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

NCT01964482 | Completed DMC

• 1 other identifier: H-2-2012-115
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalized Older Medical Patients

Keywords

Hospitalization; Older; Medical patient; Strength training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Isometric knee-extension strength in dominant leg

  At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge

• Hand-grip strength of dominant hand

  Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge

• 30-sec sit to stand test

  Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge

• Habitual gait speed

  Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge

• 24-hour mobility

  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)

Study Arms (2)

Strength training

EXPERIMENTAL

Supervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home

Other: Strength training

Usual care

NO INTERVENTION

Usual care

Interventions

Strength training OTHER

Strength training followed by intake of a protein drink

Strength training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>=65 years of age
• admitted from own home

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (3)

• 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.

  PMID: 36136804 DERIVED

• 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.

  PMID: 31779693 DERIVED

• 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.

  PMID: 27039381 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mette M Pedersen, PhD Student

  Hvidovre Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Thomas Q Bandholm, PhD

  Hvidovre Hospital, University of Copenhagen

  STUDY DIRECTOR

• Janne Petersen, PhD

  Hvidovre Hospital, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

DK (1)