Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients

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.

Inclusion Criteria:

1. Male and female subjects ≥7 to 60 years of age

2. >30% TBSA burned, as estimated by the physician in charge

3. No evidence of organ failure

Exclusion Criteria:

1. Active Tuberculosis- based on clinical symptoms and/or abnormal chest x-ray in the
upper lobe.

2. Electrical burns

3. Mental retardation or autism or any other mental disorder that makes it impossible to
participate in an exercise program

4. Pregnancy