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NCT05433103Toboroz

Blood Flow Restriction And Veterans With MS

Low-Load Resistance Training With Blood Flow Restriction in People With Multiple Sclerosis and Advanced Disability: A Randomized Control Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 23.

Rövid összefoglaló (regiszter, angolul)

There currently is a lack of evidence to support exercise interventions in people with advanced disability due to MS (i.e., need assistance to walk or use a wheelchair). This project proposes to study a strength training program using blood flow restriction (BFR) in people with advanced disability due to MS. BFR uses a device that partially blocks blood flow to the exercising limb and causes a response in the muscle which can replicate the effects of high-intensity training using much lower intensities. This is ideal for people with MS who have advanced disability, as they often cannot tolerate higher intensity exercise due to severe weakness and fatigue. By studying BFR training in people with advanced disability due to MS, the investigators hope to help improve strength, mobility, fatigue, and quality of life in people with MS. This study will target enrollment of Veterans with MS, who tend to have more advanced disability than non-Veterans with MS.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
58 (tervezett)
Első benyújtás
2022. jún. 21.
Kezdés
2023. jan. 1.
Elsődleges befejezés
2027. dec. 31.
Fő szponzor
VA Office of Research and Development
NCT-szám
NCT05433103

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 58
  • 2023. jan. 1. és az elsődleges befejezés (2027. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Engaged in progressive resistance training program currently or in the previous 2 months prior to enrollment.
  • Use of blood flow restriction currently or in the previous 2 months prior to enrollment.
  • MS-related exacerbation or changes to their disease-modifying drug therapy in the month prior to enrollment.

Más betegség

  • Moderate to Severe cognitive impairment as identified by the St. Louis University Mental Status Exam Score \<=20
  • History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia, clotting disorders
  • Any comorbid conditions or pain that substantially affects physical function or would interfere with the participant's ability to safely complete rehabilitation (e.g. neurologic, vascular, cardiac problems, orthopedic, or ongoing medical treatments) as determined by a neurologist or physical therapist

Egyéb

  • PDDS 8: Unable to sit in a wheelchair for more than one hour.
  • PDDS 3 or less: MS does not interfere with my activities, especially my walking. I can work a full day, but athletic or physically demanding activities are more difficult than they used to be. I usually don't need a can or other assistance to walk, but I might need some assistance during an attack.
  • Systolic BP \>= 180 mmHg or Diastolic BP \>= 110 mmHg.
  • Patient report of easy bruising
  • Severe lower extremity spasticity as defined as Modified Ashworth scale \>2.
  • Inability to tolerate pressure cuff during baseline assessment.
  • Unable to perform seated leg press exercise or no against gravity knee extension strength in at least one limb.

Kiket keres a vizsgálat

  • Confirmed diagnosis of MS
  • Age 18-75
  • Patient Determined Disease Steps (PDDS) 4 to 7
    • PDDS 4: Early cane: I use a cane or a single crutch or some other form of support (such as touching a wall or leaning on someone's arm) for walking all the time or part of the time, especially when walking outside. I think I can walk 25 feet in 20 seconds without a cane or crutch. I always need some assistance (cane or crutch) if I want to walk as far as three blocks.
    • PDDS 5: Late cane: To be able to walk 25 feet, I have to have a cane, crutch, or someone to hold onto. I can get around the house or other buildings by holding onto furniture or touching the walls for support. I may use a scooter or wheelchair if I want to go greater distances.
    • PDDS 6: Bilateral support: To be able to walk as far as 25 feet I must have two canes or crutches or a walker. I may use a scooter or wheelchair for longer distances.
    • PDDS 7: Wheelchair/scooter: My main form of mobility is a wheelchair. I may be able to stand and/or take one or two steps, but I can't walk 25 feet, even with crutches or a walker.

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Rocky Mountain Regional VA Medical Center, Aurora, CO
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AuroraEgyesült ÁllamokToboroz

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