跳至主要内容
临床试验/NCT05526508
NCT05526508招募中不适用

Use of Rebound Exercise in Community-dwelling Individuals With Neurological Disorders

Buckinghamshire New University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
2
主要终点
Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks

研究概览

简要总结

This study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.

详细描述

Neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. These impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. Rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. It can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. Its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. It is also more affordable and less time-consuming than other standard modalities. The few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. It is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. This study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. The enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice.

Ethical approval has been sought and obtained from the Research Ethics Committee of Buckinghamshire New University. Eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. They will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.

研究设计

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

盲法说明

Only the outcome assessor will be blinded to the participant's frequency group

入排标准

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

入选标准

  • •Clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, Parkinson's disease, traumatic brain injury etc
  • •must score 3 or less on the Modified Rankin Scale for disability status
  • •must be able to walk with or without walking aids for at least 2 minutes
  • •have a body weight of <120 kg
  • •must be able to understand therapy instructions.

排除标准

  • •Pregnancy
  • •Other significant comorbidities
  • •cardiovascular or respiratory system disorders
  • •musculoskeletal disorders
  • •visual or auditory sensory disorders.
  • •genu recurvatum

研究组 & 干预措施

Rebound once-weekly

Experimental

This group will undergo 12 weeks of rebound exercise training once weekly, for 30 minutes per session.

干预措施: Rebound exercise (Device)

Rebound twice-weekly

Experimental

This group will undergo 12 weeks of rebound exercise training twice weekly, for 30 minutes per session.

干预措施: Rebound exercise (Device)

结局指标

主要结局

Change in baseline walking speed assessed by 10-Metre Walk test (10MWT) at 12 weeks

时间窗: Baseline and 12 weeks

10MWT has been shown to have excellent construct validity and reliability for patients with neurological diseases (Cheng et al., 2020). The individual is instructed to walk a set distance of 10 meters, and the time taken to walk the distance is noted. Assistive devices may be used but must be documented from test to test. Walking distance is measured in meters per second.

Change in baseline risk of fall assessed by 3-Metre Backward Walk test at 12 weeks

时间窗: Baseline and12 weeks

3-metre backward walk test (3MBWT) is valid, reliable and clinically suitable to detect little changes in motor functions related to proprioception in patients with neurological diseases (Kocaman et al., 2021). Of all battery tests assessed for fall risks in patients with Parkinson's disease (Carter et al., 2020), 3MBWT had the highest overall accuracy for retrospective falls. Backward walking measures are more sensitive to identify age-related changes in mobility than forward walking. From a marked point, the patient is asked to walk backwards as fast and safely as possible to a 3-metre marked end. They are free to look back if they wish. A time of 3 seconds or less indicates good balance and low fall risk, while a time of 4.5 seconds or more indicates a high fall risk.

Change in baseline physical activity level assessed by International Physical Activity Questionnaire at 12 weeks

时间窗: Baseline and 12 weeks

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. The IPAQ can be used clinically and in population research that compares physical activity levels between populations internationally.

Change in baseline blood pressure and heart rate assessed by digital blood pressure monitor at 12 weeks

时间窗: Baseline and 12 weeks

A digital Blood pressure monitor uses an inflatable air-bladder cuff, a battery-powered air pump and a pressure sensor for sensing arterial wall vibrations to measure blood pressure in an artery.

Change in baseline quality of life assessed by World Health Organisation Quality of Life Brief version (WHOQOLBREF) at 12 weeks

时间窗: Baseline and12 weeks

WHOQOLBREF is a 12-item questionnaire assessing physical and psychological domains of quality of life. The scale has been validated among stroke patients of different ethnic groups (Kerber et al., 2013; Post et al., 2011). It is rated on a 5-point Likert scale ranging from 1-5, with higher scores indicating better quality of life. A significant advantage it has over the more extended version is its reduced administration time (5 minutes), making it a more practical tool in research and clinical practice.

Change in baseline cognitive function assessed by mini-cog at 12 weeks

时间窗: Baseline and 12 weeks

The Mini-Cog is a simple screening test for cognitive impairment. It combines a brief memory test and a scored clock-drawing test. It allows rapid screening for short-term memory defects, learning and different cognitive abilities impaired in dementia patients.

次要结局

  • Change in baseline grip strength assessed with a digital handheld dynamometer at 12 weeks(Baseline and 12 weeks)

研究者

发起方
Buckinghamshire New University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adaora Okemuo

Associate Lecturer, PhD research student, School of Health and Social Care Professions

Buckinghamshire New University

研究点 (2)

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