In-hospital and Post-discharge Training of Older Medical Patients

Study Overview
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Brief Summary
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The project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization. Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve sufficient power to look more deeply into our secondary outcomes. This will constitute a secondary part of the trial (started Nov. 2016). The primary trial report will include data for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence, the primary completion date for part 1 was April 2016 and the study completion date for part 1 was Oct 2016. The trial status is still recruiting although this applies to part 2 of the study.

Official Title
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In-hospital and Post-discharge Training of Older Medical Patients

Conditions
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Hospitalized Older Medical Patients

Intervention / Treatment
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* Other: Strength training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=65 years of age admitted from own home Exclusion Criteria: Terminal illness In treatment for diagnosed cancer Assigned to physical rehabilitation in community Chronic Obstructive Pulmonary Disease (COPD) patients participating in organized rehabilitation Living outside of the municipalities of Copenhagen and Broendby Not able to talk and understand danish Not able to cooperate on tests/exercises Hospitalized < 24 hours A Cumulated Ambulation Score (CAS) of 0 in the sit-to-stand item

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training<br>Supervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home | Other: Strength training<br>* Strength training followed by intake of a protein drink<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility using the de Morton Mobility Index (DEMMI) | The DEMMI is an advanced instrument for accurately measuring the mobility of older people across clinical settings (www.demmi.org.au). The primary analysis for the primary outcome is the change in the DEMMI score from baseline to the assessment 4 weeks after discharge (end of intervention). The primary analysis will follow the intention-to-treat principle (last observation carried forward) and be unadjusted in order to determine a systematic group-difference in the change from baseline to 4 weeks post discharge (end of training) for the primary outcome. | Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric knee-extension strength in dominant leg | Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient. | At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge | 
| Hand-grip strength of dominant hand | Isometric handgrip strength will be measured in the dominant hand using a handheld dynamometer (Digi-II; Saehan). The patient will be placed in a sitting position in an armchair, with the lower arm placed on the arm rest and an elbow flexion of 90 degrees. The patients will be asked to squeeze the handle as forcefully as possible for 5 secs. Handgrip strength will be expressed in kilograms. | Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge | 
| 30-sec sit to stand test | The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest. | Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge | 
| Habitual gait speed | Patients will be asked to walk a 4-meter straight walk at their usual pace starting from a standing position. | Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge | 
| 24-hour mobility | The patients will be asked to wear an ActivPAL3 activity monitor (PAL Technologies Ltd, Scotland) on the thigh during hospitalization, the first week after discharge, the first weeks after the 4-week assessment and the first week after the 26-week assessment. | Admittance to discharge, discharge to 1 week post discharge, 4 weeks post discharge to 5 weeks post discharge, 26 weeks post discharge to 27 weeks post discharge (4 x 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospitalization, Older, Medical patient, Strength training