Seated Physical Activity in Ageing

Physical Activity Clinical Trial

— 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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03141866
• Other study ID #: ERN_16-0986S
• Secondary ID: 675003
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: April 2019
• Source: University of Birmingham
• Contact: Mr. Paul Doody
• Phone: +44 (0) 121 414
• Email: p.d.doody[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Physical Activity

Intervention

Other:
• Exercise Intervention 1: Move It Or Lose It (MIOLI)
An established chair-based physical activity programme for older adults.
• Exercise Intervention 2: Machine-based resistance training intervention
Specialised, chair-based, pneumatic resistance training equipment for older adults.

Locations

Country	Name	City	State
United Kingdom	Harborne Ward, Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Queen Elizabeth Hospital Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortisol (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Serum cortisol : DHEAS ratio (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	C-reactive proteins (CRP) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFa) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Hand grip strength (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Leg strength (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Leg power output (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Short Physical Performance Battery (SPPB) (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Fried Frailty Phenotype (Functional Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Geriatric Depression Scale (GDS) (Psychological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)
Secondary	Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)		Pre-intervention (baseline), and post-intervention (2 weeks)

External Links

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