Clinical trial NCT03141866: Seated Physical Activity in Ageing
Official title: "Determining the Feasibility of Chair-based Physical Activity Interventions, Aimed at Improving Various Aspects of Health and Wellbeing in Geriatric Populations With Pre-existing Frailty, Within a Hospital Ward Setting"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Frailty
Physical Activity
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: The Queen Elizabeth Hospital
First posted: 2017-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: Post-Intervention (2 weeks)
Secondary outcomes:
measure: Cortisol (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: C-reactive proteins (CRP) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Hand grip strength (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Leg strength (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Leg power output (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Fried Frailty Phenotype (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
measure: Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (2 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Harborne Ward, Queen Elizabeth Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Prof. Anna Whittaker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
citation: Doody P, Lord JM, Greig CA, Whittaker AC. Assessing the feasibility and impact of specially adapted exercise interventions, aimed at improving the multi-dimensional health and functional capacity of frail geriatric hospital inpatients: protocol for a feasibility study. BMJ Open. 2019 Nov 21;9(11):e031159. doi: 10.1136/bmjopen-2019-031159.