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临床试验/NCT05224362
NCT05224362已完成不适用

Acute Effects of Elastic Band Resistance Applied to the Hip and Chest Region on Postural Stability and Physical Function Before, Immediately and up to 30 Min After Exercise in Physically Active Older Adults

University of Derby4 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
4
主要终点
Semi structured Interview

研究概览

简要总结

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. Static posturography will assess the impacts of the exercise intervention on balance and stability.

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 physical impact and practicalities of a novel elastic band resistance exercise intervention in older adults by performing force plate posturography and researcher led interviews that will focus on the participants perceptions of the activities and intensity levels to co-create an intervention that is accessible, acceptable, and appropriate for older adults.

详细描述

Outline of study designThe following study will be a repeated measures design. A convenience sample of adults/older adults will be recruited through PA networks in the Derbyshire community. Participants will not be recruited through HSN facilities or via any NHS platform. Participants will be required to attend three separate sessions with at least 48-72hours in between each session. Each session will be randomized in order to mitigate any bias and allow comparability of the 3 conditions. Experimental session one: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the hip region. Experimental session two: Participants will be required to perform pre-selected exercises with an elastic resistance band placed at the chest region. Experimental session three (control group): Participants will be required to perform pre-selected exercises without an elastic resistance band. The exercise intensity is measured throughout by RPE before, during and after each exercise.

intensity. Participants will be asked to simply perform the exercises not at any specific intensity. Force plate posturography measurements will be recorded before and immediately after and 30 minutes after the exercise intervention. The other quantitative measures (heart rate, rate of perceived exertion) will be recorded throughout the intervention and one-to-one interviews using a semi structured interview guide will be performed at the end of each session. The session order will be randomized for each participant to counterbalance the outcome which emerge from the study.

Participant preparation will include a detailed invitation to attend and briefing using a pre-prepared participant information sheet. Participants will be required to complete and return an International physical activity questionnaire, Falls efficacy scale, Confidence in maintaining balance and Instrumental Activities of Daily Living form.

Upon arrival of each session participants will be required to read and sign an informed consent form, a general health screen questionnaire and mini mental state examination. Participants will be required to complete all 3 sessions which will be supervised in the Kirtley building laboratory at the University of Derby (3 x experimental trial). 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • The MMSE will assess cognitive function using scoring to ensure that participants are not cognitively impaired

排除标准

  • 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).

结局指标

主要结局

Semi structured Interview

时间窗: 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.

Heart rate

时间窗: through study completion, an average of 1 year

Heart rate measures will be taken during each exercise. Higher values = higher exertion of each exercise performed. 50 beats per min - 120 = low, 120- 150 beats per min = moderate and 150 beats per min = high.

Bertec Force plate posturography

时间窗: through study completion, an average of 1 year

Centre of pressure displacement and velocity parameters will be measured using a Bertec force plate and Pro-Vec software. Measurements include the position traces of anterior-posterior and mediolateral centre of pressure to provide feedback of postural stability. In particular, the mean displacement, root-mean-squared distance from mean, root-mean-square-velocity and the mean velocity of centre of pressure. Participants will stand upright and relaxed in the centre of a portable Bertec force plate with hands on hips and feet touching each other. Data will be collected under 4 different conditions: normal standing with eyes open, normal standing with eyes closed, a tandem stance with eyes open and a tandem stance with eyes closed. This will enable the proprioception and vestibular system to be assessed. Postural sway will be measured in the anteroposterior and mediolateral directions.

Rate of perceived exertion (RPE)

时间窗: 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.

次要结局

  • Balance Confidence Questionnaire (CONFbal)(through study completion, an average of 1 year)
  • Mini Balance Evaluation Test (MINI-BESTest)(through study completeion, an average of 1 year)
  • Short Falls efficacy scale (FES 1)(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nichola Davis

Principal Investigator: Miss Nichola Michelle Davis (PhD Student)

University of Derby

研究点 (4)

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