Spinal Cord InjuriesNCT04007445
Exercise for People with Spinal Cord Injury
A study testing Formally Directed Group (Exercise Group) in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to examine the impact of a transitional exercise intervention implemented in the community for people with SCI on psychological well-being, social factors, and physiological health. 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?
- Formally Directed Group (Exercise Group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants will be non-exercising adults with SCI who have participated in less than 60 minutes of moderate-intensity exercise per week in the last month. Participants must meet the following inclusion criteria: diagnosis of an SCI; are 18 years or older; have written physician approval to participate in the study; have the ability to use upper, lower, or both sets of extremities to exercise; and have the ability to understand English.
Who cannot join
- Participants will be excluded if they are medically unstable, have a cognitive impairment that does not allow them to provide consent, are currently or have previously been participants in the PQHWC or community-based exercise program, or have been enrolled in a structured exercise program over the past six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Exercise Training in a Community-based Setting for People with Spinal Cord Injuries
The purpose of the study is to examine the impact of a transitional exercise intervention implemented in the community for people with SCI on psychological well-being, social factors, and physiological health.
Read the detailed description
People with spinal cord injuries (SCI) are at a greater risk for major health conditions and poorer health outcomes than the population without disabilities. For people with SCI, physical activity is critical for both physiological and psychological well-being. Currently a gap exists; prior research indicates that exercise programs conducted in a controlled clinical setting have positive effects on the physical and psychosocial fitness of people with SCI, but rarely are these programs available in accessible community-based exercise facilities. With this study, the investigators aim to evaluate the improvements of the exercise group - EG (formally-directed) in both psychological and physiological well-being as compared to the control group - CG (self-directed). The investigators also aim to identify the perspectives of the participants on the recruitment and enrollment process, the assessment methods, and the intervention protocol. The long-term goal of this research is to improve outcomes of people with SCI once they leave rehabilitation by identifying strategies to promote health and support exercise in the community. This study will implement rigorous research procedures to examine a transitional exercise intervention in the community for people with SCI. This study will serve as the initial step toward that goal by pilot testing an exercise intervention to help with the transition from supported exercise programs experienced during rehabilitation to the community. The investigators will recruit 40 adults with SCI to participate in this study; the EG will participate in a transitional 12-week exercise intervention at Paraquad Health and Wellness Center (PQHWC). The CG will participate in a one-hour education session, learning about the National Council on Health, Physical Activity and Disability (NCHPAD), and then they will maintain their typical physical activity on their own for a 12-week period. This project will measure the potential psychosocial and physiological health benefits of participating in a transitional community-based exercise intervention. The investigators will then use the findings to define how exercise in the community can support health outcomes and improve therapeutic interventions to promote health of people with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- Formally Directed Group (Exercise Group), Self-Directed Group (Control Group)
- Keywords
- spinal cord injury, exercise, occupational therapy
- 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.
Formally Directed Group (Exercise Group)Behavioural
This group will receive a 12-week exercise intervention that will educate and support the person's ability to exercise. Working with a trainer, the participant will attend a 12-week (3 x week) exercise program that has been personalized to their goals. Each session will include warm-up, stretching, cardiovascular exercises, strength exercises, and cool-down. Each session will be 1-2 hours in duration. The participants may wear accelerometers and heart rate monitors to help determine the level of intensity of the exercises, as they should be performing at least 150 minutes of moderate to vigorous exercise each week. By the end of the 12-week program, the goal is for participants to guide their own exercise regimens.
Self-Directed Group (Control Group)Other
This group will receive a 1-hour education session during which they will learn about the National Council on Health, Physical Activity and Disability (NCHPAD) website, an information and resource center on health promotion for people with disabilities. During the session participants will be given an overview of the website and asked to find three resources they find of interest. Their strength and fitness will also be assessed by completing a 1-rep max test. The participants will then be asked to maintain their regular physical activity for the next 12 weeks and complete a weekly physical activity log to track their exercise participation. A staff member will phone each person every week for the 12-week period and have the participant report his or her physical activity during the week.
| Study group | Role | What they receive |
|---|---|---|
| Formally Directed Group (Exercise Group) | Active comparator | A group performing a 12 - week guided exercise program at an accessible Community Health and Wellness Center Receives: Behavioral: Formally Directed Group (Exercise Group) |
| Self-Directed Group (Control Group) | Placebo comparator | A group receiving educational information about physical activity and exercise at home and then self-directing a 12 - week exercise program on their own. Receives: Other: Self-Directed Group (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS - Change in Fatigue (Short Form 8a)
The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely impacts one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
PROMIS - Change in Emotional Distress - Depression (Short Form 8a)
The Depression item banks assess self-reported negative mood (sadness, guilt), views of self(self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as changed positive affect and engagement (loss of interest, meaning, and purpose). The depression short forms are not disease specific and assess depression over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
PROMIS - Change in Pain Intensity (Short Form 3a)
The Pain Intensity instruments assess how much a person hurts. The pain intensity short forms are not disease specific and assess pain intensity over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
PROMIS - Change in Pain Interference (Short Form 8a)
The Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The pain interference short forms are not disease specific and assess pain interference over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
PROMIS - Change in Sleep Disturbance (Short Form 8a)
The Sleep disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The sleep disturbance short forms are not disease specific and assess sleep disturbances over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
PROMIS - Change in Emotional Support
The Emotional support item banks assess perceived feelings of being cared for and valued as a person; 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.
The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
Measured: Baseline, post intervention and 3 month follow-up
Secondary outcomes (2)
The Exercise Self-Efficacy Scale (ESES)
The ESES is a 10-item, SCI-specific scale developed to measure perceived exercise self-efficacy for various types of physical activities. The scale requires individuals to self-report their confidence in performing physical activities and exercise. One dichotomous item asks whether the individual has exercised at home and/or in a gym in the past 12 months. Individuals respond to the 10 items using a four-point Likert scale (1: not at all true, 4: always true); the total score is then derived by summing the scores for the individual items; scores range from 10 to 40. Higher scores indicate greater perceived self-efficacy. The dichotomous item is used to estimate the participant's average exercise activity.
Measured: Baseline, post intervention, 3 month follow-up
RM 4-FM: Motivation for Physical Activity and Exercise/Working Out - Questionnaire
The RM 4-FM assesses a person's motivation for exercise or working out to determine the impact of intrinsic and extrinsic factors.
Measured: Baseline, post intervention, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Apr 2017
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Model description
- The proposed project utilizes a mixed methods approach. An experimental strategy using a randomized control trial (single-blinded) will be used to assess the efficacy of an established transitional, community-based exercise intervention on people with SCI. Qualitative methods will be used to gather information related to optimizing implementation of a community-based exercise intervention. This project will be conducted in conjunction with Paraquad, a local independent living center. Forty participants will be randomized into an Exercise Group (EG) or Control Group (CG) by the statistician who will not be involved in either conducting outcome assessments or implementation of the intervention. This design will assist in reducing variability and maximizing the effect size for powering subsequent larger randomized control trials.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Kerri Morgan, Washington University School of Medicine
- Investigators
- Kerri A Morgan, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007445
- Sponsor's protocol ID
- 201701143
- Status last verified
- May 2020
- First submitted
- 1 Jul 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97. doi: 10.1016/j.apmr.2005.09.014.
PubMed 16442971Miller LC, Gottlieb M, Morgan KA, Gray DB. Interviews with employed people with mobility impairments and limitations: environmental supports impacting work acquisition and satisfaction. Work. 2014;48(3):361-72. doi: 10.3233/WOR-131784.
PubMed 24284677Kroll T, Kehn M, Ho PS, Groah S. The SCI Exercise Self-Efficacy Scale (ESES): development and psychometric properties. Int J Behav Nutr Phys Act. 2007 Aug 30;4:34. doi: 10.1186/1479-5868-4-34.
PubMed 17760999American College of Sports Medicine. (2010). ACSM's Guidelines for Exercise Testing and Prescription. 8th ed. Philadelphia: Lippincott Williams & Wilkins.
Kroll T, Barbour R, Harris J. Using focus groups in disability research. Qual Health Res. 2007 May;17(5):690-8. doi: 10.1177/1049732307301488.
PubMed 17478650Krueger RA, Casey MA. (2009). Focus Groups: A Practical Guide For Applied Research 4th ed. Thousand Oaks, CA: Sage.
White GW, Suchowierska M, Campbell M. Developing and systematically implementing participatory action research. Arch Phys Med Rehabil. 2004 Apr;85(4 Suppl 2):S3-12. doi: 10.1016/j.apmr.2003.08.109.
PubMed 15083417Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
PubMed 23499781Ginis 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 20434610Jelleyman C, Yates T, O'Donovan G, Gray LJ, King JA, Khunti K, Davies MJ. The effects of high-intensity interval training on glucose regulation and insulin resistance: a meta-analysis. Obes Rev. 2015 Nov;16(11):942-61. doi: 10.1111/obr.12317.
PubMed 26481101Cowan RE, Callahan MK, Nash MS. The 6-min push test is reliable and predicts low fitness in spinal cord injury. Med Sci Sports Exerc. 2012 Oct;44(10):1993-2000. doi: 10.1249/MSS.0b013e31825cb3b6.
PubMed 22617394
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in a Community-based Setting for People with Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT04007445
- Acronym / sponsor ID
- 201701143
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, exercise, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the impact of a transitional exercise intervention implemented in the community for people with SCI on psychological well-being, social factors, and physiological health.
Detailed description
People with spinal cord injuries (SCI) are at a greater risk for major health conditions and poorer health outcomes than the population without disabilities. For people with SCI, physical activity is critical for both physiological and psychological well-being. Currently a gap exists; prior research indicates that exercise programs conducted in a controlled clinical setting have positive effects on the physical and psychosocial fitness of people with SCI, but rarely are these programs available in accessible community-based exercise facilities. With this study, the investigators aim to evaluate the improvements of the exercise group - EG (formally-directed) in both psychological and physiological well-being as compared to the control group - CG (self-directed). The investigators also aim to identify the perspectives of the participants on the recruitment and enrollment process, the assessment methods, and the intervention protocol. The long-term goal of this research is to improve outcomes of people with SCI once they leave rehabilitation by identifying strategies to promote health and support exercise in the community. This study will implement rigorous research procedures to examine a transitional exercise intervention in the community for people with SCI. This study will serve as the initial step toward that goal by pilot testing an exercise intervention to help with the transition from supported exercise programs experienced during rehabilitation to the community. The investigators will recruit 40 adults with SCI to participate in this study; the EG will participate in a transitional 12-week exercise intervention at Paraquad Health and Wellness Center (PQHWC). The CG will participate in a one-hour education session, learning about the National Council on Health, Physical Activity and Disability (NCHPAD), and then they will maintain their typical physical activity on their own for a 12-week period. This project will measure the potential psychosocial and physiological health benefits of participating in a transitional community-based exercise intervention. The investigators will then use the findings to define how exercise in the community can support health outcomes and improve therapeutic interventions to promote health of people with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed project utilizes a mixed methods approach. An experimental strategy using a randomized control trial (single-blinded) will be used to assess the efficacy of an established transitional, community-based exercise intervention on people with SCI. Qualitative methods will be used to gather information related to optimizing implementation of a community-based exercise intervention. This project will be conducted in conjunction with Paraquad, a local independent living center. Forty participants will be randomized into an Exercise Group (EG) or Control Group (CG) by the statistician who will not be involved in either conducting outcome assessments or implementation of the intervention. This design will assist in reducing variability and maximizing the effect size for powering subsequent larger randomized control trials.
| Arm | Type | Receives |
|---|---|---|
| Formally Directed Group (Exercise Group) | Active comparator | Behavioral: Formally Directed Group (Exercise Group)A group performing a 12 - week guided exercise program at an accessible Community Health and Wellness Center |
| Self-Directed Group (Control Group) | Placebo comparator | Other: Self-Directed Group (Control Group)A group receiving educational information about physical activity and exercise at home and then self-directing 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 (1 listed)
- Participants will be non-exercising adults with SCI who have participated in less than 60 minutes of moderate-intensity exercise per week in the last month. Participants must meet the following inclusion criteria: diagnosis of an SCI; are 18 years or older; have written physician approval to participate in the study; have the ability to use upper, lower, or both sets of extremities to exercise; and have the ability to understand English.
Key exclusion criteria (1 listed)
- Participants will be excluded if they are medically unstable, have a cognitive impairment that does not allow them to provide consent, are currently or have previously been participants in the PQHWC or community-based exercise program, or have been enrolled in a structured exercise program over the past six months.
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 |
|---|---|---|
| Formally Directed Group (Exercise Group)This group will receive a 12-week exercise intervention that will educate and support the person's ability to exercise. Working with a trainer, the participant will attend a 12-week (3 x week) exercise program that has been personalized to their goals. Each session will include warm-up, stretching, cardiovascular exercises, strength exercises, and cool-down. Each session will be 1-2 hours in duration. The participants may wear accelerometers and heart rate monitors to help determine the level of intensity of the exercises, as they should be performing at least 150 minutes of moderate to vigorous exercise each week. By the end of the 12-week program, the goal is for participants to guide their own exercise regimens. | Behavioural | Formally Directed Group (Exercise Group) |
| Self-Directed Group (Control Group)This group will receive a 1-hour education session during which they will learn about the National Council on Health, Physical Activity and Disability (NCHPAD) website, an information and resource center on health promotion for people with disabilities. During the session participants will be given an overview of the website and asked to find three resources they find of interest. Their strength and fitness will also be assessed by completing a 1-rep max test. The participants will then be asked to maintain their regular physical activity for the next 12 weeks and complete a weekly physical activity log to track their exercise participation. A staff member will phone each person every week for the 12-week period and have the participant report his or her physical activity during the week. | Other | Self-Directed Group (Control Group) |
Primary outcome
PROMIS - Change in Fatigue (Short Form 8a)
Time frame: Baseline, post intervention and 3 month follow-up
The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely impacts one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Emotional Distress - Depression (Short Form 8a)
Time frame: Baseline, post intervention and 3 month follow-up
The Depression item banks assess self-reported negative mood (sadness, guilt), views of self(self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as changed positive affect and engagement (loss of interest, meaning, and purpose). The depression short forms are not disease specific and assess depression over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Pain Intensity (Short Form 3a)
Time frame: Baseline, post intervention and 3 month follow-up
The Pain Intensity instruments assess how much a person hurts. The pain intensity short forms are not disease specific and assess pain intensity over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Pain Interference (Short Form 8a)
Time frame: Baseline, post intervention and 3 month follow-up
The Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The pain interference short forms are not disease specific and assess pain interference over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Sleep Disturbance (Short Form 8a)
Time frame: Baseline, post intervention and 3 month follow-up
The Sleep disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The sleep disturbance short forms are not disease specific and assess sleep disturbances over the past seven 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
PROMIS - Change in Emotional Support
Time frame: Baseline, post intervention and 3 month follow-up
The Emotional support item banks assess perceived feelings of being cared for and valued as a person; 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)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.
2 secondary outcomes
The Exercise Self-Efficacy Scale (ESES)
Time frame: Baseline, post intervention, 3 month follow-up
RM 4-FM: Motivation for Physical Activity and Exercise/Working Out - Questionnaire
Time frame: Baseline, post intervention, 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 16442971Gray DB, Hollingsworth HH, Stark SL, Morgan KA. Participation survey/mobility: psychometric properties of a measure of participation for people with mobility impairments and limitations. Arch Phys Med Rehabil. 2006 Feb;87(2):189-97. doi: 10.1016/j.apmr.2005.09.014.
- Background: PubMed 24284677Miller LC, Gottlieb M, Morgan KA, Gray DB. Interviews with employed people with mobility impairments and limitations: environmental supports impacting work acquisition and satisfaction. Work. 2014;48(3):361-72. doi: 10.3233/WOR-131784.
- Background: PubMed 17760999Kroll T, Kehn M, Ho PS, Groah S. The SCI Exercise Self-Efficacy Scale (ESES): development and psychometric properties. Int J Behav Nutr Phys Act. 2007 Aug 30;4:34. doi: 10.1186/1479-5868-4-34.
- BackgroundAmerican College of Sports Medicine. (2010). ACSM's Guidelines for Exercise Testing and Prescription. 8th ed. Philadelphia: Lippincott Williams & Wilkins.
- Background: PubMed 17478650Kroll T, Barbour R, Harris J. Using focus groups in disability research. Qual Health Res. 2007 May;17(5):690-8. doi: 10.1177/1049732307301488.
- BackgroundKrueger RA, Casey MA. (2009). Focus Groups: A Practical Guide For Applied Research 4th ed. Thousand Oaks, CA: Sage.
- Background: PubMed 15083417White GW, Suchowierska M, Campbell M. Developing and systematically implementing participatory action research. Arch Phys Med Rehabil. 2004 Apr;85(4 Suppl 2):S3-12. doi: 10.1016/j.apmr.2003.08.109.
- Background: PubMed 23499781Askari S, Kirby RL, Parker K, Thompson K, O'Neill J. Wheelchair propulsion test: development and measurement properties of a new test for manual wheelchair users. Arch Phys Med Rehabil. 2013 Sep;94(9):1690-8. doi: 10.1016/j.apmr.2013.03.002. Epub 2013 Mar 14.
- Background: PubMed 20434610Ginis 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.
- Background: PubMed 26481101Jelleyman C, Yates T, O'Donovan G, Gray LJ, King JA, Khunti K, Davies MJ. The effects of high-intensity interval training on glucose regulation and insulin resistance: a meta-analysis. Obes Rev. 2015 Nov;16(11):942-61. doi: 10.1111/obr.12317.
- Background: PubMed 22617394Cowan RE, Callahan MK, Nash MS. The 6-min push test is reliable and predicts low fitness in spinal cord injury. Med Sci Sports Exerc. 2012 Oct;44(10):1993-2000. doi: 10.1249/MSS.0b013e31825cb3b6.
- Individual participant dataSharing planned: No
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At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
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 Formally Directed Group (Exercise Group) 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 1 inclusion and 1 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 28 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PROMIS - Change in Fatigue (Short Form 8a) (time frame: Baseline, post intervention and 3 month follow-up). The study lists 6 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 NCT04007445, which also lists 11 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 28 Mar 2025.