Hospitalized Older Medical Patients Clinical Trial
Official title:
In-hospital and Post-discharge Training of Older Medical Patients
| NCT number | NCT01964482 |
| Other study ID # | H-2-2012-115 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | October 2018 |
| Verified date | December 2018 |
| Source | Copenhagen University Hospital, Hvidovre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 158 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Copenhagen University Hospital, Hvidovre | Hvidovre |
| Lead Sponsor | Collaborator |
|---|---|
| Copenhagen University Hospital, Hvidovre |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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) |