Frail Elderly SyndromeSPAANCT03141866
Seated Physical Activity in Ageing
A study testing Exercise Intervention 1: Move It Or Lose It (MIOLI) and Exercise Intervention 2: Machine-based resistance training intervention in people with Frail Elderly Syndrome and Frailty, run by University of Birmingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Frailty, Physical Activity
- What is being tested?
- Exercise Intervention 1: Move It Or Lose It (MIOLI) and Exercise Intervention 2: Machine-based resistance training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 9 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Harborne Ward, Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Dr. Zoe Wyrko, zoe.wyrko@uhb.nhs.uk
Dr. Thomas Jackson, t.jackson@bham.ac.uk
About this study
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"
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).
- Conditions
- Frail Elderly Syndrome, Frailty, Physical Activity
- Being tested
- Exercise Intervention 1: Move It Or Lose It (MIOLI), Exercise Intervention 2: Machine-based resistance training intervention
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Intervention 1: Move It Or Lose It (MIOLI)Other
An established chair-based physical activity programme for older adults.
Exercise Intervention 2: Machine-based resistance training interventionOther
Specialised, chair-based, pneumatic resistance training equipment for older adults.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention 1: Move It Or Lose It (MIOLI) | Experimental | An established chair-based physical activity programme for older adults. Receives: Other: Exercise Intervention 1: Move It Or Lose It (MIOLI) |
| Exercise Intervention 2: Machine-based resistance training | Experimental | Specialised, chair-based resistance training equipment for older adults. Receives: Other: Exercise Intervention 2: Machine-based resistance training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-Intervention (2 weeks)
Secondary outcomes (17)
Cortisol (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
C-reactive proteins (CRP) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Hand grip strength (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Leg strength (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Leg power output (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start3 Sep 2018
- Primary completion9 Aug 2019 (estimated)
- Study completion9 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Responsible party
- Sponsor
- Investigators
- Prof. Anna Whittaker, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141866
- Sponsor's protocol ID
- ERN_16-0986S
- Other IDs
- 675003
- Acronym
- SPAA
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2017
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 19362699Doody 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.
PubMed 31753876
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03141866
- Acronym / sponsor ID
- SPAA / ERN_16-0986S
- Conditions
- Frail Elderly Syndrome, Frailty, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- The Queen Elizabeth Hospital
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 9 Aug 2019 (estimated)
- Study completion
- 9 Aug 2019 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention 1: Move It Or Lose It (MIOLI) | Experimental | 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 | Experimental | Other: Exercise Intervention 2: Machine-based resistance training interventionSpecialised, chair-based resistance training equipment for older adults. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| Exercise Intervention 2: Machine-based resistance training interventionSpecialised, chair-based, pneumatic resistance training equipment for older adults. | Other | Exercise Intervention 2: Machine-based resistance training |
Primary outcome
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.
17 secondary outcomes
Cortisol (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Serum cortisol : DHEAS ratio (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
C-reactive proteins (CRP) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Hand grip strength (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Leg strength (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Leg power output (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 19362699Bowen 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.
- Derived from this study: PubMed 31753876Doody 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.
- Physical Activity and Nutritional INfluences In ageing (PANINI) project websiteLink provided by the sponsor.
- Physical Activity and Nutritional INfluences In ageing (PANINI) project twitterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Anna Whittaker principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention 1: Move It Or Lose It (MIOLI) and Exercise Intervention 2: Machine-based resistance training intervention in people with Frail Elderly Syndrome and Frailty, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mr. Paul Doody (+44 (0) 121 414 ext. 4125, p.d.doody@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Post-Intervention (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.