Helping Older People Recover Walking Abilities Through Arm-in-armg Gait Training: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Walking speed
研究概览
简要总结
The AAGaTT study, is a monocentric, two-arm, open-label, randomized controlled trial. The objective is to assess the efficacy of an arm-in-arm walking program for older people at risk of falling. Gait training imply that the older participants must walk while synchronizing steps with a younger partner.
详细描述
A high level of physical activity is the cornerstone of healthy aging. Falls are a major issue in elderly population, and exercising can mitigate their occurrence. However, the type of exercise-and the optimal way to deliver it-that maximises efficacy is still unknown. The ideal-most efficient-exercise intervention should have the following characteristics: it should have a specific effect on fall risk mitigation, it should be of sufficient intensity to improve cardiovascular fitness and muscle strength, it should be safe, it should not induce high costs, and it should be sufficiently enjoyable and motivational to induce a high adherence and compliance. The present trial aims at testing an innovative exercise intervention that may exhibit all these advantages.
The intervention will consist in four weeks of 30min arm-in-arm synchronized gait training three times a week. Convincing evidence from the literature supports the use of rhythmic externals cues, either auditory or visual, to improve the efficacy of gait training for fall risk reduction in seniors. Synchronizing gait with a younger partner may bring further benefits.
We will focus on clinically relevant outcomes to highlight potential benefits of the intervention in term of gait quality, balance, fall risk mitigation, physical activity level, mood, and well-being.
Gait quality will be assessed through two inertial sensors attached to the low back and foot. Six gait assessement sessions are planned: at baseline (before randomization), at the end of each training week, and at week 7 (follow-up). Participants will walk at their preferred speed over 200m.
We will also include functional tests and self-filled questionnaires to evaluate participant's abilities and mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Blinding is not possible due to the nature of the intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older Participant
- •Older than 70 years old
- •Able to walk continuously during 15 minutes without walking aids.
- •Must have experienced a fall during the last year before the recruitment.
- •Health certificate that attests no contraindication to walking
- •No severe gait disorders from orthopedic or neurologic origins (such as lower-limb amputation or severe hemiparesis). Mild gait abnormalities (for example, mild limping due to knee arthritis, or slight gait asymmetry due to limited hemiparesis) will be tolerated.
- •Younger Participant
- •Older than 18 years old but younger than 40 years old.
- •No severe gait disorders from musculoskeletal or neurologic origin.
排除标准
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.;
- •Inability or contraindications to undergo the investigated intervention.
- •Vulnerable persons, in sense of swiss Human Research Act art. 21-24.
结局指标
主要结局
Walking speed
时间窗: Week 4
Habitual (preferred) walking speed to cover 200m. Normal values for older men: 1.21m/s -1.32m/s), older women 1.07m/s -1.19m/s).
次要结局
- Average step frequency(Baseline)
- Gait attentional demand(Week 7 (follow-up))
- Time to perform Timed up-and-go (TUG) test.(Week 3)
- Walking speed(Week 7 (follow-up))
- Step symmetry(Week 7 (follow-up))
- Stride regularity(Week 7 (follow-up))
- Fractal index(Week 7 (follow-up))
- Score at the Geriatric Depression Scale (GDS)(Week 7 (follow-up))
- Score at the Falls Efficacy Scale International (FES-I)(Week 7 (follow-up))
- Level of physical activity over the last seven days(Week 7 (follow-up))
- Average time held on a leg obtained following the Unipedal stance test(Week 4)
- Average time held on a leg obtained accordion to the Unipedal stance test(Week 7 (follow-up))
- Number of falls over three month(Between 3 and 6 months after the end of the training program (week 4).)
- Number of participants withdrawing from the study(Week 7 (follow-up))
- Step frequency(Week 7 (follow-up))
- Step length(Week 7 (follow-up))
- Time to perform the Timed up-and-go (TUG) test.(Week 7 (follow-up))
- Number of falls over the past year(Baseline)
- Perception of the training program(Week 4)
- Gait Stability(Week 7 (follow-up))
- Stride time variability(Week 7 (follow-up))
- Measure of the quality of life and well-being(Week 4)
- Number of falls over three months(Between 12 and 18 months after the end of the training program (week 4).)
研究者
Philippe Terrier
Assistant professor
Haute Ecole ARC Sante