Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients

NCT04755296 | Completed

• 1 other identifier: Aerobic capacity in burns
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Aerobic capacity was assessed by measuring maximum oxygen consumption (VO2max)

  Aerobic capacity was evaluated by measuring VO2max during a Graded Exercise Test (GXT) performed on a treadmill using the modified Bruce protocol before the treatment and after 12 weeks of treatment for both groups.The Bruce protocol required subjects to walk at progressively higher workloads, with the treadmill speed and the inclination were increased incrementally every 3 minutes until it was no longer possible for the participant to continue. During GXT, participants breathed through a face mask which was linked to a calibrated expired gas analysis system (UltimaTM Series, Cardiorespiratory Diagnostic systems),MED GRAPHICSTM, St. Paul, Minnesota ,USA. Expired gas passed through a flowmeter, oxygen and carbon dioxide analyzers which were connected to a computer, which measured oxygen uptake.The sum of the 4 highest successive 15 s VO2 values was recorded as VO2max of the participants.

  12 weeks

Secondary Outcomes (1)

• Time to exhaustion (Treadmill time)

  12 weeks

Study Arms (2)

Low level laser therapy and aerobic exercises group

EXPERIMENTAL

They received low level laser therapy and aerobic exercises using a treadmill, 3 sessions per week for 12 weeks.In addition to traditional physical therapy program in the form of (stretching and strengthening exercises for all affected areas, diaphragmatic breathing exercises and activities of daily living).

Device: Low level laser therapy; Other: Aerobic exercises; Other: Traditional physical therapy program

Control group (aerobic exercises group)

ACTIVE COMPARATOR

They received aerobic exercises 3 times weekly for 12 weeks.In addition to the same traditional physical therapy program.

Other: Aerobic exercises; Other: Traditional physical therapy program

Interventions

Low level laser therapy DEVICE

Low level laser therapy was applied immediately before each aerobic exercise training session by using a multidiode cluster (with four diode spots; Polaris2, manufactured by Astar ABR, Poland) )on 12 sites on the lower limb (6 on quadriceps ( 2 centrally on rectus femoris and vastus intermedius,2 laterally on vastus lateralis, and two medially on vastus medialis), 4 on hamstrings and 2 on gastrocnemius) with the following parameters: 808 nm, continous output, 200 mW each diode (total of 800 mW) power output, 24 J energy on each site (6 J for each spot) , 40 seconds at each site (8 minutes of total treatment time in lower limb) and 288 J total energy delivered per lower limb, 48 irradiation points per lower limb ,3 sessions weekly for 12 weeks.

Low level laser therapy and aerobic exercises group

Aerobic exercises OTHER

Aerobic exercise program consisted of walking on the treadmill at a rate of 3 sessions/week for 12 weeks, with each session lasting for 40 minutes in the form of warming up for 5 minutes at intensity of \<50% of the previously determined VO2max of each participant, 30 minutes of treadmill exercises at intensity of (70-85%) of the previously determined VO2max of each participant then 5 minutes cooling down at intensity of\<50% of the previously determined VO2max of each participant.

Control group (aerobic exercises group); Low level laser therapy and aerobic exercises group

Traditional physical therapy program OTHER

Patients were received traditional physical therapy program in the form of (stretching and strengthening exercises for all affected areas, diaphragmatic breathing exercises and activities of daily living).

Control group (aerobic exercises group); Low level laser therapy and aerobic exercises group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (3)

• 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.

  PMID: 22342175 BACKGROUND

• 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.

  PMID: 21739259 BACKGROUND

• 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.

  PMID: 29185134 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Low-Level Light Therapy; Exercise

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• N M Kamel, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 16, 2021
• Study Start: May 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

EG (1)