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Keeping Active in Residential Elderly (KARE)

Primary Purpose

Frail Elderly Syndrome, Frailty, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HUR equipment resistance training intervention
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Elderly Syndrome focused on measuring Frailty, Physical Activity, Resistance training

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity Intervention

Regular care

Arm Description

HUR resistance training intervention

(Wait-list control)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cortisol (Physiological Dependent Variable)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
C-Reactive proteins (CRP) (Physiological Dependent Variable)
Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Handgrip strenght (Functional Dependent Variable)
Leg Strength (Functional Dependent Variable)
Leg power output (Functional Dependent Variable)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Fried Frailty Phenotype (Functional Dependent Variable)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Standardized Mini-Mental State Examination (SMMSE)
Interpersonal Support Evaluation List (Social Dependent Variable)

Full Information

First Posted
April 21, 2017
Last Updated
March 11, 2019
Sponsor
University of Birmingham
Collaborators
HUR Labs, European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03141879
Brief Title
Keeping Active in Residential Elderly
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
HUR Labs, European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Frailty, Physical Activity
Keywords
Frailty, Physical Activity, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity Intervention
Arm Type
Experimental
Arm Description
HUR resistance training intervention
Arm Title
Regular care
Arm Type
No Intervention
Arm Description
(Wait-list control)
Intervention Type
Other
Intervention Name(s)
HUR equipment resistance training intervention
Intervention Description
Resistance training intervention
Primary Outcome Measure Information:
Title
Feasibility
Description
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)
Secondary Outcome Measure Information:
Title
Cortisol (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
C-Reactive proteins (CRP) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Handgrip strenght (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Leg Strength (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Leg power output (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
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)
Title
Fried Frailty Phenotype (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Description
Standardized Mini-Mental State Examination (SMMSE)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Title
Interpersonal Support Evaluation List (Social Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Paul Doody
Phone
+44 (0) 121 414
Ext
4125
Email
p.d.doody@bham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Anna Whittaker
Phone
+44 (0) 121 414
Ext
4398
Email
a.c.whittaker@bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Anna Whittaker
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Pitt-Francis

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
19362699
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.
Results Reference
background
PubMed Identifier
34510020
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.
Results Reference
derived
PubMed Identifier
31321070
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.
Results Reference
derived
Links:
URL
http://www.birmingham.ac.uk/generic/panini/index.aspx
Description
Physical Activity and Nutritional INfluences In ageing (PANINI) project website
URL
https://twitter.com/PANINI_EU
Description
Physical Activity and Nutritional INfluences In ageing (PANINI) project twitter

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Keeping Active in Residential Elderly

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