Spinal Cord InjuryNCT02139436
Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
A study testing FES-row-training and Arms-only-row training in people with Spinal Cord Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- FES-row-training and Arms-only-row training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 1 Mar 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Spinal cord injured outpatients aged 18-40
- medically stable
- body mass index 18.5-30.0
- 3-12 months post SCI
- ASIA scale A, B or C at neurological level C5-T12
- able to follow directions
- leg muscles responsive to FES
Who cannot join
- hypertension
- significant arrhythmias
- coronary artery disease
- diabetes
- renal disease
- cancer
Show all 12Show fewer
- epilepsy
- current use of cardioactive medications
- current grade 2 or greater pressure ulcers at relevant contact sites
- other neurological disease
- peripheral nerve compressions or rotator cuff tears that limit ability to row
- history of bleeding disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
About this study
Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.
Read the detailed description
We will enroll approximately 60 individuals within three to six months post SCI to obtain data on 50 individuals. One-half of the subjects (N=25) will be randomized to immediately enroll in 6 months of FES-RT. One third (N=18) will be randomized to a wait-list to provide time control data from baseline to 6 months. A wait-list control group is routine in exercise studies because most volunteers are interested in participating in an exercise program. Hence, time controls are difficult to capture since many of those randomized to receive no exercise either drop from the study entirely, or end up pursuing some form of exercise on their own. Therefore, a vehicle for enrollment of a time control group that is acceptable to most volunteers is a wait-list. Therefore, a six month time control will provide data on expected declines and then subjects will be randomized to six months exercise.
Training Protocols for Each Study Group
- FES-RT GROUP Subjects will begin with short intervals of FES-RT interspersed with rest intervals and/or arms-only rowing intervals depending on fitness level and the response to the FES. A maximum FES-rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. The goal is for each volunteer to achieve an exercise intensity of 75-85% maintained for a continuous 30 minutes performed three times each week. A maximum FES-rowing test will be performed at the end of the six months of FES-RT to determine increases in fitness.
- ARMS-ONLY-RT GROUP Training sessions will be 3 times per week for 26 weeks. To parallel the FES-RT, the initial training sessions will also consist of 6 sets of arms-only rowing for five minutes at 60% of VO2peak with a work-to-rest ratio of 2:1 and progress over the six months to an exercise intensity of 75-85% maintained for 30 minutes performed three times each week. A maximum arms-only rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. A maximum arms-only rowing test will be performed at the end of the six months of training to determine increases in fitness.
- WAIT-LIST GROUP
The wait list group will not participate in any training for 6 months. A maximum arms-only rowing test will be performed immediately after enrollment, after initial familiarization with arms-only-RT equipment (usually 2-3 sessions) and will be repeated after 3 and 6 months
- Conditions
- Spinal Cord Injury
- Being tested
- FES-row-training, Arms-only-row training, Time Control
- 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
Arms-only-row trainingOther
Time ControlOther
| Study group | Role | What they receive |
|---|---|---|
| FES-row-training | Experimental | Subjects will perform 6 months of FES-row-training. Receives: Other: FES-row-training |
| Wait-list time control | Other | Subjects perform 6 months of their standard of care Receives: Other: Time Control |
| Arms-only-row-training | Active comparator | Subjects will perform 6 months of arms-only row training Receives: Other: Arms-only-row training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Exercise Capacity at 6 Months
Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.
Measured: Baseline and 6 months
Change From Baseline in Visceral Adiposity at 6 Months
We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.
Measured: Baseline, 6 months
Change From Baseline in Myocardial Structure at 6 Months.
Echocardiography was performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function.
Measured: Baseline and 6 months
Change From Baseline in Insulin Sensitivity at 6 Months.
Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance.
Measured: Baseline and 6 months
Change From Baseline in Blood Lipids at 6 Months
Blood will be taken via standard venipuncture to measure: total cholesterol.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startDec 2013
- Primary completion1 Mar 2020
- Study completion1 Mar 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 (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Model description
- Three intervention groups (Control, AO-Row, and FES-RT) run in parallel
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, J. Andrew Taylor, Spaulding Rehabilitation Hospital
- Investigators
- J. Andrew Taylor, Ph.D., Principal investigator, Spaulding Rehabilitation Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139436
- Sponsor's protocol ID
- 1R01HL117037
- Other IDs
- 1R01HL117037
- Status last verified
- Feb 2022
- First submitted
- 12 May 2014
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yates BA, Brown R, Picard G, Taylor JA. Improved pulmonary function is associated with reduced inflammation after hybrid whole-body exercise training in persons with spinal cord injury. Exp Physiol. 2023 Mar;108(3):353-360. doi: 10.1113/EP090785. Epub 2023 Jan 9.
PubMed 36622954Ely MR, Schleifer GD, Singh TK, Baggish AL, Taylor JA. Exercise Training Does Not Attenuate Cardiac Atrophy or Loss of Function in Individuals With Acute Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2023 Jun;104(6):909-917. doi: 10.1016/j.apmr.2022.12.001. Epub 2022 Dec 23.
PubMed 36572202Solinsky R, Schleifer GD, Draghici AE, Hamner JW, Taylor JA. Methodologic implications for rehabilitation research: Differences in heart rate variability introduced by respiration. PM R. 2022 Dec;14(12):1483-1489. doi: 10.1002/pmrj.12770. Epub 2022 Mar 12.
PubMed 35077032Solinsky R, Draghici A, Hamner JW, Goldstein R, Taylor JA. High-intensity, whole-body exercise improves blood pressure control in individuals with spinal cord injury: A prospective randomized controlled trial. PLoS One. 2021 Mar 4;16(3):e0247576. doi: 10.1371/journal.pone.0247576. eCollection 2021.
PubMed 33661958Ely MR, Singh TK, Baggish AL, Taylor JA. Reductions in Cardiac Structure and Function 24 Months After Spinal Cord Injury: A Cross-Sectional Study. Arch Phys Med Rehabil. 2021 Aug;102(8):1490-1498. doi: 10.1016/j.apmr.2021.01.070. Epub 2021 Feb 5.
PubMed 33556347
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
- ClinicalTrials.gov ID
- NCT02139436
- Acronym / sponsor ID
- 1R01HL117037
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2013
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.
Detailed description
We will enroll approximately 60 individuals within three to six months post SCI to obtain data on 50 individuals. One-half of the subjects (N=25) will be randomized to immediately enroll in 6 months of FES-RT. One third (N=18) will be randomized to a wait-list to provide time control data from baseline to 6 months. A wait-list control group is routine in exercise studies because most volunteers are interested in participating in an exercise program. Hence, time controls are difficult to capture since many of those randomized to receive no exercise either drop from the study entirely, or end up pursuing some form of exercise on their own. Therefore, a vehicle for enrollment of a time control group that is acceptable to most volunteers is a wait-list. Therefore, a six month time control will provide data on expected declines and then subjects will be randomized to six months exercise.
Training Protocols for Each Study Group
- FES-RT GROUP Subjects will begin with short intervals of FES-RT interspersed with rest intervals and/or arms-only rowing intervals depending on fitness level and the response to the FES. A maximum FES-rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. The goal is for each volunteer to achieve an exercise intensity of 75-85% maintained for a continuous 30 minutes performed three times each week. A maximum FES-rowing test will be performed at the end of the six months of FES-RT to determine increases in fitness.
- ARMS-ONLY-RT GROUP Training sessions will be 3 times per week for 26 weeks. To parallel the FES-RT, the initial training sessions will also consist of 6 sets of arms-only rowing for five minutes at 60% of VO2peak with a work-to-rest ratio of 2:1 and progress over the six months to an exercise intensity of 75-85% maintained for 30 minutes performed three times each week. A maximum arms-only rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. A maximum arms-only rowing test will be performed at the end of the six months of training to determine increases in fitness.
- WAIT-LIST GROUP
The wait list group will not participate in any training for 6 months. A maximum arms-only rowing test will be performed immediately after enrollment, after initial familiarization with arms-only-RT equipment (usually 2-3 sessions) and will be repeated after 3 and 6 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three intervention groups (Control, AO-Row, and FES-RT) run in parallel
| Arm | Type | Receives |
|---|---|---|
| FES-row-training | Experimental | Other: FES-row-trainingSubjects will perform 6 months of FES-row-training. |
| Wait-list time control | Other | Other: Time ControlSubjects perform 6 months of their standard of care |
| Arms-only-row-training | Active comparator | Other: Arms-only-row trainingSubjects will perform 6 months of arms-only row training |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Spinal cord injured outpatients aged 18-40
- medically stable
- body mass index 18.5-30.0
- 3-12 months post SCI
- ASIA scale A, B or C at neurological level C5-T12
Key exclusion criteria (12 listed)
- hypertension
- significant arrhythmias
- coronary artery disease
- diabetes
- renal disease
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-training | Other | FES-row-training |
| Arms-only-row training | Other | Arms-only-row-training |
| Time Control | Other | Wait-list time control |
Primary outcome
Change From Baseline in Exercise Capacity at 6 Months
Time frame: Baseline and 6 months
Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.
Change From Baseline in Visceral Adiposity at 6 Months
Time frame: Baseline, 6 months
We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.
Change From Baseline in Myocardial Structure at 6 Months.
Time frame: Baseline and 6 months
Echocardiography was performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function.
Change From Baseline in Insulin Sensitivity at 6 Months.
Time frame: Baseline and 6 months
Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance.
Change From Baseline in Blood Lipids at 6 Months
Time frame: Baseline and 6 months
Blood will be taken via standard venipuncture to measure: total cholesterol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36622954Yates BA, Brown R, Picard G, Taylor JA. Improved pulmonary function is associated with reduced inflammation after hybrid whole-body exercise training in persons with spinal cord injury. Exp Physiol. 2023 Mar;108(3):353-360. doi: 10.1113/EP090785. Epub 2023 Jan 9.
- Derived from this study: PubMed 36572202Ely MR, Schleifer GD, Singh TK, Baggish AL, Taylor JA. Exercise Training Does Not Attenuate Cardiac Atrophy or Loss of Function in Individuals With Acute Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2023 Jun;104(6):909-917. doi: 10.1016/j.apmr.2022.12.001. Epub 2022 Dec 23.
- Derived from this study: PubMed 35077032Solinsky R, Schleifer GD, Draghici AE, Hamner JW, Taylor JA. Methodologic implications for rehabilitation research: Differences in heart rate variability introduced by respiration. PM R. 2022 Dec;14(12):1483-1489. doi: 10.1002/pmrj.12770. Epub 2022 Mar 12.
- Derived from this study: PubMed 33661958Solinsky R, Draghici A, Hamner JW, Goldstein R, Taylor JA. High-intensity, whole-body exercise improves blood pressure control in individuals with spinal cord injury: A prospective randomized controlled trial. PLoS One. 2021 Mar 4;16(3):e0247576. doi: 10.1371/journal.pone.0247576. eCollection 2021.
- Derived from this study: PubMed 33556347Ely MR, Singh TK, Baggish AL, Taylor JA. Reductions in Cardiac Structure and Function 24 Months After Spinal Cord Injury: A Cross-Sectional Study. Arch Phys Med Rehabil. 2021 Aug;102(8):1490-1498. doi: 10.1016/j.apmr.2021.01.070. Epub 2021 Feb 5.
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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, Ph.D. 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 and Arms-only-row training in people with Spinal Cord Injury, 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 12 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 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2022). 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?
Change From Baseline in Exercise Capacity at 6 Months (time frame: Baseline and 6 months). The study lists 5 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 NCT02139436, which also lists 5 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 22 Mar 2022.