A Twice-Daily Individual Targeted Exercise Program in Frail Hospitalised Older Medical In-patients (RCT)

Study Overview
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Brief Summary
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This study will help to determine whether frail older medical inpatients will benefit from targeted exercise sessions performed twice daily while in hospital. Half of the patients will complete targeted strengthening, balance and endurance exercises and the other half, stretching and relaxation exercises. The exercise sessions will be assisted and supported by a senior physiotherapist.

Detailed Description
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It is well known that older medical patients can experience functional decline following an acute hospital admission and this can persist for up to three months. The targeted exercises are designed to prevent this functional decline by maintaining the patients' strength, balance and endurance. To counterbalance the considerable time spent with the physiotherapy services in the intervention arm, the control group will receive stretches and relaxation exercises. Patients' length of stay is the primary outcome measure. Their physical performance and quality of life at discharge and at 3 months post discharge and their readmission rates are the secondary outcome measures.

Official Title
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A Randomised Controlled Trial to Measure the Effects of Twice-Daily Individual, Targeted, Strengthening, Balance and Endurance Exercise Sessions on Mobility, Quality of Life and Healthcare Utilisation for Frail Older Medical In-patients

Conditions
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Frail Older Adults

Intervention / Treatment
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* Other: Intervention exercise
* Other: Sham Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medical patients anticipated length of stay greater than 2 days planned for discharge home mobility aid and /or assistance required on admission Exclusion Criteria: contraindications to exercise unable to follow commands in the English language unable to exercise with the assistance of one person only when active palliative care is required when full isolation for containment of a contagious infection is required

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention exercise<br>Twice daily, individual, targeted, strengthening, balance and endurance exercise sessions | Other: Intervention exercise<br>* Twice daily, individual, targeted, strengthening, balance and endurance exercises for the duration of the hospital stay, prescribed and delivered by a senior physiotherapist.<br>* Other names: Augmented Prescribed Exercise Program;|
| Sham Comparator: Sham exercise<br>Twice daily, individual, stretching and relaxation exercise sessions | Other: Sham Exercise<br>* Twice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Patients length of hospital stay is recorded at the time of discharge from electronic admissions data | At time of discharge from hospital (an expected average of 8 days post admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Performance | The Short Physical Performance Battery will be completed, which includes a timed 4 m walk. Patients can score 0-12; scoring higher with better physical performance. | At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge | 
| Quality of Life | The EQ5D-5L will be completed by the patient. | At time of discharge from hospital (an expected average of 8 days post admission); and again at 3 months post discharge | 
| Re-admission Rate | The number of admissions within 3 months following the index admission will be recorded from hospital electronic records | From the time of hospital discharge to 3 months post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, older adult, hospital, exercise, randomised control trial, functional decline