Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients
Condition: Muscle Weakness; Late Effect of Burn; Muscle; Fatigue, Heart; Burn Rehabilitation
MeSH terms: Muscle Weakness; Burns
Study type: Interventional

Summary: 
      This study will measure efficacy of early in-patient exercise as an adjunct to current
      Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to
      assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10)
      carried out soon after admission until hospital discharge (including during the BICU stay and
      time on ventilation).
    

Detailed description: 
      After severe burns (≥ 30% total body surface area [TBSA] burns, patients enter a persistent
      and extensive hypermetabolic and catabolic state. Unfortunately, burn-induced muscle
      catabolism is exacerbated by the prolonged bed rest and inactivity that accompanies
      hospitalization, leading to further loss of muscle mass and extreme weakness. The persistence
      of weakness, fatigue, and muscle catabolism from prolonged bed rest and inactivity during the
      acute care stage ultimately delays rehabilitation and return to normal physical activities.
      Studies conducted in non-burn patients have shown that, aside from decreasing muscle mass,
      prolonged bed rest has a host of other negative physiological consequences.

      The primary purpose of this randomized, controlled, multicenter study is being conducted to
      determine the efficacy of early in-patient exercise, when used as an adjunct to standard of
      care (SOC), in improving recovery of adults from burns. The secondary purpose is to assess
      the efficacy of a personalized, structured, and quantifiable exercise program (hereafter
      referred to as MP10) carried out soon after admission until hospital discharge (including
      during the BICU stay and time on ventilation). This objective will be met through a
      multicenter trial in children and adults (7 - 60 years) with ≥30% TBSA burns. Outcome
      variables will include BICU days, ventilator days, hospital days, peak treadmill time, and
      lean body mass and psychosocial function (See Section 8 for details).

      Methods: Ninety-six subjects will be recruited from four sites (24 subjects each) for this
      study and all genders and ethnicities will be invited. All subject will have TBSA > 30% and
      be ages 7-60 years of age. The first objective of this multicenter study will be to
      characterize the SOC related to physical/occupational therapy of inpatients at four U.S. burn
      centers, through 25 question surveys. The second portion of the project will involve exercise
      research. The objective is to assess the efficacy of MP10, in conjunction with existing SOC,
      in reducing debilitation among discharged burn patients. This will be initiated following
      surgeon's prescription, roughly 3-5 days following the first surgery after admission.

      Ergonomic exercise training for the in-patient subjects will be conducted using Leg and Arm
      Ergometer equipment, and the training period will be daily for 10 minutes. The duration will
      be the duration the patient is held in the Burn Intensive Care Unit (BICU). Testing will
      include the following: Lean mass (assessed via dual energy x-ray absorptiometry (DEXA),
      Cardiopulmonary and muscle endurance test (peak VO2 on treadmill test), and weekly 6 minute
      walk test.

      Data Analysis: A repeated measure ANOVA will be calculated using lean body mass and peak VO2
      as dependent variables with the independent variables of TBA%, duration of hospital stay (and
      days of ergonomic exercise), ventilator days, and demographics. The purpose of this study is
      to measure efficacy of exercise training while in BICU for thermal injury patients.
    

Intervention name(s): Exercise + SOC PT/OT; SOC PT/OT
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Burn; Exercise; Ergometer; MP-10