8aBaseline and Up to 4 weeks post interventionPatient 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 ChangeBaseline and Up to 4 weeks post interventionStrength 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 SupportBaseline and Up to 4 weeks post interventionPatient 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 8aBaseline and Up to 4 weeks post interventionPatient 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 8aBaseline and Up to 4 weeks post interventionPatient 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 8aBaseline and Up to 4 weeks post interventionPatient 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 3aBaseline and Up to 4 weeks post interventionPatient 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

ArmCount
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
Total49

Baseline characteristics

CharacteristicCommunity-based Exercise Intervention Group (CBEI)TotalExercise Education Control Group (EEG)
Age, Continuous38.04 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 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
16 Participants27 Participants11 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
7 Participants15 Participants8 Participants
Region of Enrollment
United States
27 participants49 participants22 participants
Sex: Female, Male
Female
7 Participants12 Participants5 Participants
Sex: Female, Male
Male
20 Participants37 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 22
other
Total, other adverse events
0 / 270 / 22
serious
Total, serious adverse events
0 / 270 / 22

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)DEXA - Body Composition Overall Body Fat % ChangePre39.800 percentage of body fatStandard Error 0.1
Community-based Exercise Intervention Group (CBEI)DEXA - Body Composition Overall Body Fat % ChangePost38.750 percentage of body fatStandard Error 2.25
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)Metabolic Blood Chemistries - Cholesterol ChangePre172 mg/dLStandard Error 39
Community-based Exercise Intervention Group (CBEI)Metabolic Blood Chemistries - Cholesterol ChangePost170. mg/dLStandard Error 50
Exercise Education Control Group (EEG)Metabolic Blood Chemistries - Cholesterol ChangePre188 mg/dL
Exercise Education Control Group (EEG)Metabolic Blood Chemistries - Cholesterol ChangePost212 mg/dL
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)Metabolic Blood Chemistries - HbA1c Level ChangePre4.9 percentage of HbA1c levels
Community-based Exercise Intervention Group (CBEI)Metabolic Blood Chemistries - HbA1c Level ChangePost4.9 percentage of HbA1c levelsStandard Error 0.4
Exercise Education Control Group (EEG)Metabolic Blood Chemistries - HbA1c Level ChangePre5.0 percentage of HbA1c levels
Exercise Education Control Group (EEG)Metabolic Blood Chemistries - HbA1c Level ChangePost5.0 percentage of HbA1c levels
Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)Pre14.69 ml/kg/minStandard Error 1.22
Community-based Exercise Intervention Group (CBEI)VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)Post15.61 ml/kg/minStandard Error 1.95
Exercise Education Control Group (EEG)VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)Pre14.36 ml/kg/minStandard Error 1.28
Exercise Education Control Group (EEG)VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)Post13.74 ml/kg/minStandard Error 1.09
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Emotional Distress - Depression - Short Form 8aPre47.21 T-scoreStandard Error 2.36
Community-based Exercise Intervention Group (CBEI)PROMIS - Emotional Distress - Depression - Short Form 8aPost45.31 T-scoreStandard Error 1.75
Exercise Education Control Group (EEG)PROMIS - Emotional Distress - Depression - Short Form 8aPre51.44 T-scoreStandard Error 2.92
Exercise Education Control Group (EEG)PROMIS - Emotional Distress - Depression - Short Form 8aPost51.69 T-scoreStandard Error 2.48
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Emotional SupportPre55.77 T-scoreStandard Error 2.47
Community-based Exercise Intervention Group (CBEI)PROMIS - Emotional SupportPost55.01 T-scoreStandard Error 2.39
Exercise Education Control Group (EEG)PROMIS - Emotional SupportPre49.66 T-scoreStandard Error 1.94
Exercise Education Control Group (EEG)PROMIS - Emotional SupportPost49.58 T-scoreStandard Error 1.63
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Fatigue Short Form 8aPre48.09 T-scoreStandard Error 1.49
Community-based Exercise Intervention Group (CBEI)PROMIS - Fatigue Short Form 8aPost46.71 T-scoreStandard Error 1.66
Exercise Education Control Group (EEG)PROMIS - Fatigue Short Form 8aPre49.31 T-scoreStandard Error 2.53
Exercise Education Control Group (EEG)PROMIS - Fatigue Short Form 8aPost50.43 T-scoreStandard Error 1.73
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Pain Intensity - Short Form 3aPre46.23 T-scoreStandard Error 3.37
Community-based Exercise Intervention Group (CBEI)PROMIS - Pain Intensity - Short Form 3aPost45.01 T-scoreStandard Error 3.23
Exercise Education Control Group (EEG)PROMIS - Pain Intensity - Short Form 3aPre45.08 T-scoreStandard Error 2.1
Exercise Education Control Group (EEG)PROMIS - Pain Intensity - Short Form 3aPost45.43 T-scoreStandard Error 2.52
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Pain Interference - Short Form 8aPost52.64 T-scoreStandard Error 2.64
Community-based Exercise Intervention Group (CBEI)PROMIS - Pain Interference - Short Form 8aPre52.24 T-scoreStandard Error 2.6
Exercise Education Control Group (EEG)PROMIS - Pain Interference - Short Form 8aPre52.06 T-scoreStandard Error 2.51
Exercise Education Control Group (EEG)PROMIS - Pain Interference - Short Form 8aPost51.96 T-scoreStandard Error 2.17
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)PROMIS - Sleep Disturbance - Short Form 8aPre48.71 T-scoreStandard Error 2.36
Community-based Exercise Intervention Group (CBEI)PROMIS - Sleep Disturbance - Short Form 8aPost48.87 T-scoreStandard Error 3.49
Exercise Education Control Group (EEG)PROMIS - Sleep Disturbance - Short Form 8aPre50.48 T-scoreStandard Error 2.63
Exercise Education Control Group (EEG)PROMIS - Sleep Disturbance - Short Form 8aPost51.31 T-scoreStandard Error 2.77
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Community-based Exercise Intervention Group (CBEI)Upper Extremity Strength - Upper Body Strength ChangePre287.83 inch-poundStandard Error 29.87
Community-based Exercise Intervention Group (CBEI)Upper Extremity Strength - Upper Body Strength ChangePost351.37 inch-poundStandard Error 31.89
Exercise Education Control Group (EEG)Upper Extremity Strength - Upper Body Strength ChangePre277.0 inch-poundStandard Error 28.17
Exercise Education Control Group (EEG)Upper Extremity Strength - Upper Body Strength ChangePost315.47 inch-poundStandard Error 29.44

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026