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 4Â 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 >24Â 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 4Â 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 |