Spinal Cord InjuriesNCT03941600

Feasibility of Exercise and Spinal Cord Injury

A study testing Community-based Exercise Intervention group (CBE) in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injuries
What is being tested?: Community-based Exercise Intervention group (CBE)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2019to 30 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Be able to follow multi-step instructions
Independently provide informed consent
Willing to participate in three assessments and 36 intervention sessions

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63108

Other trials in United States

About this study

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

Read the 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:

Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group.
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.

Conditions: Spinal Cord Injuries
Being tested: Community-based Exercise Intervention group (CBE), Exercise Education Control group (EEG)
Keywords: occupational therapy, exercise
Medical subject headings: Spinal Cord Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community-based Exercise Intervention group (CBE)Behavioural
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.
Exercise Education Control group (EEG)Behavioural
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.

Study groups in NCT03941600
Study group	Role	What they receive
Community-based Exercise Intervention group (CBEI)	Active comparator	A group performing a 12-week guided exercise program at an accessible community health and wellness center Receives: Behavioral: Community-based Exercise Intervention group (CBE)
Exercise Education Control group (EEG)	Placebo comparator	A group receiving educational information about physical activity and exercise at home and then self-direction a 12-week exercise program on their own. Receives: Behavioral: Exercise Education Control group (EEG)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Up to 4 weeks post interventions

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Up to 4 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201930 Aug 2021

First posted8 May 2019
Study start10 Apr 2019
Primary completion30 Aug 2021
Study completion30 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (34)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03941600
Sponsor's protocol ID: 201809174
Other IDs: K12HD055931
Status last verified: Jan 2023
First submitted: 18 Jan 2019
Last updated: 17 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

National Spinal Cord Injury Statistical Center. (2016). 2016 Annual Statistical Report - Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.
Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.
PubMed 15077662
West CR, Alyahya A, Laher I, Krassioukov A. Peripheral vascular function in spinal cord injury: a systematic review. Spinal Cord. 2013 Jan;51(1):10-9. doi: 10.1038/sc.2012.136. Epub 2012 Nov 27.
PubMed 23184028
Froehlich-Grobe K, Jones D, Businelle MS, Kendzor DE, Balasubramanian BA. Impact of disability and chronic conditions on health. Disabil Health J. 2016 Oct;9(4):600-8. doi: 10.1016/j.dhjo.2016.04.007. Epub 2016 May 3.
PubMed 27216441
Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.
PubMed 28089898
Hicks AL, Martin Ginis KA, Pelletier CA, Ditor DS, Foulon B, Wolfe DL. The effects of exercise training on physical capacity, strength, body composition and functional performance among adults with spinal cord injury: a systematic review. Spinal Cord. 2011 Nov;49(11):1103-27. doi: 10.1038/sc.2011.62. Epub 2011 Jun 7.
PubMed 21647163
Carroll DD, Courtney-Long EA, Stevens AC, Sloan ML, Lullo C, Visser SN, Fox MH, Armour BS, Campbell VA, Brown DR, Dorn JM; Centers for Disease Control and Prevention (CDC). Vital signs: disability and physical activity--United States, 2009-2012. MMWR Morb Mortal Wkly Rep. 2014 May 9;63(18):407-13.
PubMed 24807240
Ginis KA, Arbour-Nicitopoulos KP, Latimer AE, Buchholz AC, Bray SR, Craven BC, Hayes KC, Hicks AL, McColl MA, Potter PJ, Smith K, Wolfe DL. Leisure time physical activity in a population-based sample of people with spinal cord injury part II: activity types, intensities, and durations. Arch Phys Med Rehabil. 2010 May;91(5):729-33. doi: 10.1016/j.apmr.2009.12.028.
PubMed 20434610
Sullivan KJ. President's perspectives. Healthcare Reform: a call to action for our patients. J Neurol Phys Ther. 2009 Sep;33(3):171-2. doi: 10.1097/NPT.0b013e3181b65372. No abstract available.
PubMed 19809396
McCormick ZL, Lynch M, Liem B, Jacobs G, Hwang P, Hornby TG, Rydberg L, Roth E. Feasibility for developing cardiovascular exercise recommendations for persons with motor-complete paraplegia based on manual wheelchair propulsion; A protocol and preliminary data. J Spinal Cord Med. 2016;39(1):45-9. doi: 10.1179/2045772314Y.0000000292. Epub 2015 Jan 13.
PubMed 25582138
Kaye, H. S., Kang, T., & LaPlante, M. P. (2000). Mobility device use in the United States. (No. 14). Washington, DC: U.S. Department of Education, National Institute on Disability and Rehabilitation Research.
Zwinkels M, Verschuren O, Janssen TW, Ketelaar M, Takken T; Sport-2-Stay-Fit study group; Sport-2-Stay-Fit study group. Exercise training programs to improve hand rim wheelchair propulsion capacity: a systematic review. Clin Rehabil. 2014 Sep;28(9):847-61. doi: 10.1177/0269215514525181. Epub 2014 Mar 10.
PubMed 24615862
American College of Sports Medicine. (2014). ACSM's Guidelines for Exercise Testing and Prescription (9th ed.). Philadelphia: Lippincott Williams & Wilkins.
Totosy de Zepetnek JO, Pelletier CA, Hicks AL, MacDonald MJ. Following the Physical Activity Guidelines for Adults With Spinal Cord Injury for 16 Weeks Does Not Improve Vascular Health: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Sep;96(9):1566-75. doi: 10.1016/j.apmr.2015.05.019. Epub 2015 Jun 10.
PubMed 26070976
Gebel K, Ding D, Chey T, Stamatakis E, Brown WJ, Bauman AE. Effect of Moderate to Vigorous Physical Activity on All-Cause Mortality in Middle-aged and Older Australians. JAMA Intern Med. 2015 Jun;175(6):970-7. doi: 10.1001/jamainternmed.2015.0541.
PubMed 25844882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of a Community-based Exercise Intervention for Persons With Spinal Cord Injury
ClinicalTrials.gov ID: NCT03941600
Acronym / sponsor ID: 201809174
Conditions: Spinal Cord Injuries
Keywords: occupational therapy, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 10 Apr 2019 (actual)
Primary completion: 30 Aug 2021 (actual)
Study completion: 30 Aug 2021 (actual)
First posted: 8 May 2019 (actual)
Results: Posted 17 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The project research aims are to:

Estimate improvements in physical function, cardio-metabolic health, and psychological well-being of participants enrolled in a CBEI compared to an education-only group.
Identify barriers, facilitators, and reasons for positive determinants for PwSCI to exercise in a community-based setting.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Community-based Exercise Intervention group (CBEI)	Active comparator	Behavioral: Community-based Exercise Intervention group (CBE)A group performing a 12-week guided exercise program at an accessible community health and wellness center
Exercise Education Control group (EEG)	Placebo comparator	Behavioral: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Community-based Exercise Intervention group (CBEI)
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.	Behavioural	Exercise Education Control group (EEG)

Primary outcome

VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

7 secondary outcomes

Upper Extremity Strength - Upper Body Strength Change
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Fatigue Short Form 8a
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Emotional Distress - Depression - Short Form 8a
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Pain Intensity - Short Form 3a
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Pain Interference - Short Form 8a
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Sleep Disturbance - Short Form 8a
Time frame: Baseline and Up to 4 weeks post intervention
PROMIS - Emotional Support
Time frame: Baseline and Up to 4 weeks post intervention

Results and safety

Results posted to the registry on 17 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Community-based Exercise Intervention Group (CBEI)	27	15
Exercise Education Control Group (EEG)	22	17

Primary outcome: VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change)

Time frame: Baseline and Up to 4 weeks post intervention. Mean (Standard Error). Unit: ml/kg/min

Measure	Community-based Exercise Intervention Group (CBEI) n = 9	Exercise Education Control Group (EEG) n = 13
Pre	14.69 (1.22)	14.36 (1.28)
Post	15.61 (1.95)	13.74 (1.09)

Population analysed: 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.

Primary outcome: DEXA - Body Composition Overall Body Fat % Change

Time frame: Baseline and Up to 4 weeks post intervention. Mean (Standard Error). Unit: percentage of body fat

Measure	Community-based Exercise Intervention Group (CBEI) n = 2	Exercise Education Control Group (EEG) n = 0
Pre	39.800 (.1000)	–
Post	38.750 (2.2500)	–

Population analysed: 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.

Primary outcome: Metabolic Blood Chemistries - HbA1c Level Change

Time frame: Baseline and Up to 4 weeks post intervention. Mean (Standard Error). Unit: percentage of HbA1c levels

Measure	Community-based Exercise Intervention Group (CBEI) n = 2	Exercise Education Control Group (EEG) n = 1
Pre	4.9	5.0
Post	4.9 (.4000)	5.0

Population analysed: 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.

Primary outcome: Metabolic Blood Chemistries - Cholesterol Change

Time frame: Baseline and Up to 4 weeks post interventions. Mean (Standard Error). Unit: mg/dL

Measure	Community-based Exercise Intervention Group (CBEI) n = 2	Exercise Education Control Group (EEG) n = 1
Pre	172 (39)	188
Post	170. (50)	212

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Community-based Exercise Intervention Group (CBEI)	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Exercise Education Control Group (EEG)	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundNational Spinal Cord Injury Statistical Center. (2016). 2016 Annual Statistical Report - Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.
Background: PubMed 15077662Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.
Background: PubMed 23184028West CR, Alyahya A, Laher I, Krassioukov A. Peripheral vascular function in spinal cord injury: a systematic review. Spinal Cord. 2013 Jan;51(1):10-9. doi: 10.1038/sc.2012.136. Epub 2012 Nov 27.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kerri A Morgan, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community-based Exercise Intervention group (CBE) in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VO2 Peak - Cardiorespiratory Fitness Change (Peak Oxygen Consumption Change) (time frame: Baseline and Up to 4 weeks post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941600, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.