Clinical trial NCT03141879: Keeping Active in Residential Elderly
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Frailty
Physical Activity
Keywords: Frailty
Physical Activity
Resistance training
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: HUR Labs
name: European Commission
First posted: 2017-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 ).


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: 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 outcomes:
measure: Cortisol (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: C-Reactive proteins (CRP) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Handgrip strenght (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Leg Strength (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Leg power output (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Fried Frailty Phenotype (Functional Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
measure: Interpersonal Support Evaluation List (Social Dependent Variable)
timeFrame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
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: Swales B, Ryde GC, Whittaker AC. A Randomized Controlled Feasibility Trial Evaluating a Resistance Training Intervention With Frail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial. J Aging Phys Act. 2022 Jun 1;30(3):364-388. doi: 10.1123/japa.2021-0130. Epub 2021 Sep 11.
citation: Doody P, Lord JM, Whittaker AC. 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. Pilot Feasibility Stud. 2019 Jul 5;5:86. doi: 10.1186/s40814-019-0470-1. eCollection 2019.