Keep-On-Keep-Up (KOKU)

University of Manchester

Status: Enrolling

Conditions: Balance; Functional Decline; Falls Prevention

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06687135

PURE ID: 273223769

Details and patient eligibility

About

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.

Full description

• Eligible participants will be advised to use KOKU (a digital health wellbeing app) three times per week for 20-30 minutes
• The KOKU intervention will run for 12 weeks to test the effectiveness
• The control group will be given FaME/ OTAGO exercise and falls prevention information leaflets without KOKU
• Assessments will take place at baseline, 6 weeks, and at the end of the12-week period
• Outcome measures to be used include a series of standardised tests and questionnaires and each participant will be aided in completing these measures
• At the end of the 12 weeks, focus groups and interviews will be conducted to assess the care managers, carers and participant's perspectives regarding the effectiveness of the KOKU digital program and its usability

Enrollment: 196 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

KOKU

Experimental group

Description:

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.

Treatment:

Other: KOKU

FaME/OTAGO

Active Comparator group

Description:

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.

Treatment:

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