Frail Elderly SyndromeKARENCT03141879
Keeping Active in Residential Elderly
A study testing HUR equipment 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 intervention, 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?
- HUR equipment resistance training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2019to 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
- Residents within the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, 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
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 follow-up of the study
- 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
Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom
Birmingham, West Midlands
Emily Pitt-Francis
About this study
Official title: Assessing the Feasibility and Impact of an Adapted Resistance Training Intervention, Aimed at Improving the Multi-dimensional Health and Functional Capacity of Frail Older Adults in Residential Care Settings: Protocol for a Feasibility Study
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 intervention, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a residential care setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place at the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom ).
- Conditions
- Frail Elderly Syndrome, Frailty, Physical Activity
- Being tested
- HUR equipment resistance training intervention
- Keywords
- Frailty, Physical Activity, Resistance training
- 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.
HUR equipment resistance training interventionOther
Resistance training intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | HUR resistance training intervention Receives: Other: HUR equipment resistance training intervention |
| Regular care | No intervention | (Wait-list control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The primary dependent variables 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 (all constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of the proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with study 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.
Measured: Feasibility assessments will occur post-intervention (six-weeks) and during the follow-up (12-weeks), assessing the feasibility of the study from baseline to follow up (12 weeks)
Secondary outcomes (18)
Cortisol (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
C-Reactive proteins (CRP) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Handgrip strenght (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg Strength (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg power output (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Standardized Mini-Mental State Examination (SMMSE)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Interpersonal Support Evaluation List (Social Dependent Variable)
Measured: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-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 startApr 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- HUR Labs, European Commission
- Responsible party
- Sponsor
- Investigators
- Prof. Anna Whittaker, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141879
- Sponsor's protocol ID
- ERN_16-1438
- Acronym
- KARE
- Status last verified
- Mar 2019
- First submitted
- 21 Apr 2017
- Last updated
- 13 Mar 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 19362699Swales B, Ryde GC, Whittaker AC. A Mixed Methods Feasibility Study of Machine-Based Resistance Training With Prefrail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial II. J Aging Phys Act. 2024 Jan 23;32(2):244-263. doi: 10.1123/japa.2022-0170. Print 2024 Apr 1.
PubMed 38262397Swales B, Ryde GC, Fletcher I, Whittaker AC. The reliability and suitability of strength assessments in frail and pre-frail older adults: recommendations for strength testing in older populations. BMC Geriatr. 2023 Dec 8;23(1):820. doi: 10.1186/s12877-023-04552-3.
PubMed 38066459Swales B, Ryde GC, Whittaker AC. A Randomized Controlled Feasibility Trial Evaluating a Resistance Training Intervention With Frail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial. J Aging Phys Act. 2022 Jun 1;30(3):364-388. doi: 10.1123/japa.2021-0130. Epub 2021 Sep 11.
PubMed 34510020Doody P, Lord JM, Whittaker AC. Assessing the feasibility and impact of an adapted resistance training intervention, aimed at improving the multi-dimensional health and functional capacity of frail older adults in residential care settings: protocol for a feasibility study. Pilot Feasibility Stud. 2019 Jul 5;5:86. doi: 10.1186/s40814-019-0470-1. eCollection 2019.
PubMed 31321070
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Impact of an Adapted Resistance Training Intervention, Aimed at Improving the Multi-dimensional Health and Functional Capacity of Frail Older Adults in Residential Care Settings: Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT03141879
- Acronym / sponsor ID
- KARE / ERN_16-1438
- Conditions
- Frail Elderly Syndrome, Frailty, Physical Activity
- Keywords
- Frailty, Physical Activity, Resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- HUR Labs, European Commission
- Study start
- Apr 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- 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 intervention, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a residential care setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place at the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, Birmingham, United Kingdom ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Other: HUR equipment resistance training interventionHUR resistance training intervention |
| Regular care | No intervention | –(Wait-list control) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Residents within the Olivet Christadelphian care home, 17 Sherbourne Road, Acocks Green, 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
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 follow-up of the study
- 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 |
|---|---|---|
| HUR equipment resistance training interventionResistance training intervention | Other | Physical Activity Intervention |
Primary outcome
Feasibility
Time frame: Feasibility assessments will occur post-intervention (six-weeks) and during the follow-up (12-weeks), assessing the feasibility of the study from baseline to follow up (12 weeks)
The primary dependent variables 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 (all constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of the proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with study 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.
18 secondary outcomes
Cortisol (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Serum cortisol: DHEAS ratio (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
C-Reactive proteins (CRP) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Inflammatory cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Handgrip strenght (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg Strength (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Leg power output (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Short Physical Performance Battery (SPPB) (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Fried Frailty Phenotype (Functional Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Geriatric Depression Scale (GDS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Psychological Dependent Variable: Perceived Stress Scale (PSS) (Psychological Dependent Variable
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Interpersonal Support Evaluation List (Social Dependent Variable)
Time frame: Pre-intervention (baseline), and post-intervention (six-weeks), follow-up (12-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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 38262397Swales B, Ryde GC, Whittaker AC. A Mixed Methods Feasibility Study of Machine-Based Resistance Training With Prefrail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial II. J Aging Phys Act. 2024 Jan 23;32(2):244-263. doi: 10.1123/japa.2022-0170. Print 2024 Apr 1.
- Derived from this study: PubMed 38066459Swales B, Ryde GC, Fletcher I, Whittaker AC. The reliability and suitability of strength assessments in frail and pre-frail older adults: recommendations for strength testing in older populations. BMC Geriatr. 2023 Dec 8;23(1):820. doi: 10.1186/s12877-023-04552-3.
- Derived from this study: PubMed 34510020Swales B, Ryde GC, Whittaker AC. A Randomized Controlled Feasibility Trial Evaluating a Resistance Training Intervention With Frail Older Adults in Residential Care: The Keeping Active in Residential Elderly Trial. J Aging Phys Act. 2022 Jun 1;30(3):364-388. doi: 10.1123/japa.2021-0130. Epub 2021 Sep 11.
- Derived from this study: PubMed 31321070Doody P, Lord JM, Whittaker AC. Assessing the feasibility and impact of an adapted resistance training intervention, aimed at improving the multi-dimensional health and functional capacity of frail older adults in residential care settings: protocol for a feasibility study. Pilot Feasibility Stud. 2019 Jul 5;5:86. doi: 10.1186/s40814-019-0470-1. eCollection 2019.
- 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 HUR equipment 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 4 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 13 Mar 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: Feasibility assessments will occur post-intervention (six-weeks) and during the follow-up (12-weeks), assessing the feasibility of the study from baseline to follow up (12 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 NCT03141879, which also lists 5 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 13 Mar 2019.