NCT03141879

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 ).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

April 21, 2017

Last Update Submit

March 11, 2019

Conditions

Frail Elderly SyndromeFrailtyPhysical Activity

Keywords

FrailtyPhysical ActivityResistance training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Cortisol (Physiological Dependent Variable)

    Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

  • Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)

    Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

  • Serum cortisol: DHEAS ratio (Physiological Dependent Variable)

    Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

  • C-Reactive proteins (CRP) (Physiological Dependent Variable)

    Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

  • Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)

    Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)

  • +13 more secondary outcomes

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

HUR resistance training intervention

Other: HUR equipment resistance training intervention

Regular care

NO INTERVENTION

(Wait-list control)

Interventions

HUR equipment resistance training interventionOTHER

Resistance training intervention

Physical Activity Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Birmingham, West Midlands, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 19362699BACKGROUND

  • Swales B, Ryde GC, Whittaker AC. A Mixed Methods Feasibility Study of Machine-Based Resistance Training With Prefrail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial II. J Aging Phys Act. 2024 Jan 23;32(2):244-263. doi: 10.1123/japa.2022-0170. Print 2024 Apr 1.

    PMID: 38262397DERIVED

  • Swales B, Ryde GC, Fletcher I, Whittaker AC. The reliability and suitability of strength assessments in frail and pre-frail older adults: recommendations for strength testing in older populations. BMC Geriatr. 2023 Dec 8;23(1):820. doi: 10.1186/s12877-023-04552-3.

    PMID: 38066459DERIVED

  • 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.

    PMID: 34510020DERIVED

  • 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.

    PMID: 31321070DERIVED

Related Links

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Prof. Anna Whittaker

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mr. Paul Doody

CONTACT

+44 (0) 121 414p.d.doody@bham.ac.uk

Prof. Anna Whittaker

CONTACT

+44 (0) 121 414a.c.whittaker@bham.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2017

First Posted

May 5, 2017

Study Start

April 1, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Locations

GB(1)