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

NCT06447948 | Not Yet Recruiting

• 1 other identifier: Audsley 2024-6365-5990
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Fall Patients

Keywords

Falls Prevention; Ageing Health; Physical activity; Exercise Maintenance; Behaviour Change; Digital health; Older Adults

Outcome Measures

Primary Outcomes (3)

• 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).

  after 1 month of using the KESS intervention

• 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).

  after 1 month of using the KESS intervention

• 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.

  after 6 month of using the KESS intervention

Secondary Outcomes (8)

• Frequency and duration of KOKU App use (Phase 2)

  after 6 month of using the KESS intervention

• Recruitment rates (phase 2)

  after 6 month

• Retention rates (phase 2)

  during and after 6 month of using the KESS intervention

• Adverse event data (Phase 2)

  during the 6 month intervention period

• Fear of falling questionnaire completion (Phase 2)

  Questionnaire completion will be measured at baseline and post intervention (6-months).

Study Arms (1)

Intervention

EXPERIMENTAL

Phase 1 (Acceptability Study) intervention arm. Phase 1 participants (n=10) will test the digital health / falls prevention exercise intervention components (e.g. PA via wearables, digital peer support and home exercise delivered via KOKU App) for 1 month. Phase 2 (Feasibility Study). Intervention Arm. Phase 2 participants (n=30) will test the optimised digital health / falls prevention exercise intervention components for 6 months.

Behavioral: Keep Exercising and Stay Steady

Interventions

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.

Also known as: KESS

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Orthopaedic Research UK: collaborator
• HealthWorks Newcastle Upon Tyne: collaborator
• KOKU Health CIC: collaborator
• The University of Manchester: collaborator
• Glasgow Caledonian University: collaborator

Study Sites (1)

HealthWorks: The Health Resource Centre

Newcastle upon Tyne, Tyne and Wear, NE4 8BE, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Sarah Audsley, PhD

CONTACT

+44 07951000075; s.audsley@northumbria.ac.uk

Gill Barry, PhD

CONTACT

+44 01912437635; gill.barry@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1- Acceptability Study \& Phase 2-Feasibility Study

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 7, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): May 19, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)