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Feasibility of a trial design to support recovery of outdoor mobility following a broken hip

Outdoor mobility after hip fracture: a feasibility randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16147125
Enrollment
60
Registered
2024-01-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Support for older people who have broken a hip to recover enough to go outdoors Injury, Occupational Diseases, Poisoning

Interventions

A member of the direct care team will screen all patients admitted to the hospital ward with a broken hip to see if they could take part in the study. Patients aged 60 years or more, admitted to hospi

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants: 1. Adults aged 60 years or more 2. Admitted to hospital from (and planned discharge to) home 3. Self-reported outdoor mobility in the three-months pre-fracture 4. Surgically treated for hip fracture 5. Able to consent and participate Participants recruited under the above ‘inclusion criteria’ whose circumstances change (e.g., planned discharge to home but then discharged to nursing/residential care) will be withdrawn before randomisation. They will not be replaced Professionals: Therapists involved in the intervention arm of the feasibility trial, and managers who oversee services involved in the delivery of the intervention within the feasibility trial

Exclusion criteria

Exclusion criteria: Participants: 1. Adults aged less than 60 years 2. Admitted to hospital from (or planned discharge to) nursing/residential care 3. No self-reported outdoor mobility in the three-months pre-fracture 4. Non-surgically treated for hip fracture, 5. Who are likely to require two or more persons to support mobility on discharge 6. Who are unable to consent or participate Professionals: Therapists not involved in the intervention arm of the feasibility trial, and managers who do not oversee services involved in the delivery of the intervention within the feasibility trial

Design outcomes

Primary

MeasureTime frame
Fidelity measured using: 1. Therapist session audio recordings at each intervention session 2. Intervention and usual care questionnaires completed by the physiotherapist/occupational therapist/therapy assistant after each supervised session with a participant 3. Semi-structured interviews/focus groups with participants, therapists, and managers of services involved in the delivery of the intervention 12 weeks post-randomisation

Secondary

MeasureTime frame
1. Acceptability measured using: 1.1. Semi-structured interviews/focus groups with participants, therapists, and managers of services involved in the delivery of the intervention, at 12 weeks post-randomisation 1.2. Theoretical Framework of Acceptability questionnaire completed by participants and therapists at 12 weeks post-randomisation 2. Barriers and enablers to intervention delivery will be measured using semi-structured interviews/focus groups with participants, therapists, and managers of services involved in the delivery of the intervention at 12 weeks post-randomisation 3. Acceptability, completeness, and descriptive comparison of patient-reported outcome data collection which will be assessed through the collection of patient-reported outcome measures: 3.1. Health-related quality of life measured using the EuroQoL EQ-5D-5L 3.2. Activities of daily living measured using the Nottingham Extended Activities of Daily Living 3.3. Pain measured using the Numeric Rating Scale 3.4. Community mobility measured using the University of Alabama Life Space Assessment 3.5. Mortality measured using medical records 3.6. Additional quantitative outcomes captured will include Falls related self-efficacy measured using the Falls Efficacy Scale-International 3.7. Hospital readmissions measured using participant self-report 3.8. Reason and resource use using a bespoke resource use data collection form Data will be collected at baseline, 6 weeks post-randomisation, 12 weeks post-randomisation, and 6 months post-randomisation (if the timing of randomisation permits this follow-up within the trial data collection window) 3.9. Exercise adherence measured using the Exercise Adherence Rating Scale for the OUTDOOR intervention arm at 6 and 12 weeks post-randomisation 5. Count of eligible, recruited and retained participants measured from randomisation until final follow-up (6 months if the timing of randomisation permits 6-month follow-up within the trial data collection window, 12 w

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026