Keep Exercising & Stay Steady: Development and Feasibility of a Health Intervention to Encourage Exercise Maintenance After Fall Prevention Exercise Programmes End.

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. This research aims is to develop and investigate the feasibility and acceptability of a peer 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 an exercise maintenance intervention to Falls Management Exercise (FaME) programme service-users.

STUDY OBJECTIVES:

1. Co-design an exercise maintenance intervention with a Community of Practice Group (COPG). Professional Stakeholders and Patient and Public Involvement (PPI) members. 2. Investigate the acceptability of the 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 * Phase 2. Feasibility Study.

METHODS:

Phase 1. Intervention development

Intervention Development will be informed by the Normalisation Process Theory and Theoretical Framework of Acceptability\[1, 2\]. In a series of consultations, the investigators will work with groups of PPI members and key stakeholders (older adults, service providers, commissioners) to define an exercise maintenance intervention and procedures.

Consultations will be audio-recorded, transcribed, and analysed thematically to support the development of the exercise maintenance.

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 and the feasibility of the research methods.

The investigators will recruit and deliver the exercise maintenance intervention for up to 8 months in 30 FaME class attendees.

Feasibility data will be collected and measured over 8 months via:

* Recruitment and retention rates. * Adverse event data * Intervention adherence will be ascertained via PASE scores measuring physical activity and strength and balance exercise.

* Intervention acceptability will be examined via a tailored Health Intervention Acceptability Questionairre based on the Theoretical Framework of Acceptability

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, 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 on functional ability 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.

• Recruitment rates (phase 2) [Срок оценки: after 8 month]
• Retention rates (phase 2) [Срок оценки: during and after 8 month of using the KESS intervention]
• Adverse event data (Phase 2) [Срок оценки: during the 6 month intervention period after the inital falls prevention programme ends]
• Semi-structured interviews regarding KESS Acceptability [Срок оценки: after the 8 month intervention period.]