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Seated Physical Activity in Ageing (SPAA)

Primary Purpose

Frail Elderly Syndrome, Frailty, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Intervention 1: Move It Or Lose It (MIOLI)
Exercise Intervention 2: Machine-based resistance training intervention
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frail Elderly Syndrome

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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 study's interventions
  • Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.

Sites / Locations

  • Harborne Ward, Queen Elizabeth Hospital BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise Intervention 1: Move It Or Lose It (MIOLI)

Exercise Intervention 2: Machine-based resistance training

Arm Description

An established chair-based physical activity programme for older adults.

Specialised, chair-based resistance training equipment for older adults.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cortisol (Physiological Dependent Variable)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
C-reactive proteins (CRP) (Physiological Dependent Variable)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Hand grip strength (Functional Dependent Variable)
Leg strength (Functional Dependent Variable)
Leg power output (Functional Dependent Variable)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Fried Frailty Phenotype (Functional Dependent Variable)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)

Full Information

First Posted
April 21, 2017
Last Updated
July 25, 2019
Sponsor
University of Birmingham
Collaborators
The Queen Elizabeth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03141866
Brief Title
Seated Physical Activity in Ageing
Acronym
SPAA
Official Title
"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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
August 9, 2019 (Anticipated)
Study Completion Date
August 9, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
The Queen Elizabeth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Frailty, Physical Activity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention 1: Move It Or Lose It (MIOLI)
Arm Type
Experimental
Arm Description
An established chair-based physical activity programme for older adults.
Arm Title
Exercise Intervention 2: Machine-based resistance training
Arm Type
Experimental
Arm Description
Specialised, chair-based resistance training equipment for older adults.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention 1: Move It Or Lose It (MIOLI)
Intervention Description
An established chair-based physical activity programme for older adults.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention 2: Machine-based resistance training intervention
Intervention Description
Specialised, chair-based, pneumatic resistance training equipment for older adults.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
Post-Intervention (2 weeks)
Secondary Outcome Measure Information:
Title
Cortisol (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
C-reactive proteins (CRP) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Hand grip strength (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Leg strength (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Leg power output (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Fried Frailty Phenotype (Functional Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)
Title
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)
Time Frame
Pre-intervention (baseline), and post-intervention (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 study's interventions Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Paul Doody
Phone
+44 (0) 121 414
Ext
4125
Email
p.d.doody@bham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Anna Whittaker
Phone
+44 (0) 121 414
Ext
4398
Email
a.c.whittaker@bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Anna Whittaker
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborne Ward, Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Zoe Wyrko
Email
zoe.wyrko@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dr. Thomas Jackson
Email
t.jackson@bham.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
19362699
Citation
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.
Results Reference
background
PubMed Identifier
31753876
Citation
Doody 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.
Results Reference
derived
Links:
URL
http://www.birmingham.ac.uk/generic/panini/index.aspx
Description
Physical Activity and Nutritional INfluences In ageing (PANINI) project website
URL
https://twitter.com/PANINI_EU
Description
Physical Activity and Nutritional INfluences In ageing (PANINI) project twitter

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Seated Physical Activity in Ageing

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