Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447948
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-13
Brief Title:
Keep Exercising Stay Steady Development and Feasibility of a Digital Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End
Sponsor:
Northumbria University
Organization:
Northumbria University
Study Overview
Official Title:
Keep Exercising Stay Steady KESS Development and Feasibility of a Digital Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KESS
Brief Summary:
Falls and broken bones are a common health problem faced by older adults Worldwide one third of adults aged over 65 years old and half of adults aged over 80 years fall each year One in five falls in older adults result in hospitalisation and one in twenty cause broken bones Each year 300000 older adults break a bone following a fall which costs the UK 44billion in healthcare costs Broken hip bones are the most serious outcome of a fall One in twenty older adults will die and one in five need care assisted living following a hip fracture
Muscles and bones become weaker after 50 years of age which increases an older adults risk of falling and breaking a bone Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults However many older adults stop doing exercise and become less physically active after falls prevention programmes end Gains in balance and muscle strength are lost and falls risk increase if people dont keep exercising More people are reaching older ages and becoming less active Therefore this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults
The research ambition is to create a technology supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end This will help to prevent future falls and broken bones which will allow more older adults to continue living independently The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling
Older people at risk of falls clinicians and public members will be invited to form a research advisory group The group will work with the research team to create the home exercise programme and research plan and advise how best to communicate the research to the public Diversity within the research advisory group will be important to help shape the research to meet the diverse views and needs of the many different people affected by falls and broken bones We will target the research to help older adults with the greatest health needs Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most
Muscles and bones become weaker after 50 years of age which increases an older adults risk of falling and breaking a bone Falls prevention programmes that include muscle strength and balance exercise improves physical function and helps to prevent falls and broken bones in older adults However many older adults stop doing exercise and become less physically active after falls prevention programmes end Gains in balance and muscle strength are lost and falls risk increase if people dont keep exercising More people are reaching older ages and becoming less active Therefore this problem will worsen unless healthcare practices become better at preventing falls and broken bones in older adults
The research ambition is to create a technology supported home exercise programme that encourages older adults to keep exercising after falls prevention programmes end This will help to prevent future falls and broken bones which will allow more older adults to continue living independently The home exercise programme will benefit older adults everyday lives by helping them to maintain good physical health and improve their ability to perform daily tasks without the fear of falling
Older people at risk of falls clinicians and public members will be invited to form a research advisory group The group will work with the research team to create the home exercise programme and research plan and advise how best to communicate the research to the public Diversity within the research advisory group will be important to help shape the research to meet the diverse views and needs of the many different people affected by falls and broken bones We will target the research to help older adults with the greatest health needs Older adults living in deprived neighbourhoods have the greatest risk of falling and dying following a broken bone The home exercise programme will be researched in older adults attending falls prevention programmes in the most deprived regions of England This will help us to explore whether the programme could encourage the continuation of exercise in older adults who need it most
Detailed Description:
PURPOSE
Age-related declines in muscle strength and balance are key risk factors for falls and severe injury in older adults Completion of group-based Falls Management Exercise FaME programmes significantly improves muscle strength and balance functional status and reduces falls incidence and injurious falls in older adults Significant reductions in falls incidence are sustained for up to 2 years in people who maintain increases in their physical activity PA levels after FaME programmes end IRR049 95 CI 030 079 p0004 The proportion of people considered as being physically active is 54 upon exiting FaME programmes However these proportions decrease to between 40 to 49 six to eighteen months after FaME programmes end
Over time improvements in strength balance and physical function are lost and falls incidence increase if people do not remain active after programmes end Home-based exercise delivered via digital means is effective at improving strength balance and functional status and significantly reduces falls incidence in older adults This research aims is to develop and investigate the feasibility and acceptability of a digitally supported exercise maintenance intervention that includes an NHS Approved Falls Prevention App Keep on Keep Up KOKU App and PA monitoring tools to people exiting FaME programmes
STUDY AIM To design and investigate the feasibility acceptability and safety of a digitally supported exercise maintenance intervention to Falls Management Exercise FaME programme service-users
STUDY OBJECTIVES
1 Co-design a digitally supported exercise maintenance intervention with a Community of Practice Group COPG and Patient and Public Involvement PPI group
2 Investigate the acceptability of the digitally supported exercise maintenance intervention to FaME programme service-users
3 Assess the feasibility of the research methods and key parameters needed to conduct future clinical trials
STUDY DESIGN The project will be conducted in two separate phases as interdependency exists between the research objectives
Phase 1 Intervention Development Acceptability Study
Phase 2 Feasibility Study
METHODS
Phase 1 Intervention development and Acceptability Study
Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability1 2 In consultations the investigators will work with a group of diverse PPI members and key stakeholders to define a digitally supported exercise maintenance intervention and procedures Digital intervention components may include self-monitoring physical activity PA via wearables digital peer support and home exercise delivered via an evidence-based Falls Prevention App KOKU App
To explore early intervention acceptability n10 FaME class users will be invited to test the exercise maintenance intervention for 1 month Intervention acceptability feedback will be collected via technology acceptance questionnaires4 5 analysed and triangulated into a report
After initial testing the research participants will be invited to attend a COPG workshop containing researchers PPI members and service providers to provide further qualitative feedback regarding the interventions acceptability During the workshop the collective group will use the participants feedback and the information in the report to optimise the intervention for progression into phase 2 Workshops will be audio-recorded transcribed and analysed thematically
Phase 2 Feasibility Study
A mixed methods single-arm multi-site feasibility study will be conducted to investigate the feasibility acceptability and safety of the exercise maintenance intervention optimised in phase 1 and the feasibility of the research methods
The investigators will recruit and deliver the exercise maintenance intervention for up to 6 months in 30 FaME class attendees
Feasibility data will be collected and measured over 6 months via
Recruitment and retention rates
Feasibility of collecting self-reported quality of life falls incidence and confidence data via the Falls Prevention App
Adverse event data
Intervention adherence will be ascertained via i frequency and duration of technology use and exercise progressions ii Weekly minutes of MVPA and strength and balance exercise minutes
A priori progression criteria will be set on feasibility outcomes to determine future progression to a larger-scale clinical trial The progression criteria for a full-scale trial will be as follows 70 of targeted number of participants are recruited within a 6-month window 50 of recruited participants complete the study and provide outcome data at follow up evidence that participants have maintained an improvement in falls risk factors 10 of any serious adverse effects deemed to be due to the intervention
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n20 participants Semi-structured interviews will be conducted by a researcher in the participants preferred venue or online Interviews will be audio recorded transcribed and handled using NVIVO10-software Two researchers will code the transcripts via framework analysis
Participant data is routinely collected by the HealthWorks Charity for service purposes Under information sharing agreements the following routine data will be shared with the researchers Age gender ethnicity postcodeIMD height body weight medical history medication falls history functional ability ie 30-s chair stand Timed-Up-and-Go balance measures ie four-stage balance test
Routine data will be collected at three time-points T1-before FaME T2-after FaME T3-after the maintenance intervention and will be analysed and reported via descriptive statistics
SAMPLE SETTING The investigators are working in collaboration with the HealthWorks Charity that delivers FaME classes to people living in deprived areas of Newcastle Upon Tyne England To ensure people experiencing health inequalities are represented in the study the investigators will recruit a sample of older adults from four HealthWorks Charity hubs and deliver the intervention in these venues
Age-related declines in muscle strength and balance are key risk factors for falls and severe injury in older adults Completion of group-based Falls Management Exercise FaME programmes significantly improves muscle strength and balance functional status and reduces falls incidence and injurious falls in older adults Significant reductions in falls incidence are sustained for up to 2 years in people who maintain increases in their physical activity PA levels after FaME programmes end IRR049 95 CI 030 079 p0004 The proportion of people considered as being physically active is 54 upon exiting FaME programmes However these proportions decrease to between 40 to 49 six to eighteen months after FaME programmes end
Over time improvements in strength balance and physical function are lost and falls incidence increase if people do not remain active after programmes end Home-based exercise delivered via digital means is effective at improving strength balance and functional status and significantly reduces falls incidence in older adults This research aims is to develop and investigate the feasibility and acceptability of a digitally supported exercise maintenance intervention that includes an NHS Approved Falls Prevention App Keep on Keep Up KOKU App and PA monitoring tools to people exiting FaME programmes
STUDY AIM To design and investigate the feasibility acceptability and safety of a digitally supported exercise maintenance intervention to Falls Management Exercise FaME programme service-users
STUDY OBJECTIVES
1 Co-design a digitally supported exercise maintenance intervention with a Community of Practice Group COPG and Patient and Public Involvement PPI group
2 Investigate the acceptability of the digitally supported exercise maintenance intervention to FaME programme service-users
3 Assess the feasibility of the research methods and key parameters needed to conduct future clinical trials
STUDY DESIGN The project will be conducted in two separate phases as interdependency exists between the research objectives
Phase 1 Intervention Development Acceptability Study
Phase 2 Feasibility Study
METHODS
Phase 1 Intervention development and Acceptability Study
Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability1 2 In consultations the investigators will work with a group of diverse PPI members and key stakeholders to define a digitally supported exercise maintenance intervention and procedures Digital intervention components may include self-monitoring physical activity PA via wearables digital peer support and home exercise delivered via an evidence-based Falls Prevention App KOKU App
To explore early intervention acceptability n10 FaME class users will be invited to test the exercise maintenance intervention for 1 month Intervention acceptability feedback will be collected via technology acceptance questionnaires4 5 analysed and triangulated into a report
After initial testing the research participants will be invited to attend a COPG workshop containing researchers PPI members and service providers to provide further qualitative feedback regarding the interventions acceptability During the workshop the collective group will use the participants feedback and the information in the report to optimise the intervention for progression into phase 2 Workshops will be audio-recorded transcribed and analysed thematically
Phase 2 Feasibility Study
A mixed methods single-arm multi-site feasibility study will be conducted to investigate the feasibility acceptability and safety of the exercise maintenance intervention optimised in phase 1 and the feasibility of the research methods
The investigators will recruit and deliver the exercise maintenance intervention for up to 6 months in 30 FaME class attendees
Feasibility data will be collected and measured over 6 months via
Recruitment and retention rates
Feasibility of collecting self-reported quality of life falls incidence and confidence data via the Falls Prevention App
Adverse event data
Intervention adherence will be ascertained via i frequency and duration of technology use and exercise progressions ii Weekly minutes of MVPA and strength and balance exercise minutes
A priori progression criteria will be set on feasibility outcomes to determine future progression to a larger-scale clinical trial The progression criteria for a full-scale trial will be as follows 70 of targeted number of participants are recruited within a 6-month window 50 of recruited participants complete the study and provide outcome data at follow up evidence that participants have maintained an improvement in falls risk factors 10 of any serious adverse effects deemed to be due to the intervention
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n20 participants Semi-structured interviews will be conducted by a researcher in the participants preferred venue or online Interviews will be audio recorded transcribed and handled using NVIVO10-software Two researchers will code the transcripts via framework analysis
Participant data is routinely collected by the HealthWorks Charity for service purposes Under information sharing agreements the following routine data will be shared with the researchers Age gender ethnicity postcodeIMD height body weight medical history medication falls history functional ability ie 30-s chair stand Timed-Up-and-Go balance measures ie four-stage balance test
Routine data will be collected at three time-points T1-before FaME T2-after FaME T3-after the maintenance intervention and will be analysed and reported via descriptive statistics
SAMPLE SETTING The investigators are working in collaboration with the HealthWorks Charity that delivers FaME classes to people living in deprived areas of Newcastle Upon Tyne England To ensure people experiencing health inequalities are represented in the study the investigators will recruit a sample of older adults from four HealthWorks Charity hubs and deliver the intervention in these venues
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None