- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04755296
Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients
February 10, 2021 updated by: Noha Mohamed Kamel, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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).
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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 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.
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).
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ACTIVE_COMPARATOR: Control group (aerobic exercises group)
They received aerobic exercises 3 times weekly for 12 weeks.In addition to the same traditional physical therapy program.
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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.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic capacity was assessed by measuring maximum oxygen consumption (VO2max)
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to exhaustion (Treadmill time)
Time Frame: 12 weeks
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Time to exhaustion (Treadmill time) was measured by calculating the maximum time that the patient could walk on the treadmill.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: N M Kamel, PhD, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2020
Primary Completion (ACTUAL)
November 30, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
February 6, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (ACTUAL)
February 16, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 16, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Aerobic capacity in burns
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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