Keeping Active in Residential Elderly (KARE)

March 11, 2019 updated by: University of Birmingham

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

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 ).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

European Commission
HUR Labs

Investigators

  • Principal Investigator: Prof. Anna Whittaker, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERN_16-1438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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