BurnsNCT04755296
Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients
A study testing Low level laser therapy, Aerobic exercises and Traditional physical therapy program in people with Burns, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Burns
- What is being tested?
- Low level laser therapy, Aerobic exercises and Traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Low level laser therapy, Aerobic exercises, Traditional physical therapy program
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
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 exercisesOther
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 programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Aerobic exercises; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Time to exhaustion (Treadmill time)
Time to exhaustion (Treadmill time) was measured by calculating the maximum time that the patient could walk on the treadmill.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 May 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed Kamel, Cairo University
- Investigators
- N M Kamel, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755296
- Sponsor's protocol ID
- Aerobic capacity in burns
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22342175De 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.
PubMed 21739259Miranda 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.
PubMed 29185134
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Aerobic Capacity to Low Level Laser Therapy in Burned Patients
- ClinicalTrials.gov ID
- NCT04755296
- Acronym / sponsor ID
- Aerobic capacity in burns
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy and aerobic exercises group | Experimental | Device: Low level laser therapy, Other: Aerobic exercises, Other: Traditional physical therapy programThey 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). |
| Control group (aerobic exercises group) | Active comparator | Other: Aerobic exercises, Other: Traditional physical therapy programThey received aerobic exercises 3 times weekly for 12 weeks.In addition to the same traditional physical therapy program. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sixty adult burned patients were selected under the following criteria:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level laser therapyLow 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. | Device | Low level laser therapy and aerobic exercises group |
| Aerobic exercisesAerobic 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. | Other | Control group (aerobic exercises group), Low level laser therapy and aerobic exercises group |
| Traditional physical therapy programPatients 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). | Other | Control group (aerobic exercises group), Low level laser therapy and aerobic exercises group |
Primary outcome
Aerobic capacity was assessed by measuring maximum oxygen consumption (VO2max)
Time frame: 12 weeks
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.
1 secondary outcome
Time to exhaustion (Treadmill time)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 22342175Grisbrook 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.
- Background: PubMed 21739259De 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.
- Background: PubMed 29185134Miranda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
N M Kamel, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy, Aerobic exercises and Traditional physical therapy program in people with Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity was assessed by measuring maximum oxygen consumption (VO2max) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755296, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.