Assessing the Feasibility and Impact of an Adapted Resistance Training Intervention, Aimed at Improving the Multi-dimensional Health and Functional Capacity of Frail Older Adults in Residential Care Settings: Protocol for a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
This trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. This proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity intervention, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a residential care setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place at the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Residents within the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
- •≥ 65 years of age
- •Frail according to the Fried Frailty criteria: meeting at least three of the five characteristics of frailty (Fried et al. 2001)
- •Have the capacity to speak and read in English
排除标准
- •Currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study
- •Currently terminally ill with life expectancy which is less than the duration of the follow-up of the study
- •Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.
研究组 & 干预措施
Regular care
(Wait-list control)
Physical Activity Intervention
HUR resistance training intervention
干预措施: HUR equipment resistance training intervention (Other)
结局指标
主要结局
Feasibility
时间窗: Feasibility assessments will occur post-intervention (six-weeks) and during the follow-up (12-weeks), assessing the feasibility of the study from baseline to follow up (12 weeks)
The primary dependent variables of this feasibility study will relate to the eight primary areas of focus of feasibility studies (Bowen et al. 2009), relating to: * Acceptability * Demand * Implementation * Practicality * Adaptation * Integration * Expansion and * Limited-efficacy testing These eight aforementioned areas (all constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of the proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with study participants post intervention, while focus groups will be utilised with both the intervention implementers and study support staff in order to assess the primary dependent variable of the study.
次要结局
- Cortisol (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Fried Frailty Phenotype (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Short Physical Performance Battery (SPPB) (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Leg power output (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Serum cortisol: DHEAS ratio (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- C-Reactive proteins (CRP) (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Handgrip strenght (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Leg Strength (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Interpersonal Support Evaluation List (Social Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))
- Geriatric Depression Scale (GDS) (Psychological Dependent Variable)(Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks))