Keeping Active in Residential Elderly

Study Overview
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Brief Summary
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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 ).

Official Title
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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

Conditions
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Frail Elderly Syndrome, Frailty, Physical Activity

Intervention / Treatment
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* Other: HUR equipment resistance training intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Intervention<br>HUR resistance training intervention | Other: HUR equipment resistance training intervention<br>* Resistance training intervention<br>|
| No Intervention: Regular care<br>(Wait-list control) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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: Interleukin 6 (IL-6) (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) | 
| Inflammatory cytokine: Interferon gamma (IFNy) (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) | 
| Leg power output (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) | 
| 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) | 
| Fried Frailty Phenotype (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) | 
| 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) | Standardized Mini-Mental State Examination (SMMSE) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Physical Activity, Resistance training