Spinal Cord InjuriesNCT03411720
Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
A study testing FES Row Training in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. 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?
- FES Row Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 31 May 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
- Adults (>18 years of age)
- Be in good health (asymptomatic for acute treatable illness) and medically cleared to exercise
- Own an iPhone or Android smartphone with the capacity to download and run the research platform (able to log into to the relevant app store, install the app on their own phone, and run the app).
- Be able to understand, communicate with and be understood by research personnel or Interpreters
- Be interested in participating and provide informed consent
- Have a SCI with motor or sensory deficits and use a wheelchair as primary means of mobility
- Have an injury level only as high as C4 to allow sufficient arm function for rowing
Who cannot join
- Participants will not have previously completed FESRT
- Acute illness
- Musculoskeletal injuries that have not healed completely
- Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
- uncontrolled dysrhythmias
Show all 10Show fewer
- Recent history of congestive heart failure that has not been evaluated and effectively treated
- Severe stenotic or regurgitant valvular disease
- Hypertrophic cardiomyopathy
- Unhealed pressure ulcer Stage 2 or higher at relevant contact sites during exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Network
Cambridge, Massachusetts, 02139
About this study
Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI. Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. This work will use approaches to overcome the barriers to intense exercise. The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES Row Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES Row TrainingOther
Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
| Study group | Role | What they receive |
|---|---|---|
| FES-row-training | Experimental | Subjects will perform 4 months of FES-row-raining Receives: Other: FES Row Training |
| Wait-list time control | Other | Subjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training Receives: Other: FES Row Training |
| Arms-only-row-training | Active comparator | Subjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training Receives: Other: FES Row Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
Measured: Each week during the 4 months
Pain Severity
Difference between groups in pain severity, rated on a 0-10 scale ("0 being no pain and 10 being pain so severe you couldn't stand it"); Within-individual Correlation of exercise intensity with pain.
Measured: Each week during the 4 months
Pain Interference
Difference between groups in pain interference in daily life activities ("0. Not at all 1. A little bit 2. Moderately 3. Quite a bit 4. Extremely"); Within-individual Correlation of exercise intensity with pain.
Measured: Each week during the 4 months
Anxiety
Difference between groups in anxiety (Spinal Cord Injury Quality of Life Anxiety Short Form); Within-individual Correlation of exercise intensity with anxiety. Minimum score is 9, Maximum score is 45. Higher scores indicate higher anxiety.
Measured: Each week during the 4 months
Satisfaction with Social Participation
Difference between groups in satisfaction with social roles and activities (Spinal Cord Injury Quality of Life Satisfaction with Social Roles and Activities Short Form); Within-individual Correlation of exercise intensity with satisfaction with social participation. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
Measured: Each week during the 4 months
Ability to participate in social roles
Difference between groups in ability to participate in social roles and activities. Spinal Cord Injury Quality of Life Ability to Participate in Social Roles and Activities Short Form. Within-individual Correlation of exercise intensity with ability to participate in social roles. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
Measured: Each week during the 4 months
Secondary outcomes (4)
Health Complications
Difference between groups in frequency of secondary health complications; Within-individual Correlation of exercise intensity with secondary health complications.
Measured: Each week during the 4 months
Community Mobility
Difference between groups in community mobility (Distance traveled each week); Within-individual Correlation of exercise intensity with community mobility.
Measured: Each week during the 4 months
Social Connectivity: Frequency
Difference between groups in social connectivity (Frequency of phone calls and text messages); Within-individual Correlation of exercise intensity with frequency of social connectivity.
Measured: Each week during the 4 months
Social Connectivity: Reciprocity
Difference between groups in social connectivity (Reciprocity of phone calls and text messages); Within-individual Correlation of exercise intensity with reciprocity of social connectivity.
Measured: Each week during the 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start28 Feb 2018
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, J. Andrew Taylor, Spaulding Rehabilitation Hospital
- Investigators
- J. Andrew Taylor, Principal investigator, Spaulding Rehabilitation Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411720
- Sponsor's protocol ID
- 2017D006049
- Status last verified
- Jun 2020
- First submitted
- 5 Jan 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function
- ClinicalTrials.gov ID
- NCT03411720
- Acronym / sponsor ID
- 2017D006049
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Jan 2018 (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.
Persons with spinal cord injury (SCI) are confronted with a multitude of psychological and physiological changes post-injury leading to seemingly insurmountable barriers to participating in daily life. After injury persons with SCI engage in fewer social interactions, spend more time sedentary, and are less likely to leave the home. This leads to restricted social participation that, in turn, contributes to greater psychological problems and negatively impacts the lives of adults with SCI. Intense, structured exercise has substantial potential benefits for improving psychosocial wellbeing among persons with SCI, but accessible exercise options are few and cannot achieve high intensities of whole-body exercise. This work will use approaches to overcome the barriers to intense exercise. The investigators will use hybrid functional electrical stimulation row training (FESRT) to allow for a more intense exercise stimulus, potentially having a greater impact on psychosocial wellbeing. There is initial evidence that persons with mobility impairments who are highly physically active demonstrate better psychosocial wellbeing compared with those who have low levels of physical activity. A limitation to understanding the influence of exercise on psychosocial wellbeing is the lack of robust and time-dependent measures. The investigators will use a smartphone-based research application to measure psychosocial well-being, thus decreasing self-report bias and capturing in-the-moment behavioral and self-report data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FES-row-training | Experimental | Other: FES Row TrainingSubjects will perform 4 months of FES-row-raining |
| Wait-list time control | Other | Other: FES Row TrainingSubjects will wait 4 months before performing being allowed to engage in 4 months of FES-row-training |
| Arms-only-row-training | Active comparator | Other: FES Row TrainingSubjects will perform 4 months of arms-only row training before being allowed to engage in 4 months of FES-row-training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (>18 years of age)
Key exclusion criteria (10 listed)
- Participants will not have previously completed FESRT
- Acute illness
- Musculoskeletal injuries that have not healed completely
- Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, -Unstable angina
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
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 |
|---|---|---|
| FES Row TrainingHybrid FES Row Training using voluntary upper body and electrically-stimulated lower body | Other | Arms-only-row-training, FES-row-training, Wait-list time control |
Primary outcome
Depression
Time frame: Each week during the 4 months
Difference between groups in depression symptom severity (Patient Health Questionnaire-9); Within-individual Correlation of exercise intensity with depression
Pain Severity
Time frame: Each week during the 4 months
Difference between groups in pain severity, rated on a 0-10 scale ("0 being no pain and 10 being pain so severe you couldn't stand it"); Within-individual Correlation of exercise intensity with pain.
Pain Interference
Time frame: Each week during the 4 months
Difference between groups in pain interference in daily life activities ("0. Not at all 1. A little bit 2. Moderately 3. Quite a bit 4. Extremely"); Within-individual Correlation of exercise intensity with pain.
Anxiety
Time frame: Each week during the 4 months
Difference between groups in anxiety (Spinal Cord Injury Quality of Life Anxiety Short Form); Within-individual Correlation of exercise intensity with anxiety. Minimum score is 9, Maximum score is 45. Higher scores indicate higher anxiety.
Satisfaction with Social Participation
Time frame: Each week during the 4 months
Difference between groups in satisfaction with social roles and activities (Spinal Cord Injury Quality of Life Satisfaction with Social Roles and Activities Short Form); Within-individual Correlation of exercise intensity with satisfaction with social participation. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
Ability to participate in social roles
Time frame: Each week during the 4 months
Difference between groups in ability to participate in social roles and activities. Spinal Cord Injury Quality of Life Ability to Participate in Social Roles and Activities Short Form. Within-individual Correlation of exercise intensity with ability to participate in social roles. The Minimum score is 20 and the maximum score is 50. Higher values indicate greater satisfaction with social participation.
4 secondary outcomes
Health Complications
Time frame: Each week during the 4 months
Community Mobility
Time frame: Each week during the 4 months
Social Connectivity: Frequency
Time frame: Each week during the 4 months
Social Connectivity: Reciprocity
Time frame: Each week during the 4 months
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 22 Jun 2020.
- Individual participant dataSharing planned: No
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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.
J. Andrew Taylor principal investigator
Spaulding Rehabilitation Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Row Training in people with Spinal Cord Injuries, run by Spaulding Rehabilitation Hospital 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 7 inclusion and 10 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 22 Jun 2020. 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. 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?
Depression (time frame: Each week during the 4 months). 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?
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 22 Jun 2020.