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| ID | Type | Description | Link |
|---|---|---|---|
| 675003 | Other Grant/Funding Number | European Commission |
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| Name | Class |
|---|---|
| The Queen Elizabeth Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention 1: Move It Or Lose It (MIOLI) | Experimental | An established chair-based physical activity programme for older adults. |
|
| Exercise Intervention 2: Machine-based resistance training | Experimental | Specialised, chair-based resistance training equipment for older adults. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention 1: Move It Or Lose It (MIOLI) | Other | An established chair-based physical activity programme for older adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mr. Paul Doody | Contact | +44 (0) 121 414 | 4125 | p.d.doody@bham.ac.uk |
| Prof. Anna Whittaker | Contact | +44 (0) 121 414 | 4398 | a.c.whittaker@bham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Anna Whittaker | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborne Ward, Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | West Midlands | B15 2TH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19362699 | Background | 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. | |
| 31753876 | Derived | 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. |
| Label | URL |
|---|---|
| Physical Activity and Nutritional INfluences In ageing (PANINI) project website | View source |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Exercise Intervention 2: Machine-based resistance training intervention | Other | Specialised, chair-based, pneumatic resistance training equipment for older adults. |
|
| 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) |
| Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Hand grip strength (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Leg strength (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Leg power output (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Short Physical Performance Battery (SPPB) (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Fried Frailty Phenotype (Functional Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Geriatric Depression Scale (GDS) (Psychological Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable) | Pre-intervention (baseline), and post-intervention (2 weeks) |
| Physical Activity and Nutritional INfluences In ageing (PANINI) project twitter | View source |