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Keeping Active in Residential Elderly (KARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141879
Recruitment Status : Not yet recruiting
First Posted : May 5, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
HUR Labs
European Commission
Information provided by (Responsible Party):
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 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 ).

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Frailty Physical Activity Other: HUR equipment resistance training intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Physical Activity Intervention
HUR resistance training intervention
Other: HUR equipment resistance training intervention
Resistance training intervention

No Intervention: Regular care
(Wait-list control)



Primary Outcome Measures :
  1. Feasibility [ 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) ]

    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 :
  1. Cortisol (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  2. Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  3. Serum cortisol: DHEAS ratio (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  4. C-Reactive proteins (CRP) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  5. Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  6. Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  7. Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  8. Handgrip strenght (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  9. Leg Strength (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  10. Leg power output (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  11. Short Physical Performance Battery (SPPB) (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  12. 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) ]
  13. Fried Frailty Phenotype (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  14. Geriatric Depression Scale (GDS) (Psychological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  15. Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  16. Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
  17. Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]
    Standardized Mini-Mental State Examination (SMMSE)

  18. Interpersonal Support Evaluation List (Social Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141879


Contacts
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Contact: Mr. Paul Doody +44 (0) 121 414 ext 4125 p.d.doody@bham.ac.uk
Contact: Prof. Anna Whittaker +44 (0) 121 414 ext 4398 a.c.whittaker@bham.ac.uk

Locations
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United Kingdom
Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
Birmingham, West Midlands, United Kingdom
Contact: Emily Pitt-Francis         
Sponsors and Collaborators
University of Birmingham
HUR Labs
European Commission
Investigators
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Principal Investigator: Prof. Anna Whittaker University of Birmingham

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03141879    
Other Study ID Numbers: ERN_16-1438
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
Frailty
Physical Activity
Resistance training
Additional relevant MeSH terms:
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Frailty
Pathologic Processes