- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07692191
Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kristine C Cowley, PhD
- Telefonnummer: +1 204-789-3305
- E-post: kristine.cowley@umanitoba.ca
Studera Kontakt Backup
- Namn: Rodrigo Villar, PhD
- Telefonnummer: +1-204-474-8590
- E-post: rodrigo.villar@umanitoba.ca
Studieorter
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3E 0J9
- Rekrytering
- University of Manitoba
-
Kontakt:
- Kristine Cowley, PhD
- Telefonnummer: +1-204-789-3305
- E-post: kristine.cowley@umanitoba.ca
-
Huvudutredare:
- Kristine Cowley, PhD
-
Huvudutredare:
- Rodrigo Villar, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- traumatic or non-traumatic spinal cord injury
- Spinal cord injury of at least one year duration, C5 or lower, AIS A - D
- medically stable and healthy enough to engage in and complete exercise requirements
- willing and able to complete the exercise protocols and testing requirements
- able to understand and follow written and verbal instructions from study staff
- able to communicate with study staff about their exercise capabilities and preferences
Exclusion Criteria:
- current serious injury (ies) of the upper extremities
- known cardiovascular disease
- unsatisfactory results of EKG screening
- implanted electronic cardiac devices (e.g., pacemaker, defibrillator, etc.)
- current pressure ulcer(s)
- morbid obesity
- known thyroid dysfunction
- current cancer
- current uncontrolled high blood pressure
- uncontrolled epilepsy
- current deep vein thrombosis
- ventilator dependency
- cognitive impairment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Upper body exercise in participants with tetraplegia
TSES during peak and steady state exercise in those with tetraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Övrig: Upper body exercise in participants with paraplegia
TSES during peak and steady state exercise in those with paraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Övrig: Upper body exercise in reference control participants
TSES during peak and steady state exercise in reference controls
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Övrig: Rhythmic lower limb neuromuscular electrical stimulation evoked exercise
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oxygen uptake
Tidsram: During individual study visits lasting between 1 and 2.5 hours
|
Oxygen uptake, in mL/min
|
During individual study visits lasting between 1 and 2.5 hours
|
|
Perceived Exertion
Tidsram: Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
|
Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
|
Time to fatigue during incremental exercise tests to fatigue
Tidsram: Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
|
Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
|
Heart rate
Tidsram: During exercise testing study visits, lasting between 1 and 3 hours
|
Heart rate, beats per minute
|
During exercise testing study visits, lasting between 1 and 3 hours
|
|
Power output
Tidsram: During exercise in study visits lasting 1 to 3 hours.
|
Watts
|
During exercise in study visits lasting 1 to 3 hours.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscle tissue oxygen saturation levels
Tidsram: Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
|
Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kristine Cowley, Phd, University of Manitoba
- Huvudutredare: Rodrigo Villar, PhD, University of Manitoba
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Sår och skador
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Övervikt
- Trauma, nervsystemet
- Ryggmärgssjukdomar
- Ryggskador
- Patologiska tillstånd, tecken och symtom
- Beteende
- Närings- och metabola sjukdomar
- Tecken och symtom
- Fetma
- Hjärt-kärlsjukdomar
- Ryggmärgsskador
- Ryggmärgsskador
- Motorisk aktivitet
Andra studie-ID-nummer
- HS26003
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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