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Trial record 2 of 2 for:    Paul Doody

Seated Physical Activity in Ageing (SPAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141866
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Queen Elizabeth Hospital Birmingham
Information provided by (Responsible Party):
University of Birmingham

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).

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Frailty Physical Activity Other: Exercise Intervention 1: Move It Or Lose It (MIOLI) Other: Exercise Intervention 2: Machine-based resistance training intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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"
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : August 9, 2019
Estimated Study Completion Date : August 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Intervention 1: Move It Or Lose It (MIOLI)
An established chair-based physical activity programme for older adults.
Other: Exercise Intervention 1: Move It Or Lose It (MIOLI)
An established chair-based physical activity programme for older adults.

Experimental: Exercise Intervention 2: Machine-based resistance training
Specialised, chair-based resistance training equipment for older adults.
Other: Exercise Intervention 2: Machine-based resistance training intervention
Specialised, chair-based, pneumatic resistance training equipment for older adults.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: Post-Intervention (2 weeks) ]

    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 :
  1. Cortisol (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  2. Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  3. Serum cortisol : DHEAS ratio (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  4. C-reactive proteins (CRP) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  5. Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  6. Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  7. Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  8. Hand grip strength (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  9. Leg strength (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  10. Leg power output (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  11. Short Physical Performance Battery (SPPB) (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  12. Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  13. Fried Frailty Phenotype (Functional Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  14. Geriatric Depression Scale (GDS) (Psychological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  15. Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  16. Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]
  17. Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable) [ Time Frame: Pre-intervention (baseline), and post-intervention (2 weeks) ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141866


Contacts
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Contact: Mr. Paul Doody +44 (0) 121 414 ext 4125 p.d.doody@bham.ac.uk
Contact: Prof. Anna Whittaker +44 (0) 121 414 ext 4398 a.c.whittaker@bham.ac.uk

Locations
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United Kingdom
Harborne Ward, Queen Elizabeth Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TH
Contact: Dr. Zoe Wyrko       zoe.wyrko@uhb.nhs.uk   
Contact: Dr. Thomas Jackson       t.jackson@bham.ac.uk   
Sponsors and Collaborators
University of Birmingham
Queen Elizabeth Hospital Birmingham
Investigators
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Principal Investigator: Prof. Anna Whittaker University of Birmingham
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03141866    
Other Study ID Numbers: ERN_16-0986S
675003 ( Other Grant/Funding Number: European Commission )
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes