Diabetes Mellitus Non-insulin-dependentNCT01925443
Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II
A study testing Low level laser therapy in people with Diabetes Mellitus Non-insulin-dependent, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy) isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular work , maximum power and fatigue index - normalized… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus Non-insulin-dependent
- What is being tested?
- Low level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to Jun 2017
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis for Diabetes mellitus non-insulin-dependent
- Age between 30 to 70 years
Who cannot join
- Diagnosis of cardiovascular disorders
- Diagnosis of diabetic neuropathy,
- Skin lesion or local infection (quadriceps)
- History of musculoskeletal injuries in the last 6 months or during the study
- Individuals unable to perform the assessment protocols or exercise
- Regular physical activity
- Underwent alcohol intake in the 24 hours before any of the stages of the study
Trial locations and contacts
1 site in 1 country.
About this study
The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy) isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric isokinetic quadriceps femoris muscle in subjects with diabetes mellitus non-insulin-dependent.
Read the detailed description
The low level laser therapy is able to improve after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy, the indicators: The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy), the indirect blood markers for muscle damage that evaluate the enzymatic activity of creatine Kinase (CK) and Lactate Dehydrogenase (LDH) and the visual analog scale (VAS-F) for fatigue, improves indicators F 2.2 point of the WHOQOL-100 for fatigue, improvement in functional indicators of the lower lower Extremity functional regarding Scale, functional improvement in performance in the execution of the test stand and sit and walk test six minutes, the indicators for quality improvement of life questionnaire for the Diabetes Quality of Life Measure and emotional states through the questionnaire Problems Areas in Diabetes Scale. Eligibility criteria: Diagnosis for Diabetes mellitus non-insulin-dependent confirmed by the individual physician, presenting between 30 to 70 years.Exclusion criteria: Diagnosis of cardiovascular disorders, diagnosis of diabetic neuropathy, which have a skin lesion or local infection (quadriceps), history of musculoskeletal injuries in the last 6 months or during the study, individuals unable to perform the assessment protocols / exercise so satisfactory, those who are doing some kind of regular physical activity and who underwent alcohol intake in the 24 hours before any of the stages of the study.
- Conditions
- Diabetes Mellitus Non-insulin-dependent
- Being tested
- Low level laser therapy
- Keywords
- diabetes mellitus non-insulin-dependent, low level laser therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyOther
Will be performed irradiation with low-intensity laser in quadriceps muscle
| Study group | Role | What they receive |
|---|---|---|
| low level laser therapy | Experimental | individuals will be subject to the application of low level laser therapy, but this group will have three subdivisions related to dose in joules that will be administered to the individual, and J 4, J 6, 8 J. To be administered in the quadriceps muscle. Receives: Other: Low level laser therapy |
| Control Group | No intervention | will consist of individuals diagnosed with diabetes mellitus non-insulin-dependent, however, will not perform low level laser therapy, participate only in the evaluations |
| Placebo group | Experimental | individuals will be subject to the application of low level laser therapy but with a dose of 0 Joules. Receives: Other: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function
Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps.
Measured: 2 Years
Secondary outcomes (4)
Muscle damage
Will be evaluated blood markers (creatine kinase and lactate dehydrogenase) as indirect markers of muscle damage by spectrophotometry using kits specific reagents.
Measured: 2 year
Muscle fatigue
In order to assess self-perceived fatigue in day-to-day and immediately after the fatigue protocol will be used two instruments: a visual analog scale (VAS-F) and the question of F2.2 instrument for assessing quality of life World Health Organization (WHOQOL-100).
Measured: 2 years
Functionality
Functionality will be evaluated using the following assessment tools: Stand and sit test, Six-minute walk test, and Lower Extremity Functional Scale.
Measured: 2 years
Quality of life
The quality of life will be assessed by the questionnaire "Diabetes Quality of Life Measure"
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: technical problems with equipment from the main outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Non-insulin-dependentStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
- Investigators
- Cid Gomes, MSc, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925443
- Sponsor's protocol ID
- U1111-1146-7109
- Status last verified
- Dec 2015
- First submitted
- 8 Jun 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT01925443
- Acronym / sponsor ID
- U1111-1146-7109
- Conditions
- Diabetes Mellitus Non-insulin-dependent
- Keywords
- diabetes mellitus non-insulin-dependent, low level laser therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: technical problems with equipment from the main outcome
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Aug 2013 (estimated)
- 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.
The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy) isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric isokinetic quadriceps femoris muscle in subjects with diabetes mellitus non-insulin-dependent.
Detailed description
The low level laser therapy is able to improve after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy, the indicators: The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy), the indirect blood markers for muscle damage that evaluate the enzymatic activity of creatine Kinase (CK) and Lactate Dehydrogenase (LDH) and the visual analog scale (VAS-F) for fatigue, improves indicators F 2.2 point of the WHOQOL-100 for fatigue, improvement in functional indicators of the lower lower Extremity functional regarding Scale, functional improvement in performance in the execution of the test stand and sit and walk test six minutes, the indicators for quality improvement of life questionnaire for the Diabetes Quality of Life Measure and emotional states through the questionnaire Problems Areas in Diabetes Scale. Eligibility criteria: Diagnosis for Diabetes mellitus non-insulin-dependent confirmed by the individual physician, presenting between 30 to 70 years.Exclusion criteria: Diagnosis of cardiovascular disorders, diagnosis of diabetic neuropathy, which have a skin lesion or local infection (quadriceps), history of musculoskeletal injuries in the last 6 months or during the study, individuals unable to perform the assessment protocols / exercise so satisfactory, those who are doing some kind of regular physical activity and who underwent alcohol intake in the 24 hours before any of the stages of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low level laser therapy | Experimental | Other: Low level laser therapyindividuals will be subject to the application of low level laser therapy, but this group will have three subdivisions related to dose in joules that will be administered to the individual, and J 4, J 6, 8 J. To be administered in the quadriceps muscle. |
| Control Group | No intervention | –will consist of individuals diagnosed with diabetes mellitus non-insulin-dependent, however, will not perform low level laser therapy, participate only in the evaluations |
| Placebo group | Experimental | Other: Low level laser therapyindividuals will be subject to the application of low level laser therapy but with a dose of 0 Joules. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis for Diabetes mellitus non-insulin-dependent
- Age between 30 to 70 years
Key exclusion criteria (7 listed)
- Diagnosis of cardiovascular disorders
- Diagnosis of diabetic neuropathy,
- Skin lesion or local infection (quadriceps)
- History of musculoskeletal injuries in the last 6 months or during the study
- Individuals unable to perform the assessment protocols or exercise
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 therapyWill be performed irradiation with low-intensity laser in quadriceps muscle | Other | Placebo group, low level laser therapy |
Primary outcome
Muscle function
Time frame: 2 Years
Will use the isokinetic dynamometer to test and evaluate the human musculoskeletal system: peak torque and muscle fatigue of quadriceps.
4 secondary outcomes
Muscle damage
Time frame: 2 year
Muscle fatigue
Time frame: 2 years
Functionality
Time frame: 2 years
Quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Related InfoLink provided by the sponsor.
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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.
Cid Gomes, MSc principal investigator
University of Nove de Julho
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 in people with Diabetes Mellitus Non-insulin-dependent, run by University of Nove de Julho at 1 site in Brazil.
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 2 inclusion and 7 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: paused, as of the sponsor's last update on 3 Dec 2015. 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 Brazil. 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?
Results are not available in the source record.
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?
Muscle function (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.