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Table 1 Trial registration data

From: 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)

Data category

Information

Primary registry and trial identification number

ClinicalTrials.gov: NCT01964482

Data of registration in primary registry

14 October 2013

Secondary identifying numbers

The Ethics Committee of the Capital Region of Denmark: H-2-2012-115

The Danish Data Protection Agency: 2007-58-0015

Source(s) of monetary or material support

Danish Regions/The Danish Health Confederation, The Lundbeck Foundation (UCSF) (grant numbers FP 07/2012, FP 48/2012 and FP 61/2013), the Research Foundation of Hvidovre Hospital, the Capital Region of Copenhagen, and The Danish Foundation for Research in Physiotherapy

Primary sponsor

Danish Regions/The Danish Health Confederation

Secondary sponsor(s)

The Lundbeck Foundation (UCSF), the Research Foundation of Hvidovre Hospital, the Capital Region of Copenhagen, and The Danish Foundation for Research in Physiotherapy

Contact for public queries

MMP, TB (mette.merete.pedersen@regionh.dk)

Contact for scientific queries

MMP, TB. Clinical Research Centre, Hvidovre Hospital, University of Copenhagen, Denmark

Public title

In-hospital and post-discharge training of older medical patients

Scientific title

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)

Country of recruitment

Denmark

Health condition(s) or problem(s) studied

Progressive strength training in older medical patients

Intervention(s)

Intervention: strength training daily during hospitalization and 3 times per week for 4 weeks after discharge

Control: usual care

Key inclusion and exclusion criteria

Inclusion criteria: age ≥65 years; acutely admitted from own home to the Emergency Department at Hvidovre Hospital, Denmark

Exclusion criteria: terminal illness; in treatment for a diagnosed cancer; diagnosis of chronic obstructive pulmonary disease (COPD) and participation in a COPD rehabilitation program; living outside the municipalities of Copenhagen and Broendby; inability to speak or understand Danish; inability to cooperate in tests/exercises; an expected hospitalization >24 h; assigned to physical rehabilitation in the community; a Cumulated Ambulation Score (CAS) of 0 in the sit-to-stand item

Study type

Interventional

Allocation: randomized

Blinding: investigator blind

Date of first enrollment

September 2013

Target sample size

80

Recruitment status

Recruiting

Primary outcome(s)

The de Morton Mobility Index

Timeframe: change from baseline to 4 weeks after discharge (end of intervention)

Key secondary outcomes

24-h mobility measured by activPAL3TM; isometric knee extension strength in the dominant leg; the 30-sec sit-to-stand test; habitual gait speed; hand-grip strength in dominant hand; the Barthel Index 20