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临床试验/NCT04770103
NCT04770103已完成不适用

Learning From Falling: Perturbation-based Training to Prevent Falls in Older Adults

Montana State University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年1月11日最近更新:
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
16
试验地点
1
主要终点
Margin of stability

研究概览

简要总结

The investigators will evaluate the difference between a commonly accepted paradigm of balance training (BT) and a more dynamic and task specific form of balance training, perturbation-based training (PBT) in older adults. BT is a key evidenced based strategy for preventing falls in older adults, however it needs to be regular (2hours/week) and long term (>6moths) while the average effect is only moderate (24%). The reason for the moderate effect on falls is like to be the non-specific stimulus presented during BT. That is, training tends to be quasi-static and slow and largely based on movements described as strength training. However, when an individual loses balance, they are most often required to implement a rapid and dynamic response. Furthermore, while older adults who are unable to recover balance well have generally lower strength, our recent work has demonstrated that it is not their force producing capability that limits them. Rather it is the ability to access moderate levels of muscular force very rapidly and early in the recovery step that differentiates successful versus unsuccessful recovery of balance. Importantly, the ability to produce an effective and rapid recovery step is predicative of avoiding future real world falls.

An emerging fall prevention training regimen is perturbation-based training (PBT). PBT involves rapidly disrupting balance requiring the participant to take rapid steps to recover balance. This is commonly achieved on a laboratory treadmill equipped with a safety harness to prevent actual falls during training. By simulating "real-world" balance challenges such as slips and trips, PBT provides a direct means for learning how to recover balance and avoid falls. It has been demonstrated that with only a few PBT sessions, older adults make rapid and dramatic improvements in balance recovery performance, retain the skills long-term and potentially suffer fewer falls over extended periods. This study builds on the previous published work of the PI that describes the key factors related to differences in balance recovery performance, the neuro-motor coordination strategies used during successful and unsuccessful recovery, and currently unpublished pilot studies indicating the efficacy of PBT. To date studies have not directly compared BT regimes recommended by the American College of Sports Medicine (ACSM) against PBT, nor have they evaluated the influence of training on the incidence of real-world falls. In part this may be because PBT currently requires the use of expensive, laboratory treadmills and as such is not accessible by the average independent, community dwelling older adults. A specific randomized study is required and our overall purpose for this study is to compare the balance recovery performance of older adults following either BT or PBT, evaluate differences in the incidence of real-world falls, and develop a safe, effective and portable device for use in future community PBT training studies. The short-term goals are to determine the effect of PBT versus BT and the neuro-motor mechanism of improved recovery behavior.

Aim 1: To evaluate differences in balance recovery behavior in older adults following either balance training (BT) and perturbation-based training (PBT) and the incidence on real-world falls.

H1: Balance recovery performance will improve in both BT and PBT groups but will be significantly better in those completing PBT when compared to BT.

H2: Improvements in balance recovery behavior will be related to improved coordination and neuro-motor control strategies.

H3: Real world loss of balance events will be similar in both BT and PBT but incidence of resulting falls will be lower in the PBT group.

详细描述

APPROACH

  1. The main study The main study to investigate the difference between BT and PBT is a parallel-group randomized controlled trial with 6 months follow-up from baseline to determine the effect of PBT program on stepping behavior and fall incidence in community-dwelling older people. The study has been designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement48.

Participants, recruitment and screening Participants will consist of community-dwelling adults aged over 65 years without a recent history of falls (one or more falls in the past 12 months). All participants will be required to obtain medical clearance from their general practitioner prior to participation in the study. Exclusion criteria will be neurological, cardiovascular or musculoskeletal impairment that adversely affect balance or limit involvement in the intervention, diagnosis of dementia, cognitive impairment (score<24 on Mini Mental State Examination after adjustment for age and years of education49), functional disability/limitation in activities of daily living (Score>3 on Bayer Activities of Daily Living Scale50), osteoporosis, use of medication that affects balance or causes dizziness (e.g. psychotropics) and participation in supervised exercise one or more times per week.

Random allocation and concealment Randomization will be performed following baseline assessment by personnel not involved in recruitment, training or assessments. Participants will be informed that they will receive one of two treatments. Due to the nature of the intervention, research personnel administering the treatments cannot be blinded to group allocation. However, the personnel that perform the prospective falls evaluation will be blinded to group allocation.

Intervention BT group. This group will undertake 12 weeks of twice weekly BT in accordance with ACSM guidelines. Training will be conducted in small groups under the supervision of a trainer. Training will involve mobility, resistance and balance training components.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •In order to take part in this study, you must meet all of the following criteria:
  • •Are aged 60 to 80 years
  • •Are living in the community
  • •Are a Non-smoker
  • •Do not have a recent muscle or joint injury
  • •Do not have a progressive musculoskeletal condition (arthritis, osteoporosis etc)

排除标准

  • •You will not be able to take part in this study if you meet any one of the following criteria:
  • •If you regularly consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription. If you are unsure about the drugs that you are taking, please ask us.
  • •You take medication that may make you dizzy or feel unbalanced, please consult with us regarding any prescribed medication you may be taking. Depending on the medication we may need screen you out of the study or ask that you to obtain clearance from your physician prior to being accepted into the study.
  • •A history of bone, joint, nerve, muscle problems or a current injury and are unable to obtain physician approval. This includes joint replacements or reconstructive surgery in the ankle, hip or knee joints.
  • •If you have had a stroke or have a heart condition for which moderate to vigorous exercise is contraindicated.
  • •If your doctor has told you that you should not do exercise.

研究组 & 干预措施

Dynamic

Experimental

Participants within the dynamic arm will receive either traditional balance training within ACSM guidelines or Dynamic Step training known as Perturbation based training (PBT). Outcome measures assessed will be Margin of Stability during dynamic step recovery when subjected to a forward loss of balance, along with static postural sway ( a measure of postural control not requiring a step recovery). Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.

干预措施: Balance recovery (Behavioral)

Static

Experimental

Participants within the static arm will receive only traditional balance training within ACSM guidelines. The outcome measure within the static arm is limited to static postural sway. Participants motivation, mental wellness, attitudes to exercise and fear of falling will be assessed prior to the intervention and 6 months following the intervention.

干预措施: Postural Sway (Behavioral)

结局指标

主要结局

Margin of stability

时间窗: 3 months

Margin of stability describes dynamic stability of an individual during stepping. It quantifies the location of the velocity adjusted center of mass compared to the base of support. Positive numbers reflect stability while negative numbers reflect instability. Margin of stability during balance recovery is related to future fall.

Step length

时间窗: 3 months

Difference in the length of the recovery step differentiate individuals who can successfully recover balance compared to those who cannot.

Step time

时间窗: 3 months

Difference in the time take to take a recovery step differentiate individuals who can successfully recover balance compared to those who cannot.

次要结局

  • Fall Incidence(6 months)
  • Fear of Falling(6 months)
  • Attitude towards exercise(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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