NCT04066972已完成不适用
Intensive Aerobic and Task-specific Training to Restore Walking and Boost Neuroplasticity Among People With MS-related Walking Disability: a Proof of Principle Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of conducting vigorous cool room treadmill training
研究概览
简要总结
People with multiple sclerosis (MS) are often offered walking aids and compensatory strategies rather than restorative rehabilitation. We have developed a cool room treadmill training method that uses body-weight support that people with MS fatigue and heat sensitivity can tolerate. Our previous research shows that people with advanced MS use three times more energy for essential tasks such as walking. This project will test whether 10 weeks of body-weight supported treadmill training in a room cooled to 16°C improves walking, fitness and fatigue in people with advanced MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically definite MS
- •relapse-free in the previous 3 months
- •requiring ambulatory assistive devices (EDSS 6.0-7.0)
- •negative PAR-Q screen for risk factors
- •greater than 6-weeks post Botulinum Toxin injection (if received) in the lower extremity
排除标准
- •pregnancy or intention of becoming pregnant
- •finished a drug/device study in the last 30 days
- •over 75 years of age
- •unable to control bowel and bladder on physical exertion
- •currently attending physical rehabilitation
- •having no difficulty walking in the community (self-selected walking speed >120 cm/s)
研究组 & 干预措施
Single arm
Experimental
干预措施: Body-weight supported treadmill training in a room cooled to 16°C (Other)
结局指标
主要结局
Feasibility of conducting vigorous cool room treadmill training
时间窗: 10 weeks
Recruitment and retention rates
次要结局
- Timed 25 foot walk test(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Maximal oxygen consumption during graded exercise test(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Health-related quality of life assessed using 36-Item Short-Form Health Survey(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Serum interleukin-6(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Spatiotemporal parameters of gait measured while walking at fast and self-selected pace(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Fatigue severity scale(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Body composition measured using dual energy x-ray absorptiometry(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Modified fatigue impact scale(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Serum brain derived neurotrophic factor(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Montreal cognitive assessment(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Corticospinal excitability measured using transcranial magnetic stimulation(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Magnetization transfer ratio measured using magnetic resonance imaging(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Aerobic cost of walking(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
- Step counts(Following completion of the 10-week exercise intervention and 3-months post-exercise intervention)
研究者
Michelle Ploughman
Assistant Professor of Medicine
Memorial University of Newfoundland
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Training and Energy Management Education to Improve Quality of Life in Persons With Multiple SclerosisMultiple SclerosisNCT04356248Klinik Valens106
已完成
不适用
Individualized Physiotherapy and Activity Coaching for Multiple SclerosisMultiple SclerosisNCT04027114University of Saskatchewan120
招募中
不适用
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.BalanceCognitive ImpairmentMultiple SclerosisNCT05983809Fondazione Policlinico Universitario Agostino Gemelli IRCCS24
已完成
不适用
TRAIN-BW: Backward Walking Training in Multiple SclerosisGait Disorders, NeurologicAccidental FallMultiple SclerosisNCT04091464Wayne State University90
已完成
不适用
"Outwalk MS" - Benefits of Outdoor Walking in Multiple SclerosisMultiple SclerosisNCT05415956University of Aarhus60