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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02739464
Other study ID # SHC; IRB #14-0432
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2014
Est. completion date September 25, 2020

Study information

Verified date October 2020
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 25, 2020
Est. primary completion date September 25, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 60 Years
Eligibility 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

Study Design


Intervention

Other:
Exercise + SOC PT/OT

SOC PT/OT


Locations

Country Name City State
United States University of Texas Southwestern Medical Center Dallas Texas
United States University of California-Davis/Shriners Hospitals for Children-Sacramento Davis California
United States University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site) Galveston Texas
United States United States Army Institute of Surgical Research San Antonio Texas

Sponsors (4)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston California State University, Sacramento, United States Army Institute of Surgical Research, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (40)

Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress sy — View Citation

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):118 — View Citation

Bartholomew K, Horowitz LM. Attachment styles among young adults: a test of a four-category model. J Pers Soc Psychol. 1991 Aug;61(2):226-44. — View Citation

Bartholomew, K. and E. Scharfe, Reliability and stability of adult attachment patterns. Personal relationships. J Pers Soc Psychol, 1994. 1: p. 23-43.

Bartone PT. Test-retest reliability of the dispositional resilience scale-15, a brief hardiness scale. Psychol Rep. 2007 Dec;101(3 Pt 1):943-4. — View Citation

Bassey EJ, Bennett T, Birmingham AT, Fentem PH, Fitton D, Goldsmith R. Effects of surgical operation and bed rest on cardiovascular responses to exercise in hospital patients. Cardiovasc Res. 1973 Sep;7(5):588-92. — View Citation

Biensø RS, Ringholm S, Kiilerich K, Aachmann-Andersen NJ, Krogh-Madsen R, Guerra B, Plomgaard P, van Hall G, Treebak JT, Saltin B, Lundby C, Calbet JA, Pilegaard H, Wojtaszewski JF. GLUT4 and glycogen synthase are key players in bed rest-induced insulin r — View Citation

Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. Review. — View Citation

Branski LK, Norbury WB, Herndon DN, Chinkes DL, Cochran A, Suman O, Benjamin D, Jeschke MG. Measurement of body composition in burned children: is there a gold standard? JPEN J Parenter Enteral Nutr. 2010 Jan-Feb;34(1):55-63. doi: 10.1177/0148607109336601 — View Citation

Brooks D, Solway S, Gibbons WJ. ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003 May 1;167(9):1287. — View Citation

Burnsworth B, Krob MJ, Langer-Schnepp M. Immediate ambulation of patients with lower-extremity grafts. J Burn Care Rehabil. 1992 Jan-Feb;13(1):89-92. — View Citation

Convertino V, Hoffler GW. Cardiovascular physiology. Effects of microgravity. J Fla Med Assoc. 1992 Aug;79(8):517-24. Review. — View Citation

Convertino V, Hung J, Goldwater D, DeBusk RF. Cardiovascular responses to exercise in middle-aged men after 10 days of bedrest. Circulation. 1982 Jan;65(1):134-40. — View Citation

Convertino VA, Bisson R, Bates R, Goldwater D, Sandler H. Effects of antiorthostatic bedrest on the cardiorespiratory responses to exercise. Aviat Space Environ Med. 1981 Apr;52(4):251-5. — View Citation

Convertino VA. Effects of exercise and inactivity on intravascular volume and cardiovascular control mechanisms. Acta Astronaut. 1992 Jul;27:123-9. Review. — View Citation

Crandall CG, Shibasaki M, Wilson TE, Cui J, Levine BD. Prolonged head-down tilt exposure reduces maximal cutaneous vasodilator and sweating capacity in humans. J Appl Physiol (1985). 2003 Jun;94(6):2330-6. Epub 2003 Feb 21. — View Citation

DeRoshia CW, Greenleaf JE. Performance and mood-state parameters during 30-day 6 degrees head-down bed rest with exercise training. Aviat Space Environ Med. 1993 Jun;64(6):522-7. — View Citation

Dudley GA, Gollnick PD, Convertino VA, Buchanan P. Changes of muscle function and size with bedrest. Physiologist. 1989 Feb;32(1 Suppl):S65-6. — View Citation

Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. — View Citation

Ferrando AA, Paddon-Jones D, Wolfe RR. Bed rest and myopathies. Curr Opin Clin Nutr Metab Care. 2006 Jul;9(4):410-5. Review. — View Citation

General Principles of Exercise Prescription, in ACSM's Guidelines for Exercise Testing and Prescription, B.A. Franklin, Editor 2006, Lippincott Williams & Wilkins: Philadelphia.

Greenleaf JE, Reese RD. Exercise thermoregulation after 14 days of bed rest. J Appl Physiol Respir Environ Exerc Physiol. 1980 Jan;48(1):72-8. — View Citation

Greenleaf JE, Van Beaumont W, Convertino VA, Starr JC. Handgrip and general muscular strength and endurance during prolonged bedrest with isometric and isotonic leg exercise training. Aviat Space Environ Med. 1983 Aug;54(8):696-700. — View Citation

Greenleaf JE, Wade CE, Leftheriotis G. Orthostatic responses following 30-day bed rest deconditioning with isotonic and isokinetic exercise training. Aviat Space Environ Med. 1989 Jun;60(6):537-42. — View Citation

Grube BJ, Engrav LH, Heimbach DM. Early ambulation and discharge in 100 patients with burns of the foot treated by grafts. J Trauma. 1992 Nov;33(5):662-4. — View Citation

Hart DW, Wolf SE, Mlcak R, Chinkes DL, Ramzy PI, Obeng MK, Ferrando AA, Wolfe RR, Herndon DN. Persistence of muscle catabolism after severe burn. Surgery. 2000 Aug;128(2):312-9. — View Citation

Herndon DN, Hart DW, Wolf SE, Chinkes DL, Wolfe RR. Reversal of catabolism by beta-blockade after severe burns. N Engl J Med. 2001 Oct 25;345(17):1223-9. — View Citation

Hung J, Goldwater D, Convertino VA, McKillop JH, Goris ML, DeBusk RF. Mechanisms for decreased exercise capacity after bed rest in normal middle-aged men. Am J Cardiol. 1983 Jan 15;51(2):344-8. — View Citation

Kildal M, Andersson G, Fugl-Meyer AR, Lannerstam K, Gerdin B. Development of a brief version of the Burn Specific Health Scale (BSHS-B). J Trauma. 2001 Oct;51(4):740-6. — View Citation

Kress JP. Clinical trials of early mobilization of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S442-7. doi: 10.1097/CCM.0b013e3181b6f9c0. Review. — View Citation

LeBlanc A, Gogia P, Schneider V, Krebs J, Schonfeld E, Evans H. Calf muscle area and strength changes after five weeks of horizontal bed rest. Am J Sports Med. 1988 Nov-Dec;16(6):624-9. — View Citation

Levine DS, Greenleaf JE. Immunosuppression during spaceflight deconditioning. Aviat Space Environ Med. 1998 Feb;69(2):172-7. Review. — View Citation

Miller PB, Johnson RL, Lamb LE. Effects of moderate physical exercise during four weeks of bed rest on circulatory functions in man. Aerosp Med. 1965 Nov;36(11):1077-82. — View Citation

Natelson BH, Deroshia C, Adamus J, Finnegan MB, Levin BE. Relations between visceral and behavioral function in men at bedrest. Pavlov J Biol Sci. 1983 Jul-Sep;18(3):161-8. — View Citation

Przkora R, Herndon DN, Suman OE. The effects of oxandrolone and exercise on muscle mass and function in children with severe burns. Pediatrics. 2007 Jan;119(1):e109-16. Epub 2006 Nov 27. — View Citation

Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory dist — View Citation

Stiller K. Physiotherapy in intensive care: an updated systematic review. Chest. 2013 Sep;144(3):825-847. doi: 10.1378/chest.12-2930. Review. — View Citation

Stremel RW, Convertino VA, Bernauer EM, Greenleaf JE. Cardiorespiratory deconditioning with static and dynamic leg exercise during bed rest. J Appl Physiol. 1976 Dec;41(6):905-9. — View Citation

Suman OE, Spies RJ, Celis MM, Mlcak RP, Herndon DN. Effects of a 12-wk resistance exercise program on skeletal muscle strength in children with burn injuries. J Appl Physiol (1985). 2001 Sep;91(3):1168-75. — View Citation

Tipton CM, Greenleaf JE, Jackson CG. Neuroendocrine and immune system responses with spaceflights. Med Sci Sports Exerc. 1996 Aug;28(8):988-98. Review. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary change in lean muscle mass Kilograms It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
Secondary change in VO2 max The maximal amount of oxygen per kilogram of body mass per minute(ml/kg/min) in a cardiopulmonary exercise test. It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.]
Secondary change in distance walked over 6 minutes 6 min walk test measures distance will be recorded in feet. It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
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