Seated Physical Activity in Ageing

Not Applicable

• Conditions: Frailty; Frail Elderly Syndrome; Physical Activity

• Registration Number: NCT03141866
• Lead Sponsor: University of Birmingham

Brief Summary

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 interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Study Start: 2018-09-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Temporary residents within the Harborne 'living lab' ward of the Queen Elizabeth Hospital Birmingham, Edgbaston, 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
• Anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. This will be advised by the patient's care team.

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 study's interventions
• Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility	Post-Intervention (2 weeks)	The primary dependent variable 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 (constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of a proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with 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. Participant uptake and adherence records will also be employed throughout.

Secondary Outcome Measures

Name	Time	Method
Hand grip strength (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Fried Frailty Phenotype (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Cortisol (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
C-reactive proteins (CRP) (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Leg strength (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Leg power output (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)	Pre-intervention (baseline), and post-intervention (2 weeks)

Trial Locations

Locations (1)

Harborne Ward, Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom