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 ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Resistance training intervention
Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
Birmingham, West Midlands, United Kingdom
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.
Time frame: 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)
Cortisol (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
C-Reactive proteins (CRP) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Handgrip strenght (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg Strength (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg power output (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time frame: 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)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
Time frame: 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)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Interpersonal Support Evaluation List (Social Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
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