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

NCT06447948 | Recruiting

• 1 other identifier: Audsley 2024-6365-5990
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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 peer 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 community of practice group. The group will work with the research team to create the home exercise programme. 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 (2)

• Health Intervention Acceptability Questionnaire

  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).

  8 months / after completion of the the KESS intervention

• Physical Activity Scale for the Elderly questionnaire (PASE)

  Intervention adherence will be ascertained via weekly PASE scores measuring physical activity and strength and balance exercise. The PASE questionnaire asks respondents 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 8 month of using the KESS intervention

Secondary Outcomes (4)

• Recruitment rates (phase 2)

  after 8 month

• Retention rates (phase 2)

  during and after 8 month of using the KESS intervention

• Adverse event data (Phase 2)

  during the 6 month intervention period after the inital falls prevention programme ends

• Semi-structured interviews regarding KESS Acceptability

  after the 8 month intervention period.

Study Arms (1)

Intervention

EXPERIMENTAL

Single Arm Feasibility Study: Study participants (n=30) will test the exercise maintenance intervention components for up to 9 months.

Behavioral: Keep Exercising and Stay Steady

Interventions

Keep Exercising and Stay Steady BEHAVIORAL

Eight KESS sessions will be delivered via a motivational interview approach, in face to face group sessions, delivered by postural stability instructors at the participants usual class venue. Guest speakers will deliver specialist education. Participants will receive text message reminders and telephone follow up for non attendance. Three KESS sessions will take place before programmes end with education and various behaviour change strategies being delivered to help participants develop an intention of continuing exercising/ being active when programmes end. Five sessions will take place over a 6 months duration when programmes end with behavior change strategies and education being delivered that aims to bridge the gap between behavioral intentions and actions to encourage the long-term continuation of good physical activity habits and continued social interactions.

Also known as: KESS

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unable to independently walk 5 metres with or 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 (4)

Healthworks, The Lemington Centre, Wallbottle

Newcastle upon Tyne, Tyne and Wear, NE15 8RZ, United Kingdom

RECRUITING

Healthworks, Trinity Church, Gosforth

Newcastle upon Tyne, Tyne and Wear, NE3 4AG, United Kingdom

RECRUITING

HealthWorks: The Health Resource Centre, Benwell

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

RECRUITING

Healthworks, East End Pool, Byker

Newcastle upon Tyne, Tyne and Wear, NE6 1AL, United Kingdom

RECRUITING

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- Intervention Development \& Phase 2-Feasibility Study

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: June 7, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)