Keeping Active in Residential Elderly

Physical Activity Clinical Trial

— KARE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03141879
• Other study ID #: ERN_16-1438
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: August 2019

Study information

• Verified date: March 2019
• Source: University of Birmingham
• Contact: Mr. Paul Doody
• Phone: +44 (0) 121 414
• Email: p.d.doody[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Physical Activity

Intervention

Other:
• HUR equipment resistance training intervention
Resistance training intervention

Locations

Country	Name	City	State
United Kingdom	Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	European Commission, HUR Labs

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortisol (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Serum cortisol: DHEAS ratio (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	C-Reactive proteins (CRP) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFa) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Handgrip strenght (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Leg Strength (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Leg power output (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Short Physical Performance Battery (SPPB) (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	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)
Secondary	Fried Frailty Phenotype (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Geriatric Depression Scale (GDS) (Psychological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Secondary	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)
Secondary	Interpersonal Support Evaluation List (Social Dependent Variable)		Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

External Links

•   Physical Activity and Nutritional INfluences In ageing (PANINI) project twitter
•   Physical Activity and Nutritional INfluences In ageing (PANINI) project website