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).
abstract: BACKGROUND
  Hospitalization in older adults is characterized by physical inactivity and a risk of losing function and independence. Systematic strength training can improve muscle strength and functional performance in older adults. Few studies have examined the effect of a program initiated during hospitalization and continued after discharge. We conducted a feasibility study prior to this trial and found a progression model for loaded sit-to-stands feasible in older medical patients. This study aims to determine whether a simple supervised strength training program for the lower extremities (based on the model), combined with post-training protein supplementation initiated during hospitalization and continued at home for 4 weeks, is superior to usual care on change in mobility 4 weeks after discharge in older medical patients.
  
  
  METHODS
  Eighty older medical patients (65 years or older) acutely admitted from their own homes will be included in this randomized, controlled, parallel-group, investigator-blinded, superiority trial. After baseline assessments patients will be randomized to (1) intervention: progressive strength training during hospitalization and after discharge (home-based), or (2) control: usual care. Shortly after discharge, 4 weeks after discharge (primary end point) and 6 months after discharge patients will be assessed in their own homes. The intervention encompasses strength training consisting of two lower extremity exercises (sit-to-stand and heel raise) daily during hospitalization and three times per week for 4 weeks after discharge. Both exercises follow pre-defined models for progression and will be performed for three sets of 8-12 repetitions maximum in each training session. Thereafter, the patient will be asked to consume a protein supplement given orally containing 18 g milk-based protein. The primary outcome will be change in the de Morton Mobility Index score from baseline to 4 weeks after discharge. Secondary outcomes will be 24-h mobility level, isometric knee extension strength, the 30-sec sit-to-stand test, habitual gait speed, hand-grip strength, and Activities of Daily Living.
  
  
  CONCLUSIONS
  We chose to investigate the effect of a minimal time-consuming treatment approach, i.e. two well-performed strength training exercises combined with protein supplementation, to facilitate implementation in a busy clinical care setting, given a positive trial outcome.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01964482 .
authors.affiliation: Optimed, Clinical Research Centre and Physical Medicine Research-Copenhagen (PMR-C), Department of Physiotherapy, Copenhagen University Hospital, Hvidovre, Denmark. mette.merete.pedersen@regionh.dk.
authors.forename: Mette Merete
authors.initials: MM
authors.lastname: Pedersen
authors.affiliation: Optimed, Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.|Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Janne
authors.initials: J
authors.lastname: Petersen
authors.affiliation: Musculoskeletal Rehabilitation Research Unit, Bispebjerg and Frederiksberg Hospitals, University of Copenhagen, Copenhagen, Denmark.|Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Nina
authors.initials: N
authors.lastname: Beyer
authors.affiliation: Department of Rehabilitation, Copenhagen Municipality Health Administration, Copenhagen, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Damkjær
authors.affiliation: Optimed, Clinical Research Centre and Physical Medicine Research-Copenhagen (PMR-C), Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.|Department of Orthopaedic Surgery, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bandholm
mesh_terms: D000203:Activities of Daily Living; D000367:Age Factors; D000368:Aged; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003718:Denmark; D005260:Female; D005526:Food, Formulated; D015577:Geriatric Assessment; D006801:Humans; D007297:Inpatients; D008297:Male; D008894:Milk Proteins / Q000008:administration & dosage*; D051346:Mobility Limitation; D053580:Muscle Strength; D009752:Nutritional Status; D010351:Patient Discharge; D012107:Research Design; D055070:Resistance Training; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008894:Milk Proteins
keywords: Cross-continuum; Hospitalization; Mobility; Older medical patients; Progressive strength training; Supervision