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

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.

Study Overview

• Status: Completed
• Conditions: Hospitalized Older Medical Patients
• Intervention / Treatment: Other: Strength training

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital, Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Investigators: Principal Investigator: Mette M Pedersen, PhD Student, Hvidovre Hospital, University of Copenhagen; Study Director: Thomas Q Bandholm, PhD, Hvidovre Hospital, University of Copenhagen; Study Director: Janne Petersen, PhD, Hvidovre Hospital, University of Copenhagen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hospitalization; Older; Strength training; Medical patient
• Other Study ID Numbers: H-2-2012-115