Clinical trial NCT01964482: In-hospital and Post-discharge Training of Older Medical Patients
Official title: In-hospital and Post-discharge Training of Older Medical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalized Older Medical Patients
Keywords: Hospitalization
Older
Medical patient
Strength training
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 158
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mobility using the de Morton Mobility Index (DEMMI)
timeFrame: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge
Secondary outcomes:
measure: Isometric knee-extension strength in dominant leg
timeFrame: At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge
measure: Hand-grip strength of dominant hand
timeFrame: Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge
measure: 30-sec sit to stand test
timeFrame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
measure: Habitual gait speed
timeFrame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
measure: 24-hour mobility
timeFrame: 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)
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
Study officials:
affiliation: Hvidovre Hospital, University of Copenhagen
name: Mette M Pedersen, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre Hospital, University of Copenhagen
name: Thomas Q Bandholm, PhD
role: STUDY_DIRECTOR
affiliation: Hvidovre Hospital, University of Copenhagen
name: Janne Petersen, PhD
role: STUDY_DIRECTOR
References:
citation: Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.
citation: Pedersen MM, Petersen J, Beyer N, Larsen HG, Jensen PS, Andersen O, Bandholm T; STAND-Cph collaborative group. A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial. Trials. 2019 Nov 28;20(1):655. doi: 10.1186/s13063-019-3720-x.
citation: Pedersen MM, Petersen J, Beyer N, Damkjaer L, Bandholm T. Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial). Trials. 2016 Apr 1;17:176. doi: 10.1186/s13063-016-1309-1.