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

ConditionFall Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorNorthumbria University

About this trial

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, 300,000 older adults break a bone following a fall which costs the UK £4.4billion 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 don't 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Community dwelling older adults, aged over 60 years old.

Enrolled on a Healthworks FaME programme in the Northeast region of England.

Able to provide informed written consent.

Disqualifiers

Unable to independently walk 5 metres without a walking aid.

Advised by a medic not to undertake exercise.

Has a medical, cognitive, or physical condition that prevents safe engagement with digital technology or unsupervised exercise.

Trial design

Design model

Single group

Treatments tested in this trial

  • Keep Exercising and Stay Steady

    Behavioral

    Digital Health, home exercise intervention containing a digital NHS approved falls prevention exercise App (Keep On Keep Up), fitness watches, telephone and/or social media communication, and behavior change techniques. Currently (date, 13 May 2024) the intervention has not been developed with the community of practice group. Further details of the phase 1 and phase 2 interventions will be provided after the community of practice events.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seniors Technology Acceptance questionnaire (STAM) (phase 1)

Acceptability feedback on the digital health components will be collected via the Seniors Technology Acceptance questionnaire. The questionnaire contains 14 questions and statements and asks the respondent to rate their response using a 1 to 10 sliding scale (i.e. 1=strongly disagree- 10= strongly agree).

Time frame
after 1 month of using the KESS intervention
2

Health Intervention Acceptability Questionnaire (phase 1)

KESS intervention acceptability feedback will be collected via Health Intervention Acceptability Questionnaire. The questionnaire contains 14 questions and statements and asks respondents to rate their responses using a 1 to 5 sliding scale (i.e. 1= completely unacceptable - 5 = completely acceptable).

Time frame
after 1 month of using the KESS intervention
3

Physical Activity Scale for the Elderly questionnaire (PASE)

Intervention adherence will be ascertained via weekly minutes of moderate to vigorous physical activity and strength and balance exercise. The PASE questionnaire asks respondentss to provide information on the amount of physical activity they have performed for leisure, household chores and work / occupational tasks in the past 7 days.

Time frame
after 6 month of using the KESS intervention

Secondary outcomes

1

Frequency and duration of KOKU App use (Phase 2)

Intervention adherence will be ascertained via the frequency (no of times per week) and duration (weekly number of minutes) of technology use the is collected via KOKU App metrics.

Time frame
after 6 month of using the KESS intervention
2

Recruitment rates (phase 2)

Recruitment rates will be recorded as the number of participants invited and the percentage consenting to enter the feasibility study.

Time frame
after 6 month
3

Retention rates (phase 2)

Retention rates will be calculated as the percentage of class participants providing follow up data post intervention.

Time frame
during and after 6 month of using the KESS intervention
4

Adverse event data (Phase 2)

Adverse event data will be collected by the research team monthly (via email and telephone) and assessed by the Principal Investigator and Clinical Leads for causality to determine if events are related to the interventions receipt.

Time frame
during the 6 month intervention period

Other outcomes

Sponsors and contacts

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Northumbria University

Lead sponsor

Orthopaedic Research UK

Collaborator

HealthWorks Newcastle Upon Tyne

Collaborator

KOKU Health CIC

Collaborator

The University of Manchester

Collaborator

Glasgow Caledonian University

Collaborator

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