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)

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, April 2016

27039381

Mette Merete Pedersen, Janne Petersen, Nina Beyer, Lars Damkjær, Thomas Bandholm

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. 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. 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. ClinicalTrials.gov: NCT01964482 .