Overview

This trial is active, not recruiting.

Condition hospitalized older medical patients
Treatment strength training
Sponsor Copenhagen University Hospital, Hvidovre
Start date October 2013
End date January 2018
Trial size 54 participants
Trial identifier NCT01964482, H-2-2012-115

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Supervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home
strength training
Strength training followed by intake of a protein drink
(No Intervention)
Usual care

Primary Outcomes

Measure
Mobility using the de Morton Mobility Index (DEMMI)
time frame: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title In-hospital and Post-discharge Training of Older Medical Patients
Principal investigator Mette M Pedersen, PhD Student
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Copenhagen University Hospital, Hvidovre.