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

NCT ID: NCT04755296

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-12-31

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low level laser therapy and aerobic exercises group

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).

Group Type: EXPERIMENTAL

Low level laser therapy

Intervention Type: 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.

Aerobic exercises

Intervention Type: 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.

Traditional physical therapy program

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Aerobic exercises

Intervention Type: 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.

Traditional physical therapy program

Intervention Type: 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).

Interventions

Low level laser therapy

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.

Intervention Type: DEVICE

Aerobic exercises

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.

Intervention Type: OTHER

Traditional physical therapy program

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Noha Mohamed Kamel

lecturer at Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

N M Kamel, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 22342175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21739259 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29185134 (View on PubMed)

Other Identifiers

Aerobic capacity in burns

Identifier Type: -

Identifier Source: org_study_id