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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01964482
Enrollment
158
Registered
2013-10-17
Start date
2013-10-31
Completion date
2018-10-31
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalized Older Medical Patients

Keywords

Hospitalization, Older, Medical patient, Strength training

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.

Interventions

OTHERStrength training

Strength training followed by intake of a protein drink

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mobility using the de Morton Mobility Index (DEMMI)Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after dischargeThe 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

MeasureTime frameDescription
Isometric knee-extension strength in dominant legAt admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after dischargeIsometric 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.
Hand-grip strength of dominant handAdmittance (baseline), discharge, 4 weeks post discharge and 26 weeks post dischargeIsometric 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.
30-sec sit to stand testAdmittance (baseline), discharge, 4 weeks post discharge, 26 weeks post dischargeThe patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest.
Habitual gait speedAdmittance (baseline), discharge, 4 weeks post discharge, 26 weeks post dischargePatients will be asked to walk a 4-meter straight walk at their usual pace starting from a standing position.
24-hour mobilityAdmittance 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)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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026