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NCT06687135
Keep-On-Keep-Up (KOKU)
NA trial testing KOKU in Balance in 196 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University of Manchester |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 196 |
| Start date | 12 July 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- KOKU
- FaME / OTAGO leaflet and AGE UK Stay Steady Leaflet
Conditions studied
- Balance — all drugs for Balance →
- Falls Prevention — all drugs for Falls Prevention →
- Functional Decline — all drugs for Functional Decline →
Sponsor
University of Manchester
Who can join
60 and older, any sex, with Balance or Falls Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06687135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Manchester trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06687135 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Manchester
- Last refreshed: 13 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06687135.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing