BalanceNCT06687135
Keep-On-Keep-Up (KOKU)
A study testing KOKU and FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet in people with Balance and Falls Prevention, run by University of Manchester at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balance, Falls Prevention, Functional Decline
- What is being tested?
- KOKU and FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2024to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The University of Manchester
Manchester, Greater Manchester, M13 9PL
University of Manchester
Manchester, Greater Manchester, M13 9PL
About this study
Official title: The Effectiveness of a Digital Falls Prevention Programme (KOKU) Versus Usual Care to Improve Balance, Falls Risk and Function in Older Adults
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:
Read more
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.
Read the detailed 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
- Conditions
- Balance, Falls Prevention, Functional Decline
- Being tested
- KOKU, FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet
- Keywords
- Balance, Falls Prevention, Functional Decline, Older People, Gerotechnology, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOKUOther
Also called Keep-On-Keep-Up
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/
FaME / OTAGO leaflet and AGE UK Stay Steady LeafletOther
Also called Fitness-and-Mobility-Exercises (FaME) / OTAGO-Exercise-Program (OEP) and AGE UK Stay Steady Leafletleaflets
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Secondary outcomes (10)
European Quality of Life 5 Dimensions (EQ5D-5L)
The 5-level EQ-5D version (EQ-5D-5L) measures health-related quality of life and consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient selects the most appropriate statement in each of the five dimensions which results in a 1-digit number for the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Higher scores indicate better health-related quality of life. Minimum score is -0.285 and maximum score is 1.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
5-item Geriatric Depression Scale (GDS)
Mood will be assessed using the 5-item Geriatric Depression Scale (GDS). This screening tool for depression in older adults is validated for older adults in a wide range of settings (Hoyl et al., 1999). The scale ranges from minimum score of 0 indicating no depression to 5 indicating higher level of depressive symptoms.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Physical Activity Scale for the Elderly (PASE)
To assess the participant's physical activity levels. The PASE score theoretically ranges from 0 indicating no physical activity to a maximum score of over 400 (depending on the intensity, frequency and duration of the activities) indicating greater levels of physical activity.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Short Falls Efficacy Scale-International (FES-I)
To assess confidence in performing activities of daily living without falling.(concerns about falling). The scale ranges from 7 to 28 with 7 as the minimum score indicating no concerns about falling and 28 is the maximum score indicating severe concern about falling.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Five times Sit to Stand Test
The 5-times Sit-to-Stand Test assesses lower body strength, lower limb power, and functional mobility. It measures the time in seconds taken to complete five consecutive sit-to-stand movements as quickly as possible from a seated position. There are no fixed minimum or maximum scores in time, higher scores indicate worse performance. For older adults a time greater than 12 seconds is often used as a threshold indicating an increased risk of falls or mobility limitations.
Measured: Baseline, 6 weeks and 12 weeks
Assessment of Falls Risk Tool (FRAT)
To assess risk of falls, 0 is the minimum score indicating no or very low risk of falls and 20 is the maximum score indicating a very high risk of falls.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
System Usability Scale (SUS)
To assess the usability of KOKU. The SUS provides a score between 0 and 100 with 0 the minimum score indicating poor usability and 100 the maximum score indicating excellent usability.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Theoretical Framework for Acceptability (TFA)
To assess the usability of KOKU. The TFA is reported qualitatively to capture a detailed understanding of acceptability in healthcare settings.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
12 Item Short Scale for Measuring Technology Commitment
To assess the usability of KOKU. The 12 Item Short Scale for Measuring Technology Commitment follows a likert-type scale (ranging 1 to 5 for each item). The total score is then calculated by summing the items. The minimum score is 12 representing the lowest commitment to technology and the maximum score is 60 indicating highest level of commitment to technology.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
The Short Version of the User Experience Question
To assess the usability of KOKU. The Short Version of the User Experience Question (UEQ) is composed of 6 dimensions of user experience (attractiveness, efficiency, perspicuity, dependability, stimulation and novelty) rated on a 7 point Likert scale ranging from 1 to 7. The minimum score is 6 indicating low user experience and the maximum score is 42 indicating high user experience.
Measured: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Jul 2024
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Emma Stanmore, University of Manchester
- Investigators
- Emma Stanmore, PhD, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687135
- Sponsor's protocol ID
- PURE ID: 273223769
- Status last verified
- Jul 2024
- First submitted
- 4 Nov 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Digital Falls Prevention Programme (KOKU) Versus Usual Care to Improve Balance, Falls Risk and Function in Older Adults
- ClinicalTrials.gov ID
- NCT06687135
- Acronym / sponsor ID
- PURE ID: 273223769
- Conditions
- Balance, Falls Prevention, Functional Decline
- Keywords
- Balance, Falls Prevention, Functional Decline, Older People, Gerotechnology, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A two-arm randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| KOKU | Experimental | Other: KOKUA 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. |
| FaME/OTAGO | Active comparator | Other: FaME / OTAGO leaflet and AGE UK Stay Steady LeafletA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOKUAlso: Keep-On-Keep-UpKOKU 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/ | Other | KOKU |
| FaME / OTAGO leaflet and AGE UK Stay Steady LeafletAlso: Fitness-and-Mobility-Exercises (FaME) / OTAGO-Exercise-Program (OEP) and AGE UK Stay Steady LeafletleafletsA 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 | Other | FaME/OTAGO |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
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).
10 secondary outcomes
European Quality of Life 5 Dimensions (EQ5D-5L)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
5-item Geriatric Depression Scale (GDS)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Physical Activity Scale for the Elderly (PASE)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Short Falls Efficacy Scale-International (FES-I)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Five times Sit to Stand Test
Time frame: Baseline, 6 weeks and 12 weeks
Assessment of Falls Risk Tool (FRAT)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
System Usability Scale (SUS)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Theoretical Framework for Acceptability (TFA)
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
12 Item Short Scale for Measuring Technology Commitment
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
The Short Version of the User Experience Question
Time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Keep On Keep Up (KOKU)Link provided by the sponsor.
- Fitness and Mobility Exercises (FaME)Link provided by the sponsor.
- OTAGO Exercise Programme (OEP)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Stanmore, PhD principal investigator
The University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOKU and FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet in people with Balance and Falls Prevention, run by University of Manchester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) (time frame: 0 Weeks (baseline), 6 weeks and 12 weeks (study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.