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Clinical Trials/NCT01964482
NCT01964482
Completed
Not Applicable

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

Copenhagen University Hospital, Hvidovre1 site in 1 country158 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hospitalized Older Medical Patients
Sponsor
Copenhagen University Hospital, Hvidovre
Enrollment
158
Locations
1
Primary Endpoint
Mobility using the de Morton Mobility Index (DEMMI)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre
Responsible Party
Principal Investigator
Principal Investigator

Mette Merete Pedersen

PhD student

Copenhagen University Hospital, Hvidovre

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mobility using the de Morton Mobility Index (DEMMI)

Time Frame: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge

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.

Secondary Outcomes

  • Hand-grip strength of dominant hand(Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge)
  • 30-sec sit to stand test(Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge)
  • 24-hour mobility(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))
  • Isometric knee-extension strength in dominant leg(At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge)
  • Habitual gait speed(Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge)

Study Sites (1)

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