Exercise Training for People With Advanced Multiple Sclerosis

Официальное название

Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development

Обзор

The goal of this interventional study is to test the feasibility of 12 weeks of aerobic exercise for people with advanced multiple sclerosis (i.e., wheelchair users). The main questions it aims to answer are: * Is the exercise intervention feasible in terms of study processes, resources, management, safety, and acceptability? * Can the intervention improve aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, and sensation? * What are participants' experiences of taking part in the exercise intervention? Participants will take part in moderate-intensity aerobic exercise twice a week for 12 weeks in a supervised research setting. Outcomes will be measured at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-weeks after the intervention (24 weeks). The outcomes include feasibility measures, aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation, and participant experiences of taking part in the exercise intervention.

Подробное описание

Multiple sclerosis (MS) is a neurodegenerative disorder that results in the progressive accumulation of disability. Disability accumulation in MS is associated with the loss of physiological fitness, particularly cardiorespiratory fitness (CRF; i.e., the ability of the body to transport and use oxygen during activity). In MS, low CRF has been associated with worse motor and cognitive performance, symptoms, brain structure and plasticity, body composition, quality of life, and participation in daily activities. This emphasizes the need for treatment options that focus on the preservation of CRF.

Non-pharmacological approaches, such as exercise, are an essential component of comprehensive disease management in MS. Exercise training has been associated with numerous benefits in MS, including improvements in CRF and other fitness outcomes, mobility, symptoms, health-related quality of life, and participation in everyday activities. These benefits have primarily been established in people with MS who have mild-to-moderate disability levels (i.e., Expanded Disability Status Scale \[EDSS\] scores ≤ 6.5). As a result, the role of exercise for people with advanced MS (EDSS ≥ 7.0) is largely unknown.

This study aims to investigate the feasibility of aerobic exercise training for people living with advanced MS (i.e., EDSS ≥ 7.0). Participants will engage in moderate-intensity aerobic exercise (i.e., recumbent stepper, total body ergometer, and/or functional electrical stimulation leg cycle) twice a week for 12 weeks. Outcomes will be assessed at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-week follow-up (24 weeks). The outcome assessments include feasibility measures, efficacy outcomes (aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation), and participant experiences of taking part in the exercise intervention.

Вмешательства

• Поведенческое Aerobic Exercise Training
  Moderate intensity (40-59% heart rate reserve) aerobic exercise using a recumbent stepper, total body ergometer, and/or functional electrical stimulation leg cycle. Sessions will be delivered twice per week for up to 40 minutes per session for 12 weeks (i.e., up to 24 sessions total). Exercise will be prescribed based on individual fitness testing results and participant preferences, with progression in intensity and duration over 12-weeks.

Первичные конечные точки

• Feasibility - Recruitment duration [Срок оценки: Ongoing during the study recruitment period.]
• Feasibility - Recruitment methods [Срок оценки: Ongoing during the study recruitment period.]
• Feasibility - Recruitment screening time [Срок оценки: Ongoing during the study recruitment period.]
• Feasibility - Recruitment eligibility rate [Срок оценки: Ongoing during the study recruitment period.]
• Feasibility - Recruitment exclusion reasons [Срок оценки: Ongoing during the study recruitment period.]
• Feasibility - Adherence [Срок оценки: Ongoing during the 12-week intervention.]
• Feasibility - Compliance frequency [Срок оценки: Ongoing during the 12-week intervention.]
• Feasibility - Compliance duration [Срок оценки: Ongoing during the 12-week intervention.]
• Feasibility - Compliance intensity [Срок оценки: Ongoing during the 12-week intervention.]
• Feasibility - Attrition frequency [Срок оценки: Over the course of the 24-week study period.]

Вторичные конечные точки (12)

• Cardiorespiratory fitness [Срок оценки: Baseline and 12 weeks]
• Sensory function [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Function in daily life [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Physical function with a mobility aid [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Self-efficacy for managing chronic conditions [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Symptoms of fatigue [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Symptoms of pain [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Cognitive performance [Срок оценки: Baseline, 6, 12 and 24 weeks]
• Cognitive performance [Срок оценки: Baseline and 12 weeks]
• Cognitive performance [Срок оценки: Baseline and 12 weeks]
• Participant experiences of the intervention [Срок оценки: After the 12-week intervention.]
• Participant-reported outcomes related to the intervention [Срок оценки: Baseline and 12 weeks.]

Критерии участия

Критерии включения

• ≥18 years of age
• Self-reported diagnosis of MS
• Expanded Disability Status Score ≥ 7.0
• Stable course of disease-modifying therapy over past six months
• Physician approval for exercise participation

Критерии исключения

• Diagnosis of other neurological conditions
• Relapse within 30 days
• Signs or symptoms of acute or uncontrolled cardiovascular, renal or metabolic disease or other conditions that make it unsafe to exercise
• Currently engaging in regular aerobic exercise (≥ 2 sessions/week for ≥ 12 weeks)
• Additional exclusion criteria for functional electrical stimulation (FES) cycling exercise are cardiac demand pacemakers, implanted defibrillators, unhealed fractures, pregnancy, epilepsy, autonomic dysreflexia, and acute infections

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07546721 · H-11-24-11006 · 1416239

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗