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

July 27, 2026 updated by: Northumbria University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE15 8RZ
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE3 4AG
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 8BE
        • Recruiting
        • HealthWorks: The Health Resource Centre, Benwell
        • Sub-Investigator:
          • Gill Barry, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah Audsley, PhD
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE6 1AL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Eligibility criteria:

  • Community dwelling older adults
  • Enrolled on a Healthworks FaME programme in the Northeast region of England.
  • Able to provide informed written consent.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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

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.

Other Names:
  • KESS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Intervention Acceptability Questionnaire
Time Frame: 8 months / after completion of the the KESS intervention
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)
Time Frame: after 8 month of using the KESS intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rates (phase 2)
Time Frame: after 8 month
Recruitment rates will be recorded as the number of participants invited and the percentage consenting to enter the feasibility study.
after 8 month
Retention rates (phase 2)
Time Frame: during and after 8 month of using the KESS intervention
Retention rates will be calculated as the percentage of class participants providing follow up data post intervention.
during and after 8 month of using the KESS intervention
Adverse event data (Phase 2)
Time Frame: during the 6 month intervention period after the inital falls prevention programme ends
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.
during the 6 month intervention period after the inital falls prevention programme ends
Semi-structured interviews regarding KESS Acceptability
Time Frame: after the 8 month intervention period.
Intervention acceptability will be qualitatively examined via semi-structured interviews with up to n=20 participants. Interview Schedules will be informed by the Theoretical Framework of Acceptability and Seniors Technology Acceptance Model.
after the 8 month intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

Glasgow Caledonian University
Orthopaedic Research UK
HealthWorks Newcastle Upon Tyne
KOKU Health CIC
The University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

April 1, 2026

Study Completion (Estimated)

October 19, 2026

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Audsley 2024-6365-5990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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