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

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ClinicalTrials.gov Identifier: NCT01964482
Recruitment Status : Recruiting
First Posted : October 17, 2013
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre

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.


Condition or disease Intervention/treatment Phase
Hospitalized Older Medical Patients Other: Strength training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In-hospital and Post-discharge Training of Older Medical Patients
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Isometric knee-extension strength in dominant leg [ Time Frame: At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge ]
    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.

  2. Hand-grip strength of dominant hand [ Time Frame: Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge ]
    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.

  3. 30-sec sit to stand test [ Time Frame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge ]
    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.

  4. Habitual gait speed [ Time Frame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge ]
    Patients will be asked to walk a 4-meter straight walk at their usual pace starting from a standing position.

  5. 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) ]
    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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964482


Contacts
Contact: Mette M Pedersen, PhD student +4538623350 mette.merete.pedersen@regionh.dk
Contact: Thomas Q Bandholm, PhD +4538626344 thomas.quaade.bandholm@regionh.dk

Locations
Denmark
Copenhagen University Hospital, Hvidovre Recruiting
Hvidovre, Denmark, 2650
Contact: Mette M Pedersen, PhD Student    +4538623350    mette.merete.pedersen@regionh.dk   
Contact: Thomas Q Bandholm, PhD    +4538626344    thomas.quaade.bandholm@regionh.dk   
Principal Investigator: Mette M Pedersen, PhD Student         
Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Merete Pedersen, PhD student, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01964482     History of Changes
Other Study ID Numbers: H-2-2012-115
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Keywords provided by Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre:
Hospitalization
Older
Medical patient
Strength training