Keep-On-Keep-Up (KOKU)

NCT06687135 | Completed DMC

• 1 other identifier: PURE ID: 273223769
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

Falls are the primary cause of fatal and non-fatal accidental injuries in older adults. Around a third of community-dwelling older adults fall per year with high associated personal and societal costs. The World Falls Prevention Guidelines recommend balance challenging, functional exercise programmes for falls prevention but there can be low uptake and adherence in community settings. A digital, NHS approved programme Keep-On-Keep-Up (KOKU) was co-developed with older adults and therapists, to provide progressive, evidence-based exercises and to raise awareness of home hazards and ways to improve bone health, nutrition and hydration. This trial aims to investigate the effectiveness of the KOKU digital strength and balance programme for improving balance, function and reducing falls risk in community dwelling older adults. Objective: The purpose of this study is to investigate the effectiveness and cost-effectiveness of an NHS (National Health Service) approved, digital falls prevention intervention; (Keep On Keep Up (KOKU) - see https://kokuhealth.com) for improving balance, maintaining function and reducing falls risk in community dwelling older adults. Design: A two-arm randomised controlled trial. Participants and setting: Community-dwelling older adults aged 65 years and older. Interventions: Digital 12-week strength and balance programme, plus standard care (falls prevention exercises advice and leaflet) against standard care only. Main outcome measures: The primary outcome measure is balance function at 12 weeks post-baseline, as assessed by the Berg Balance scale (BBS). Secondary outcomes include: healthcare utilisation and health-related quality of life, fear of falling, mobility, self-reported physical activity, falls risk, pain, mood, fatigue, and self-reported falls over a 3-month period. Randomisation will take place after participants are recruited and baseline data is collected.

Conditions

Balance; Falls Prevention; Functional Decline

Keywords

Balance; Falls Prevention; Functional Decline; Older People; Gerotechnology; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  The primary outcome measure is balance function as measured by the Berg Balance Scale (BBS). The BBS is a 14-item scale designed to measure balance of the older adult in a clinical setting. Each item consists of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. The total score equals 56. Score of \< 45 indicates individuals may be at greater risk of falling (Berg et al., 1992).

  0 Weeks (baseline), 6 weeks and 12 weeks (study completion)

Secondary Outcomes (10)

• European Quality of Life 5 Dimensions (EQ5D-5L)

  0 Weeks (baseline), 6 weeks and 12 weeks (study completion)

• 5-item Geriatric Depression Scale (GDS)

  0 Weeks (baseline), 6 weeks and 12 weeks (study completion)

• Physical Activity Scale for the Elderly (PASE)

  0 Weeks (baseline), 6 weeks and 12 weeks (study completion)

• Short Falls Efficacy Scale-International (FES-I)

  0 Weeks (baseline), 6 weeks and 12 weeks (study completion)

• Five times Sit to Stand Test

  Baseline, 6 weeks and 12 weeks

Study Arms (2)

KOKU

EXPERIMENTAL

A maximum of 196 participants will be recruited to participate in the study, across sites in Greater Manchester and Lancashire, UK. Participants will be randomised into either; * the experimental group (n=98); who will receive the KOKU intervention or * the control group (n=98); who will receive the FaME/ OTAGO exercise and falls prevention information leaflets without KOKU.

Other: KOKU

FaME/OTAGO

ACTIVE COMPARATOR

A maximum of 196 participants will be recruited to participate in the study, across sites in Greater Manchester and Lancashire, UK. Participants will be randomised into either; * the experimental group (n=98); who will receive the KOKU intervention or * the control group (n=98); who will receive the FaME/ OTAGO exercise and falls prevention information leaflets without KOKU.

Other: FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet

Interventions

KOKU OTHER

KOKU is a digital strength and balance programme designed to prevent physical decline and frailty KOKU provides access to personalised, progressive strength and balance exercises. More information can be found at: https://kokuhealth.com/

Also known as: Keep-On-Keep-Up

KOKU

FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet OTHER

A leaflet with information on a combination of strength and balance exercises and walking programs, performed on a weekly basis by older adults at home, or community settings. The exercises can be done individually or in a group setting and are aimed at reducing falls in older adults. More information can be found at: https://fameexercise.com/ and https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf https://www.ageuk.org.uk/information-advice/health-wellbeing/exercise/staying-steady-download-page/#:\~:text=This%20guide%20outlines%20things%20you%20can

Also known as: Fitness-and-Mobility-Exercises (FaME) / OTAGO-Exercise-Program (OEP) and AGE UK Stay Steady Leafletleaflets

FaME/OTAGO

Eligibility Criteria

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

You may qualify if:

• Older adults (aged 60 years and older, inclusive of all genders and ethnicities)
• Are able and willing to provide informed consent (to participate in the study)
• Are able to understand and speak English (to communicate with researchers and understand what the research involves)
• Are able to see and safely use the tablet-based program and read instructions with or without glasses as assessed by the trained research staff (in order to access the intervention)

You may not qualify if:

• Inability to understand the study procedures
• Currently using other digital technologies to exercise (would not be a true experimental or control group participant)
• Medical contraindications to exercise e.g. acute illness, severe congestive cardiac failure, uncontrolled hypertension, recent fracture or surgery; myocardial infarction or stroke in past 6 months; severe cognitive impairment; orthopaedic surgery in last 6 months, or on waiting list to have orthopaedic surgery; wheelchair users; severe auditory or visual impairment; and peripheral neuropathy or other uncontrolled medical (conditions that are likely to compromise the ability to exercise)

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (2)

The University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

Related Links

• Keep On Keep Up (KOKU)
• Fitness and Mobility Exercises (FaME)
• OTAGO Exercise Programme (OEP)

Study Officials

• Emma Stanmore, PhD

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator/ Principal Investigator

Model Details: A two-arm randomised controlled trial.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 13, 2024
• Study Start: July 1, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: April 28, 2026

Record last verified: 2024-07

Locations

GB (2)