Ćwiczenia aerobowe dla remielinizacji w stwardnieniu rozsianym
Ćwiczenia aerobowe poprawiające mobilność w stwardnieniu rozsianym: optymalizacja projektu i wykonania dla pełnowymiarowego multimodalnego badania klinicznego remielinizacji
This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.
Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.
This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Oregon
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Portland, Oregon, Stany Zjednoczone, 97239
- Oregon Health & Science University
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria
- 18-64 years old
- Have access to the internet and a device that can access virtual visits
- (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40
Exclusion Criteria:
- Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate.
- Engages in >30 minutes/week of aerobic activity regularly.
- Clinically confirmed MS relapse in the last 3 months.
- Changes in disease modifying therapy (DMT) for MS in the last 6 months.
- Pregnant women.
- Treatment with steroids for MS in the last 30 days.
- Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing.
- Have a known history of severe spinal canal stenosis
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: MS: Cycle
Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks. |
Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks. |
|
Aktywny komparator: MS: Take Control
Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator. |
A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Somatosensory Evoked Potentials
Ramy czasowe: From baseline to week 24
|
Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex of the brain). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged Z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 24 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis (MS). Those with an average Z-score of ≥2 were considered abnormal. |
From baseline to week 24
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
6-Minute Timed Walk (6MTW)
Ramy czasowe: From baseline to week 24
|
An assessment of exercise tolerance |
From baseline to week 24
|
|
Timed Up and Go (TUG)
Ramy czasowe: From baseline to week 24
|
A test of walking agility |
From baseline to week 24
|
|
Timed 25-Foot Walk (T25FW)
Ramy czasowe: From baseline to week 24
|
A test of walking speed |
From baseline to week 24
|
|
9 Hole Peg Test
Ramy czasowe: From baseline to week 24
|
A test of upper extremity and arm function. Average of both upper extremity times in seconds. |
From baseline to week 24
|
|
Multiple Sclerosis Functional Composite (MSFC)
Ramy czasowe: From baseline to week 24
|
The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability. |
From baseline to week 24
|
|
Virtual Aerobic Exercise Intervention Adherence
Ramy czasowe: From baseline to week 24
|
Defined as participation in at least 80% of the exercise sessions in the trial |
From baseline to week 24
|
|
Virtual Education Control Group Adherence
Ramy czasowe: From baseline to week 24
|
Defined as participation in at least 80% of the education group sessions in the trial |
From baseline to week 24
|
|
Average Minutes Spent at Goal Heart Rate (HR) During Exercise
Ramy czasowe: From baseline to week 24
|
Average number of minutes per session that MS: Cycle participants spent in their goal HR zone (>=70% HR max) during exercise sessions. |
From baseline to week 24
|
|
Brain Myelin Water Fraction (MWF)
Ramy czasowe: From baseline to week 24
|
MWF imaging of the corpus callosum, internal capsule, thalamus, and frontal white matter. |
From baseline to week 24
|
|
Symbol Digit Modalities Test (SDMT)
Ramy czasowe: From baseline to week 24
|
The Symbol Digit Modalities Test (SDMT) is a test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score. |
From baseline to week 24
|
|
VO2 Max
Ramy czasowe: From baseline to week 24
|
A test of aerobic fitness |
From baseline to week 24
|
|
Modified Fatigue Impact Scale (MFIS)
Ramy czasowe: From baseline to week 24
|
A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue). |
From baseline to week 24
|
|
Quality of Life in Neurological Disorders (Neuro-QoL)
Ramy czasowe: From baseline to weeks 24
|
Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower Self Efficacy scores. |
From baseline to weeks 24
|
|
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Ramy czasowe: From baseline to week 24
|
A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week. |
From baseline to week 24
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
6-Minute Timed Walk (6MTW)
Ramy czasowe: From baseline to week 12
|
An assessment of exercise tolerance |
From baseline to week 12
|
|
Timed Up and Go (TUG)
Ramy czasowe: From baseline to week 12
|
A test of walking agility |
From baseline to week 12
|
|
Timed 25-Foot Walk (T25FW)
Ramy czasowe: From baseline to week 12
|
A test of walking speed |
From baseline to week 12
|
|
9 Hole Peg Test
Ramy czasowe: From baseline to week 12
|
A test of upper extremity and arm function. Average of times for both upper extremities. |
From baseline to week 12
|
|
Multiple Sclerosis Functional Composite (MSFC)
Ramy czasowe: From baseline to week 12
|
The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability. |
From baseline to week 12
|
|
Symbol Digit Modalities Test (SDMT)
Ramy czasowe: From baseline to week 12
|
The Symbol Digit Modalities Test (SDMT) test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score. |
From baseline to week 12
|
|
Modified Fatigue Impact Scale (MFIS)
Ramy czasowe: From baseline to week 12
|
A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue). |
From baseline to week 12
|
|
Somatosensory Evoked Potentials (SSEPs)
Ramy czasowe: From baseline to week 12
|
Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 12 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis. Those with an average Z-score of ≥2 were considered abnormal. |
From baseline to week 12
|
|
Quality of Life in Neurological Disorders (Neuro-QoL)
Ramy czasowe: From baseline to weeks 12
|
Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower self efficacy scores. |
From baseline to weeks 12
|
|
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Ramy czasowe: From baseline to week 12
|
A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week. |
From baseline to week 12
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Lindsey B Wooliscroft, MD, Oregon Health and Science University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Procesy patologiczne
- Choroby Autoimmunologiczne
- Choroby układu odpornościowego
- Leukoencefalopatie
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Stwardnienie rozsiane
- Skleroza
- Choroby Układu Nerwowego
- Choroby Autoimmunologiczne Układu Nerwowego
- Choroby demielinizacyjne
- Demielinizacyjne choroby autoimmunologiczne, OUN
- Aktywność silnika
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Ćwiczenia
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- STUDY00021045
- K23HD101667 (Grant/umowa NIH USA)
- UL1TR002369 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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