Efficacy of a Toe Flexion Training Protocol on Older Adults' Mobility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- maximum isometric muscle force of flexion of the metatarsophalangeal (MTP) joints
研究概览
简要总结
This randomized controlled trial aims to explore the effect of a toe flexion resistance training protocol on toe flexion strength and morphology, as well as in older adults (65-85 completed years) mobility related construct. The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up.
详细描述
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a training intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
A centralized randomization will be performed at the 3rd visit so that participants do not know which group they will be assigned to during the control period.
Participants do not know which group they will be assigned to during the control period.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 60 and 85 completed years;
- •To be male or female;
- •To be in good health meaning to be in a complete state of physical, mental and social well-being with the absence of pathologies, pain or complaints to the lower limbs,
- •Be affiliated or beneficiary of a social security insurance;
- •Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
排除标准
- •Use of pharmacological therapy to match gander identity; Have a major comorbidity corresponding to a score >4 points on the Charlson Comorbidity Index (French Version);
- •Score <24 points in the MMSE-Fr;
- •Have spasticity or severe cerebellar ataxia in the leg;
- •Have an abnormal range of motion of the toes and/or ankle;
- •Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
- •Have a musculoskeletal injury that impairs walking or balance;
- •Have a high resting heart rate (> 90 beats per minute) and blood pressure > 144/94 mmHg;
- •Have a history of illness or conditions that would compromise the safety of the participant during the study;
- •Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
- •Being unable to understand the purpose and conditions of the study, and to give consent;
- •Being deprived of liberty or under guardianship.
结局指标
主要结局
maximum isometric muscle force of flexion of the metatarsophalangeal (MTP) joints
时间窗: Baseline to Week 18
the maximum isometric muscle force of joint flexion MTP (in N) measured with an ergometer composed of a 3-dimensional sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol. The measure is defined as the difference between the highest point and the baseline (week 1) in the signal time series.
次要结局
- Change from Baseline to Week 18 in Static postural balance(Baseline to Week 18)
- Change from Baseline to Week 18 in Fall Efficacy Scale (FES-Fr)(Baseline to Week 18)
- Change from Baseline to Month 4 in Force production of the foot complex(Baseline to Month 4)
- Change from Baseline to Week 18 in the distance covered in the "6-minute walk test" (in meters)(Baseline to Week 18)
- Change from Baseline to Week 18 in development of joint flexion strength(Baseline to Week 18)
- Change from Baseline to Week 18 in Deformation of the foot(Baseline to Week 18)
- Change from Baseline to Week 18 in Morphology of the foot muscles(Baseline to Week 18)
- Change from Baseline to Week 18 in the time taken during the "Time Up and Go Test"(Baseline to Week 18)
- Change from Baseline to Week 18 in Foot posture(Baseline to Week 18)
- Change from Baseline to Week 18 in Modified Falls Efficacy Scale (MFES-Fr)(Baseline to Week 18)