Clinical trial NCT04755296: Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients
Official title: Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe burns can decrease pulmonary function and impair aerobic capacity persisting for long times post injury. Low level laser therapy is a new modality used to improve aerobic capacity, enhance exercise performance, increase time until fatigue when used prior to aerobic exercises. This study aimed to evaluate the effects of pre- exercise low level laser therapy on aerobic capacity in burned patients.

Detailed description: Low level laser therapy has a beneficial therapeutic effect on promoting aerobic capacity, improving maximum oxygen consumption and increasing treadmill time when preceding aerobic exercise training.This study was conducted to determine the effects of pre- exercise low level laser therapy on aerobic capacity in burned patients. Low level laser therapy was applied to the study group for 12 weeks before aerobic exercises, three sessions / week, while control group received 12 weeks of aerobic exercises, three times weekly. Patients in both groups were received the traditional physical therapy program as a routine treatment. Aerobic capacity was assessed by measuring maximum oxygen consumption and time to exhaustion at baseline and after twelve weeks of interventions for both groups.

Eligibility criteria: Inclusion Criteria:

* Sixty adult burned patients were selected under the following criteria:

  * Patients were both males and females.
  * Their age ranged from (25-40) years.
  * Patients suffered from second degree thermal burns with total body surface area(TBSA) for burns ranged from 20-40%.
  * Patients were participated in this study one month after their hospital discharge.

Exclusion Criteria:

* Cardiopulmonary diseases.
* Any limitation in range of motion (ROM) of joints of the lower limbs which may prevent adequate participation in aerobic exercise program.
* Leg amputation.
* Quadriplegia.
* Psychological illness or severe behavior or cognitive disorders.
* Patients who participated in any rehabilitation program before the study that may affect the results of the study.

Primary outcomes:
measure: Aerobic capacity was assessed by measuring maximum oxygen consumption (VO2max)
timeFrame: 12 weeks
Secondary outcomes:
measure: Time to exhaustion (Treadmill time)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: N M Kamel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grisbrook TL, Wallman KE, Elliott CM, Wood FM, Edgar DW, Reid SL. The effect of exercise training on pulmonary function and aerobic capacity in adults with burn. Burns. 2012 Jun;38(4):607-13. doi: 10.1016/j.burns.2011.11.004. Epub 2012 Feb 16.
citation: De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.
citation: Miranda EF, Tomazoni SS, de Paiva PRV, Pinto HD, Smith D, Santos LA, de Tarso Camillo de Carvalho P, Leal-Junior ECP. When is the best moment to apply photobiomodulation therapy (PBMT) when associated to a treadmill endurance-training program? A randomized, triple-blinded, placebo-controlled clinical trial. Lasers Med Sci. 2018 May;33(4):719-727. doi: 10.1007/s10103-017-2396-2. Epub 2017 Nov 29.