Seated Physical Activity in Ageing
SPAA
"Determining the Feasibility of Chair-based Physical Activity Interventions, Aimed at Improving Various Aspects of Health and Wellbeing in Geriatric Populations With Pre-existing Frailty, Within a Hospital Ward Setting"
2 other identifiers
interventional
30
1 country
1
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 interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
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
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2019
CompletedJuly 26, 2019
April 1, 2019
11 months
April 21, 2017
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility
The primary dependent variable 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 (constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of a proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with 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. Participant uptake and adherence records will also be employed throughout.
Post-Intervention (2 weeks)
Secondary Outcomes (17)
Cortisol (Physiological Dependent Variable)
Pre-intervention (baseline), and post-intervention (2 weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Pre-intervention (baseline), and post-intervention (2 weeks)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
Pre-intervention (baseline), and post-intervention (2 weeks)
C-reactive proteins (CRP) (Physiological Dependent Variable)
Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Pre-intervention (baseline), and post-intervention (2 weeks)
- +12 more secondary outcomes
Study Arms (2)
Exercise Intervention 1: Move It Or Lose It (MIOLI)
EXPERIMENTALAn established chair-based physical activity programme for older adults.
Exercise Intervention 2: Machine-based resistance training
EXPERIMENTALSpecialised, chair-based resistance training equipment for older adults.
Interventions
An established chair-based physical activity programme for older adults.
Specialised, chair-based, pneumatic resistance training equipment for older adults.
Eligibility Criteria
You may qualify if:
- Temporary residents within the Harborne 'living lab' ward of the Queen Elizabeth Hospital Birmingham, Edgbaston, 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
- Anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. This will be advised by the patient's care team.
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 study's interventions
- 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
- University of Birminghamlead
- The Queen Elizabeth Hospitalcollaborator
Study Sites (1)
Harborne Ward, Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH, United Kingdom
Related Publications (2)
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: 19362699BACKGROUNDDoody P, Lord JM, Greig CA, Whittaker AC. Assessing the feasibility and impact of specially adapted exercise interventions, aimed at improving the multi-dimensional health and functional capacity of frail geriatric hospital inpatients: protocol for a feasibility study. BMJ Open. 2019 Nov 21;9(11):e031159. doi: 10.1136/bmjopen-2019-031159.
PMID: 31753876DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prof. Anna Whittaker
University of Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2017
First Posted
May 5, 2017
Study Start
September 3, 2018
Primary Completion
August 9, 2019
Study Completion
August 9, 2019
Last Updated
July 26, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share