KARE: Keeping Active in Residential Elderly

• Sponsor: University of Birmingham (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03141879
• Collaborator: HUR Labs (Other), European Commission (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 12

Study Details

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 ).

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly Syndrome; Frailty; Physical Activity	Other: HUR equipment resistance training intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Aug 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Feasibility [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) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

2. Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

3. Serum cortisol: DHEAS ratio (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

4. C-Reactive proteins (CRP) (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

5. Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

6. Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

7. Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

8. Handgrip strenght (Functional Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

9. Leg Strength (Functional Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

10. Leg power output (Functional Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

11. Short Physical Performance Battery (SPPB) (Functional Dependent Variable) [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) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

13. Fried Frailty Phenotype (Functional Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

14. Geriatric Depression Scale (GDS) (Psychological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

15. Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

16. Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

17. Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable) [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) [Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom	Birmingham	West Midlands	United Kingdom

Sponsors and Collaborators

• University of Birmingham
• HUR Labs
• European Commission

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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.

• Responsible Party: University of Birmingham
• ClinicalTrials.gov Identifier: NCT03141879
• Other Study ID Numbers: ERN_16-1438
• First Posted: May 5, 2017
• Last Update Posted: Mar 13, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Frailty

Study Results

No Results Posted as of Mar 13, 2019