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The Feasibility of a Dynamic Exercise Intervention. Psychosocial Effects and Process Evaluation of the Experimental Design.

2021年8月6日 更新者:Nichola Davis、University of Derby

Evaluation of the Feasibility, Psychosocial Effects, Influence and Perception of Exercise Selection and Experimental Design of Exercises Performed.

Current balance and stability interventions have been shown to improve balance through targeting balance impairments and retraining effects. However, there are key facilitators and barriers 'that older adults may face to participate in such interventions'. Additionally, physical activity interventions fail to integrate older adults into the co-design and co-production of PA interventions.

The study will aim to identify the impact and practicalities of an exercise intervention in older adults by performing pre selected exercises with an elastic resistance band attached at the hip and chest region to challenge balance. Researcher led interviews will focus on the participants perceptions of the activities and decision making of exercise selection by selecting components that they are confident to perform which is a key element to creating a practical and enjoyable exercise programme for the older population. This will co-create an intervention that is accessible, acceptable, and appropriate for older adults.

The study will establish the accessibility, acceptability and appropriateness of an elastic band exercise intervention with older adults by performing selected activities followed by researcher led interviews that will focus on the participants influences, perceptions and psycho-social factors related the intervention activities.

研究概览

详细说明

Outline of study design The following study will be designed as a single exposure, qualitative (one-to-one interviews using a semi-structured interview guide) and quantitative (heart rate and rate of perceived exertion ratings) study. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will take part in one experimental session: performing exercises with an elastic resistance band placed at the hip and chest region. The session order of band placement will be randomized for each participant to counter-balance the outcome which emerge from the study.

Participant preparation Following a detailed briefing using a pre-prepared participant information sheet, a signed informed consent form and Instrumental Activities of Daily Living form, participants will be required to complete 2 supervised visits to the laboratory at the University of Derby.

Participants will complete a general health screening questionnaire. Specific instructions will be provided for participants to abstain from alcohol and caffeine for a minimum of 12/24 hours respectively and avoidance of strenuous exercise for at least 72 hours prior to participation.

Outline of study methods Participants will be required to attend the University Laboratory (Kblock) to take part in the study. Due to COVID-19 participants will be required to adhere to the latest government guidance and guidance from the University to consider this assessment to be safe (Risk assessments in place).

Baseline assessments:

  • Mini Balance Evaluation (MINI BESTest)
  • Short Falls Efficacy Scale (Short FES-I)

Following a briefing, participants will be required to perform a 10 minute supervised warm up and mobility session prior to exercise. Participants will be required to perform a selection of 8 pre-selected exercises whilst wearing the elastic band around the hip or chest region (randomized) with a 20 minute rest in between each condition). Participants will perform the exercises with the lowest resistance of 2-15lb aimed at low/moderate intensity. Heart rate (HR) on a heart rate strap and watch, rate of perceived exertion (RPE) (Borg scale) will be measured to assess exercise intensity.

All sessions will be closely supervised by the lead researcher -a qualified postural stability instructor, (level 4 reps Postural Stability Instructor trained by Later Life Training), that will provide prompts on form of the exercises.

Elastic band placement

Hip region:

Each participant will be required to perform the series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level which will be attached to the participant over the hip region with padding.

Chest region Each participant will be required to perform a series of exercises whilst attached to an elastic resistance band. The elastic band will be attached from ground level and to the participant over the chest region (under arms) , using Velcro on a chest harness/training vest.

Immediately following the single-session exercise intervention, participants will be required to attend a one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention.

研究类型

介入性

注册 (预期的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Derby、英国、de22 11gb
        • 招聘中
        • University of Derby

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants will be male and females over 50 years old. Although ageing is an individual and qualitative perspective rather than solely a chronological perspective, adults are transitioning to older adulthood in their 5th decade of life. Older adults may benefit from preparing at an earlier stage of ageing from the age of 50 years compared to beginning at the age of 65 years where falls are a high risk factor. PA guidelines recommend that adults will benefit from preparing physical attributes such as strength and balance at an earlier stage of the ageing process, therefore, this age group of 50 years and over has been selected as the most appropriate.
  • Moderately Physically active (this will be determined by the International Physical Activity Questionnaire (IPAQ) prior to participation of the study. A score of at least 600 MET-min/week (moderate physical activity level) will be required to take part in the study.
  • Ability to walk without a walking aid
  • Ability to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE) a score of under 23. The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired

Exclusion Criteria:

  • Individuals that are under the age of 50 years old
  • Individual that have serious, unstable cardiovascular conditions such as recent acute myocardial infarction; congestive heart failure; uncontrolled hypertension; serious musculoskeletal or neurologic conditions (including Parkinson's disease, Huntington's disease, acute stroke, paresis of the lower limbs and uncontrolled diabetes mellitus.
  • Individuals with acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are not physically active (METs score under 600 MET-min/week). have severe cognitive impairment (inability to follow simple training instructions; and acute respiratory tract infection or chronic lung disease (e.g. asthma and obstructive pulmonary disease).
  • Individuals that are unable to provide consent. This will be determined by using the Mini-Mental State Examination (MMSE)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Hip Region

Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed around the hip region.

Warm up: 5-10 mins

Exercises:

Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold.

Cool down. Post intervention- Semi-structured Interview schedule

A single exposure feasibility study using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
其他名称:
  • 弹力带训练
  • 老年人的平衡训练
  • 在老年人中使用阻力带进行稳定性训练
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • 老年人的新型弹性阻力带训练干预
  • Feasibility study on a Novel Elastic Resistance Band training Intervention
实验性的:Chest Region

Pre selected exercises (8) will be performed by the participant using an elastic resistance band anchored from ground level and placed the chest region (using velcro on a chest harness/training vest).

Warm up: 5-10 mins

Exercises:

Forward step, forward tandem steps, forward tandem hold, Upper body rotation, side steps. backward step, backward tandem walk, backward tandem hold.

Cool down. Post intervention- Semi-structured Interview schedule

A single exposure feasibility study using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
其他名称:
  • 弹力带训练
  • 老年人的平衡训练
  • 在老年人中使用阻力带进行稳定性训练
  • The feasibility of using Elastic Resistance Bands in Older Adults
  • 老年人的新型弹性阻力带训练干预
  • Feasibility study on a Novel Elastic Resistance Band training Intervention

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Semi structured Interview
大体时间:through study completion, an average of 1 year
A one-on-one, face to face semi-structured interview with the researcher to identify the impact and practicalities of the exercise intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. A semi-structured interview schedule developed by the lead researcher will investigate the acceptability, accessibility, appropriateness and usability of the protocol. Participants will be asked a series of open and closed questions and likert scales to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement. This will help to build insights into the participant preferences which is an important element of the intervention design.
through study completion, an average of 1 year
心率
大体时间:通过学习完成,平均1年
每次锻炼期间都会进行心率测量。 更高的值 = 每次锻炼的强度更高。 每分钟 50 次 - 120 = 低,每分钟 120-150 次 = 中等,每分钟 150 次 = 高。
通过学习完成,平均1年
Rate of perceived exertion (RPE)
大体时间:through study completion, an average of 1 year
RPE measures will be taken during each exercise. Scale 0-10. 0= no exertion and 10 being the highest exertion- exhaustion.
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
迷你天平评估测试(MINI-BESTest)
大体时间:通过学习完成,平均1年

该评估将要求参与者执行一系列体能任务。 在完成每项任务后,研究人员将记录分数以得出 MINI BESTest 的总分。 评分:该测试从 14 个项目中获得 28 分的最高分,每个项目的评分从 0-2 分。 “0”= 最低功能级别,“2”= 最高功能级别。

如果受试者必须为某个项目使用辅助设备,则将该项目评分降低一个类别。

如果受试者需要身体帮助来执行某项,则该项目得分为“0”。

通过学习完成,平均1年
Short Falls efficacy scale
大体时间:through study completion, an average of 1 year
This questionnaire will require the participant to answer 7 questions on their own perceptions on concerns of falling during a series of activities. The scale for each questions is measured from a value of 1-4. 1 = not concerned at all about falling and a 4 =very concerned about falling for each item. A higher score on the FES-l will represent a greater concern for falls from a participant (lowest score 7 and highest score 28).
through study completion, an average of 1 year

其他结果措施

结果测量
措施说明
大体时间
日常生活形式的器乐活动 (IADL)
大体时间:通过学习完成,平均1年

确定一个人目前的运作方式,以确定参与招募中的任何差异。 IADL 有 8 个类别,参与者需要从四个选项中选择一个,这些选项的分数分配给他们的功能水平(1 或 0)。 评分解释:在某些活动和类别中,只有最高级别的功能才能获得 1;在其他情况下,两个或多个级别的得分为 1,因为每个级别都描述了代表某种最低功能级别的能力。

这些屏幕对于具体指示一个人目前的表现非常有用。 因此,IADL 得分越高代表功能水平越高。 最高分 = 8(高功能),最低分 = 0(低功能)。

通过学习完成,平均1年
International physical activity questionnaire (IPARQ)
大体时间:through study completion, an average of 1 year

IPAQ assesses physical activity undertaken across a set of domains. The following values are used for the analysis: Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs.

Low= Individuals who not meet criteria for Categories 2 or 3 are considered to have a 'low' physical activity level.

Moderate= a) 3 or more days of vigorous-intensity activity of at least 20 minutes per day b) 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day c) 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week. High= a) vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week b) 7 or more days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum Total physical activity of at least 3000 MET-minutes/week.

through study completion, an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Andy Pringle, PhD、University of Derby

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月6日

初级完成 (预期的)

2021年10月1日

研究完成 (预期的)

2021年10月1日

研究注册日期

首次提交

2021年6月6日

首先提交符合 QC 标准的

2021年6月11日

首次发布 (实际的)

2021年6月21日

研究记录更新

最后更新发布 (实际的)

2021年8月9日

上次提交的符合 QC 标准的更新

2021年8月6日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UDerby

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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