Healthy Young AdultsNCT06860464
Remote Ischemic Conditioning and Spinal Reflex Modulation
A study testing Remote Ischemic Condtioning (RIC) and Balance training in people with Healthy Young Adults, run by East Carolina University at 1 site in United States.
Trial summary
Remote ischemic conditioning (RIC) is a clinically feasible method that protects distant organs from severe injury through brief, sub lethal periods of ischemia followed by re-perfusion. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Remote Ischemic Condtioning (RIC) and Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18-40 years of age
Who cannot join
- Individuals with cognitive deficits or communication problems
- Individuals with impaired vision
- Individuals with balance disorders such as vestibular disorders, etc.
- Individuals who are pregnant
- Individuals with known cardiorespiratory dysfunctions
- Presence of lower extremity condition, injury, or surgery within last three months which could compromise training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Remote Ischemic Conditioning Combined With Motor Training on Spinal Reflex Modulation in Healthy Young Adults
Remote ischemic conditioning (RIC) is a clinically feasible method that protects distant organs from severe injury through brief, sub lethal periods of ischemia followed by re-perfusion. Recent studies suggest that RIC, combined with training, improves muscle strength and balance in healthy adults and post-stroke survivors. While the underlying mechanisms are not fully understood, RIC's neuroprotective effects - such as promoting angiogenesis, neurogenesis, and modulating glutamate and GABA synthesis - overlap with neuroplasticity processes. Evidence indicates that neuroplasticity from exercise training occurs not only in the cerebral cortex but also within the spinal cord, yet the role of spinal reflex mechanisms underlying the benefits of RIC remains under explored. Therefore, this study aims to investigate effects of RIC on spinal reflex modulation in healthy adults, both independently and combined with balance training.
Read the detailed description
Ischemic conditioning (IC) is an endogenous phenomenon that protects target organs from severe ischemic events by applying alternating cycles of brief, sublethal ischemia followed by reperfusion. Remote ischemic conditioning (RIC) is a more feasible, non-invasive method of delivering IC. It involves using a standard blood pressure cuff on either the arm or leg to induce brief periods of sublethal ischemia. Extensive evidence from both animal and human studies indicates that RIC provides neuroprotection through multifactorial mechanisms involving inflammatory, oxidative, excitotoxic, metabolic, vascular, and glial pathways. Additionally, several studies demonstrate the involvement of peripheral somatosensory, spinal cord, and autonomic pathways in RIC-induced neuroprotection. Prior research also shows that RIC enhances motor learning (balance performance) when paired with motor training in both young and older adults. While a wealth of research has shown that neuroplasticity in response to training occurs in cortical and spinal neural circuits, limited studies have explored the effects of RIC on spinal modulations in healthy adults. Notably, only one study has reported a reduction in Hoffman (H)-reflex amplitudes with RIC. Given the evidence of peripheral neuronal pathways involved in RIC and its positive impact on balance performance, it is plausible that RIC could lead to spinal reflex modulations and enhance balance improvements in healthy adults. These modulations may be further amplified when RIC is combined with balance training. The specific aims of this study are to determine whether 1) remote ischemic conditioning (RIC) combined with balance training modulates spinal reflex excitability, as reflected by H-reflex measures, and 2) to examine whether RIC combined with balance training leads to greater improvements in balance performance compared to sham conditioning combined with training in healthy adults. In this single-blind, randomized controlled trial, 30 healthy adults aged 18-40 years will undergo H-reflex testing of the dominant lower extremity and balance assessments at baseline (pre-training). Participants will then be randomized to receive either RIC or sham conditioning combined with a 5-day balance training program. RIC or sham conditioning will be delivered using cyclic inflation and deflation of a pressure cuff applied to the thigh of the dominant lower extremity following a standardized protocol. Balance training will consist of standing on a stability platform with the goal of maintaining the platform within a 5-degree horizontal range for 30 seconds across 15 trials per day for five consecutive days. All outcome measures, including H-reflex parameters (Hmax, maximal H-reflex amplitude, and Hmax/Mmax ratio) and balance performance, will be reassessed post-training following completion of the 5-day intervention. It is hypothesized that, compared to sham conditioning combined with balance training, RIC combined with balance training will result in greater reductions in H-reflex excitability and greater improvements in balance performance from baseline to post-training. This study will help clarify whether RIC induces alterations in spinal reflex modulations when applied independently or in combination with motor training, thereby reflecting neuroplasticity within the spinal cord in healthy young adults. These findings would deepen our understanding of the spinal mechanisms underlying the benefits of RIC and could accelerate its translation for individuals with neurological disorders
- Conditions
- Healthy Young Adults
- Being tested
- Remote Ischemic Condtioning (RIC), Sham Conditioning, Balance training
- Keywords
- Remote ischemic conditioning, Spinal reflex modulation, H-reflex, Balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Condtioning (RIC)Behavioural
See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are RIC plus training visits.
Sham ConditioningBehavioural
See descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are Sham plus training visits.
Balance trainingBehavioural
All participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 2-6.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning (RIC) | Experimental | RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the thigh of dominant LE. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2 - 6. Receives: Behavioral: Remote Ischemic Condtioning (RIC); Behavioral: Balance training |
| Sham conditioning | Sham comparator | Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the dominant LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 2-6. Receives: Behavioral: Sham Conditioning; Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal H-reflex amplitude (Hmax)
The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.
Measured: Baseline, Day 7
Change in Hmax/ Mmax Ratio
The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.
Measured: Baseline, Day 7
Secondary outcomes (1)
Change in Balance Performance
The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each. The total score will range between 0-30 seconds. Higher balance score indicates better balance performance. Greater average balance time indicates better balance performance.
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start6 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swati Manoharrao Surkar, East Carolina University
- Investigators
- Swati M Surkar, PT, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860464
- Sponsor's protocol ID
- UMCIRB 23-001021
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on NIH figshare network and will be made available on request.
Publications
Taube W, Kullmann N, Leukel C, Kurz O, Amtage F, Gollhofer A. Differential reflex adaptations following sensorimotor and strength training in young elite athletes. Int J Sports Med. 2007 Dec;28(12):999-1005. doi: 10.1055/s-2007-964996. Epub 2007 May 11.
PubMed 17497570Quadrado IC, Cancio RB, Silva BM, Vianna LC, Mezzarane RA. Modulation of spinal cord excitability following remote limb ischemic preconditioning in healthy young men. Exp Brain Res. 2020 May;238(5):1265-1276. doi: 10.1007/s00221-020-05807-w. Epub 2020 Apr 17.
PubMed 32303809Surkar SM, Bland MD, Mattlage AE, Chen L, Gidday JM, Lee JM, Hershey T, Lang CE. Effects of remote limb ischemic conditioning on muscle strength in healthy young adults: A randomized controlled trial. PLoS One. 2020 Feb 4;15(2):e0227263. doi: 10.1371/journal.pone.0227263. eCollection 2020.
PubMed 32017777Dirnagl U, Becker K, Meisel A. Preconditioning and tolerance against cerebral ischaemia: from experimental strategies to clinical use. Lancet Neurol. 2009 Apr;8(4):398-412. doi: 10.1016/S1474-4422(09)70054-7.
PubMed 19296922Kharbanda RK, Nielsen TT, Redington AN. Translation of remote ischaemic preconditioning into clinical practice. Lancet. 2009 Oct 31;374(9700):1557-65. doi: 10.1016/S0140-6736(09)61421-5.
PubMed 19880021
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning Combined With Motor Training on Spinal Reflex Modulation in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06860464
- Acronym / sponsor ID
- UMCIRB 23-001021
- Conditions
- Healthy Young Adults
- Keywords
- Remote ischemic conditioning, Spinal reflex modulation, H-reflex, Balance training
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Mar 2025 (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.
Remote ischemic conditioning (RIC) is a clinically feasible method that protects distant organs from severe injury through brief, sub lethal periods of ischemia followed by re-perfusion. Recent studies suggest that RIC, combined with training, improves muscle strength and balance in healthy adults and post-stroke survivors. While the underlying mechanisms are not fully understood, RIC's neuroprotective effects - such as promoting angiogenesis, neurogenesis, and modulating glutamate and GABA synthesis - overlap with neuroplasticity processes. Evidence indicates that neuroplasticity from exercise training occurs not only in the cerebral cortex but also within the spinal cord, yet the role of spinal reflex mechanisms underlying the benefits of RIC remains under explored. Therefore, this study aims to investigate effects of RIC on spinal reflex modulation in healthy adults, both independently and combined with balance training.
Detailed description
Ischemic conditioning (IC) is an endogenous phenomenon that protects target organs from severe ischemic events by applying alternating cycles of brief, sublethal ischemia followed by reperfusion. Remote ischemic conditioning (RIC) is a more feasible, non-invasive method of delivering IC. It involves using a standard blood pressure cuff on either the arm or leg to induce brief periods of sublethal ischemia. Extensive evidence from both animal and human studies indicates that RIC provides neuroprotection through multifactorial mechanisms involving inflammatory, oxidative, excitotoxic, metabolic, vascular, and glial pathways. Additionally, several studies demonstrate the involvement of peripheral somatosensory, spinal cord, and autonomic pathways in RIC-induced neuroprotection. Prior research also shows that RIC enhances motor learning (balance performance) when paired with motor training in both young and older adults. While a wealth of research has shown that neuroplasticity in response to training occurs in cortical and spinal neural circuits, limited studies have explored the effects of RIC on spinal modulations in healthy adults. Notably, only one study has reported a reduction in Hoffman (H)-reflex amplitudes with RIC. Given the evidence of peripheral neuronal pathways involved in RIC and its positive impact on balance performance, it is plausible that RIC could lead to spinal reflex modulations and enhance balance improvements in healthy adults. These modulations may be further amplified when RIC is combined with balance training. The specific aims of this study are to determine whether 1) remote ischemic conditioning (RIC) combined with balance training modulates spinal reflex excitability, as reflected by H-reflex measures, and 2) to examine whether RIC combined with balance training leads to greater improvements in balance performance compared to sham conditioning combined with training in healthy adults. In this single-blind, randomized controlled trial, 30 healthy adults aged 18-40 years will undergo H-reflex testing of the dominant lower extremity and balance assessments at baseline (pre-training). Participants will then be randomized to receive either RIC or sham conditioning combined with a 5-day balance training program. RIC or sham conditioning will be delivered using cyclic inflation and deflation of a pressure cuff applied to the thigh of the dominant lower extremity following a standardized protocol. Balance training will consist of standing on a stability platform with the goal of maintaining the platform within a 5-degree horizontal range for 30 seconds across 15 trials per day for five consecutive days. All outcome measures, including H-reflex parameters (Hmax, maximal H-reflex amplitude, and Hmax/Mmax ratio) and balance performance, will be reassessed post-training following completion of the 5-day intervention. It is hypothesized that, compared to sham conditioning combined with balance training, RIC combined with balance training will result in greater reductions in H-reflex excitability and greater improvements in balance performance from baseline to post-training. This study will help clarify whether RIC induces alterations in spinal reflex modulations when applied independently or in combination with motor training, thereby reflecting neuroplasticity within the spinal cord in healthy young adults. These findings would deepen our understanding of the spinal mechanisms underlying the benefits of RIC and could accelerate its translation for individuals with neurological disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning (RIC) | Experimental | Behavioral: Remote Ischemic Condtioning (RIC), Behavioral: Balance trainingRIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the thigh of dominant LE. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2 - 6. |
| Sham conditioning | Sham comparator | Behavioral: Sham Conditioning, Behavioral: Balance trainingSham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the dominant LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 2-6. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults 18-40 years of age
Key exclusion criteria (6 listed)
- Individuals with cognitive deficits or communication problems
- Individuals with impaired vision
- Individuals with balance disorders such as vestibular disorders, etc.
- Individuals who are pregnant
- Individuals with known cardiorespiratory dysfunctions
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 |
|---|---|---|
| Remote Ischemic Condtioning (RIC)See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are RIC plus training visits. | Behavioural | Remote Ischemic Conditioning (RIC) |
| Sham ConditioningSee descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are Sham plus training visits. | Behavioural | Sham conditioning |
| Balance trainingAll participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 2-6. | Behavioural | Remote Ischemic Conditioning (RIC), Sham conditioning |
Primary outcome
Change in maximal H-reflex amplitude (Hmax)
Time frame: Baseline, Day 7
The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.
Change in Hmax/ Mmax Ratio
Time frame: Baseline, Day 7
The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.
1 secondary outcome
Change in Balance Performance
Time frame: Baseline, Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 17497570Taube W, Kullmann N, Leukel C, Kurz O, Amtage F, Gollhofer A. Differential reflex adaptations following sensorimotor and strength training in young elite athletes. Int J Sports Med. 2007 Dec;28(12):999-1005. doi: 10.1055/s-2007-964996. Epub 2007 May 11.
- Background: PubMed 32303809Quadrado IC, Cancio RB, Silva BM, Vianna LC, Mezzarane RA. Modulation of spinal cord excitability following remote limb ischemic preconditioning in healthy young men. Exp Brain Res. 2020 May;238(5):1265-1276. doi: 10.1007/s00221-020-05807-w. Epub 2020 Apr 17.
- Background: PubMed 32017777Surkar SM, Bland MD, Mattlage AE, Chen L, Gidday JM, Lee JM, Hershey T, Lang CE. Effects of remote limb ischemic conditioning on muscle strength in healthy young adults: A randomized controlled trial. PLoS One. 2020 Feb 4;15(2):e0227263. doi: 10.1371/journal.pone.0227263. eCollection 2020.
- Background: PubMed 19296922Dirnagl U, Becker K, Meisel A. Preconditioning and tolerance against cerebral ischaemia: from experimental strategies to clinical use. Lancet Neurol. 2009 Apr;8(4):398-412. doi: 10.1016/S1474-4422(09)70054-7.
- Background: PubMed 19880021Kharbanda RK, Nielsen TT, Redington AN. Translation of remote ischaemic preconditioning into clinical practice. Lancet. 2009 Oct 31;374(9700):1557-65. doi: 10.1016/S0140-6736(09)61421-5.
- Individual participant dataSharing planned: Yes. Data will be shared on NIH figshare network and will be made available on request.
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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.
Swati M Surkar, PT, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Condtioning (RIC) and Balance training in people with Healthy Young Adults, run by East Carolina University 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 6 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: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 in maximal H-reflex amplitude (Hmax) (time frame: Baseline, Day 7). The study lists 2 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 NCT06860464, 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 16 Jan 2026.