跳至主要内容
临床试验/NCT05758727
NCT05758727已完成不适用

The Efficacy of Home-based Strength and Tai-chi Exercise Snacking for Improving Physical Function in Taiwanese and British Older Adults: a Randomised Control Trial.

University of Bath1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年5月20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
90
试验地点
1
主要终点
Changes of Short Physical Performance Battery (SPPB) between every 4 weeks

研究概览

简要总结

Engaging in muscle strength and balance (S&B) exercises and has numerous health benefits for older adults, promoting greater mobility, reducing risk of falling, and overall improved health and wellbeing. Given the rising age of global populations, reducing the burden associated with lost physical function is essential to minimise health and social care costs. Unfortunately, very few older adults engage in sufficient S&B exercise to reap these benefits, with a lack of time, self-efficacy and access to leisure facilities cited as the key barriers. Finding innovative ways promote an acceptable and engaging format of S&B exercise is consequently a public health priority.

One novel way that aims to address typical barriers to participation in older adults is through the promotion of exercise 'snacks', as opposed to a more traditional, lengthy structured exercise session at a leisure centre. Exercise snacking describes short bursts of exercise that are designed to be undertaken over a short period in the home environment and without the need for any specialised exercise clothing or equipment. In the initial laboratory and cross-sectional and pilot intervention research, the investigators have been testing two formats of 5-minute, twice-daily, strength exercise- and tai-chi-snacking, which has been shown to be acceptable and feasible to implement in older adults. This protocol presents initial efficacy for evoking improved physical function in people aged 65 years or more. The investigators' remote study demonstrated that remote assessment and delivery of 4-week exercise and tai-chi snacking interventions were acceptable and feasible. However, qualitative feedback indicated that exercise programmes may be more acceptable and interesting with simpler tai-chi movements and exercise snacking programme with upper body movements. Nevertheless, the investigators only recruited healthy older adults, doing short-term interventions in previous studies. This study aims to test the effectiveness of progressive S&B interventions over a sustained period in pre-frail older adults.

详细描述

This study will take place over approximately 3 months and involve 5 assessments remotely. A subset of 60 participants will be assessed in person to validate the remote assessment and undergo more in-depth assessments.

Assessment 1: Familiarisation Participants will be directed to a web page with the participant information sheet and a consent tick box. Participants will then complete an online screening questionnaire that will assess eligibility. After this, participants will undertake a familiarisation session either online (all participants) or in person (lab participants only) to become accustomed to the physical function tests and undergo an exercise safety assessment.

Assessment 2: Baseline assessment. After familiarisation, eligible participants will then complete an online baseline questionnaire assessing demographic details, physical activity levels and psychological outcomes. A functional assessment will be arranged over video calling software, and in the laboratory for the lab participants. Functional outcomes will be completed at this visit. Following the baseline assessment participants will be randomised to either the intervention group, or the waitlist control group.

Assessment 3 and 4: Mid intervention. Participants in the intervention group will be given an exercise teaching video and written instructions on how to safely perform the exercise at home by email. The intervention will take place over 12 weeks and consists of three progressive phases that will be self-selected by participants. The participants will be asked to do the exercises and progress to the next level if they pass the progress criteria which will be clearly explained in the exercise guides and instructional videos. The participants will also be asked to record self-reported exercise logs and RPE for each session they complete. Participants will undergo follow-up assessments at weeks 4 and 8 through video calls and in person (if in the lab study).

Assessment 5: Follow-up assessment. After 12 weeks, participants will complete another online survey containing all psychosocial variables and an evaluation of the usefulness and acceptability of their assigned exercise activities. Participants will also undergo follow-up physical performance tests through video calls and in person (if in the lab study) and a subset will undergo a qualitative evaluation to provide further feedback on the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People aged 65 or greater and are able to perform daily physical activity independently.
  • •Not regularly engaging in recreational sports or structured exercise (once a week or more).
  • •Citizen of UK or Taiwan.
  • •Individuals who are able to do the 5 reps sit-to-stand in less than 60s and the feet side-by-side stand for at least 10s, following the initial safety screening.

排除标准

  • •Individuals with current ongoing medication or treatment for injuries or illness that would impact on any of the study outcomes.
  • •Individuals with a current musculoskeletal injury that would preclude participation in exercise ascertained through preliminary screening.
  • •Individuals with contraindications to exercise including chest pain, dizziness, or loss of consciousness, or who have been instructed by their doctor to only do physical activity recommended by them.
  • •Individuals who have been diagnosed with dementia.
  • •Individuals who are unable to consent for themselves or complete the familiarisation / baseline screening by themselves.
  • •Individuals who score more than 8 on the Short Physical Performance Battery, score more than 6 between strength and balance sections, or score zero on any component of the test.

研究组 & 干预措施

Home-based exercise group

Experimental

This group will be asked to practise the 'exercise snacking and Tai-chi snacking' exercises once each and record the exercise bouts in a log book.

干预措施: Exercise intervention (Other)

Control group

No Intervention

Usual care control group

结局指标

主要结局

Changes of Short Physical Performance Battery (SPPB) between every 4 weeks

时间窗: 12-weeks (week 0, week 4, week 8, week 12)

Participants will be asked to do the SPPB test which includes balance test, gait speed test, and chair stand test.

次要结局

  • Balance function(12-weeks (week 0, week 4, week 8, week 12))
  • Self-confidence for exercise: Self-Efficacy for Exercise (SEE) Scale(12-weeks (week 0, week 4, week 8, week 12))
  • Attitudes to exercise: the Behaviour Regulation Exercise Questionnaire (BREQ-3)(12-weeks (week 0, week 4, week 8, week 12))
  • 1RM of leg press(12-weeks (week 0, week 4, week 8, week 12))
  • Self-confidence for exercise: Perceived Competence for Exercise Scale(12-weeks (week 0, week 4, week 8, week 12))
  • Attitudes to exercise: Multidimensional Outcome Expectations for Exercise Scale (MOEES)(12-weeks (week 0, week 4, week 8, week 12))
  • Attitudes to exercise: the Self-Report Habit Index(12-weeks (week 0, week 4, week 8, week 12))
  • Flexibility(12-weeks (week 0, week 4, week 8, week 12))
  • Current mental health: Subjective Vitality Index(12-weeks (week 0, week 4, week 8, week 12))
  • Acceptability of the intervention: Theoretical framework of acceptability questionnaire(12-weeks (week 4, week 8, week 12))
  • Mental health and wellbeing: the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS)(12-weeks (week 0, week 4, week 8, week 12))
  • Agility function(12-weeks (week 0, week 4, week 8, week 12))
  • Physical activity level: the instrumental activities of daily living (IADL)(12-weeks (week 0, week 4, week 8, week 12))
  • Physical activity level: the International Physical Activity Questionnaire for elderly (IPAQ-E) (short form)(12-weeks (week 0, week 4, week 8, week 12))
  • General health: Short Form Health Survey (SF-36)(12-weeks (week 0, week 4, week 8, week 12))
  • Strength function(12-weeks (week 0, week 4, week 8, week 12))
  • Quality of life and wellbeing: Life Satisfaction Scale(12-weeks (week 0, week 4, week 8, week 12))
  • Quality of life: EQ-5D-5L(12-weeks (week 0, week 4, week 8, week 12))

研究者

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

Ian-Ju Liang

Doctoral student

University of Bath

研究点 (1)

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