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 (IRR=0.49, 95% CI 0.30, 0.79; p=0.004). 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 Acceptability\[1, 2\]. 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, n=10 FaME class users will be invited to test the exercise maintenance intervention for 1 month. Intervention acceptability feedback will be collected via technology acceptance questionnaires\[4, 5\], 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 n=20 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, postcode/IMD, height, body weight, medical history, medication, falls history, functional ability (i.e. 30-s chair stand, Timed-Up-and-Go), balance measures (i.e. 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.
