HypercoagulabilityNCT04503317
Effect of Phototherapy With Exercise on Coagulation in Elderly
A study testing active acupuncture low level laser in addition to nasal laser irradiation and treadmill exercise in people with Hypercoagulability and Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
It is an interventional study in which 60 obese elderly patients (30 male \& 30 female) estimated to enroll according to random allocation and divided into two groups. The study group will receive active acupuncture low level laser in addition to nasal laser irradiation and aerobic exercises while the control group… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hypercoagulability, Obesity
- What is being tested?
- active acupuncture low level laser in addition to nasal laser irradiation and treadmill exercise
- 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
- 10 Sep 2020to 6 May 2023
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • aged from 60 to 75 y
- • sedentary individuals
- Body mass index 30-39.9 kg/m2
Who cannot join
- • The exclusion criteria were as follows: smokers, diabetes, drinking alcohol, presence of uncontrolled hypertension or cardiovascular diseases, weight loss program participation for at least 6 months prior to the current study, medications affecting blood coagulation or body weight, recent or chronic active disease, cognitive impairment, presence of malignant disease, blood donation, or participation in any other research during the previous 90 days of the current study Individuals suffering from hepatic, renal, cardiac, chest, and endocrine diseases, as well as musculoskeletal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Exercise Training Combined With Laser Phototherapy on Coagulation Profile in Senior Individuals With Obesity: A Randomized Clinical Trial
It is an interventional study in which 60 obese elderly patients (30 male \& 30 female) estimated to enroll according to random allocation and divided into two groups. The study group will receive active acupuncture low level laser in addition to nasal laser irradiation and aerobic exercises while the control group will aerobic exercises. The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months
Read the detailed description
PURPOSE:
To determine whether low level laser light therapy is effective as an adjunctive therapy on countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as preventive strategy of venous thromboembolism incidence in obese elderly patients
BACKGROUND:
In the general population the annual incidence of venous thrombosis (VT) approximates 1 in 1000 persons and appears to be increasing over time. Notably, incidence rates rise exponentially with age with an approximate 7- to 10-fold increase from less than 55 years to greater than 75 years. Aging is associated with increased levels of coagulation factors and decrease in natural anticoagulant factors. This strongly supports that age-related hypercoagulable state occurs in elderly.
Blood coagulation plays a critical role not only in homeostasis but also in many physiological and pathological conditions. Blood coagulation potential in humans reaches a young adult level around the time of weaning, followed by a gradual increase during young adulthood and an almost 2-fold increase by old age.
Fibrinogen may contribute to the cardiovascular risk due to their influence on blood viscosity, platelet aggregation, low-density lipoprotein deposition, blood vessel diameter and cell proliferation. Most of the factors that cause venous thromboembolism are related to changes in blood flow and changes in the composition of the blood.
In recent years, an innovative technology using low-level laser light has garnered an exceptional level of interest across myriad medical disciplines because of its unique ability to modulate cellular metabolism, therefore inducing beneficial clinical effects
Low level laser radiation has particular effect on blood viscosity by changing the sizes of erythrocyte aggregates which lead to an increase in the blood flow velocity in the human body. There are several reasons for the increase in the blood microcirculation under irradiation. One of the major reasons is the activation of the respiratory chains of cells leading to a cascade of biochemical reactions that resulting in an increase in the permeability of erythrocyte membranes and an increase in the concentration of oxygen in the bio tissues.
HYPOTHESES:
countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as a preventive strategy of venous thromboembolism incidence in obese elderly patients
RESEARCH QUESTION:
Does low level laser therapy with aerobic exercises influence on obese elderly patients' hemostatic state parameters as coagulation profile ((fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as prevention of venous thromboembolism in the obese elderly patient
- Conditions
- Hypercoagulability, Obesity
- Being tested
- active acupuncture low level laser in addition to nasal laser irradiation, treadmill exercise
- Medical subject headings
- Thrombophilia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active acupuncture low level laser in addition to nasal laser irradiationDevice
laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time with treadmill aerobic exercise, once per day, 3 times per week for three months
treadmill exerciseOther
aerobic exercise once per day, 3 times per week for three months
| Study group | Role | What they receive |
|---|---|---|
| active acupuncture low level laser and aerobic exercise | Experimental | active acupuncture, low level laser and aerobic exercise Receives: Device: active acupuncture low level laser in addition to nasal laser irradiation; Other: treadmill exercise |
| aerobic exercise | Active comparator | aerobic exercise Receives: Other: treadmill exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrinogen
measuring by blood analysis change of fibrinogen
Measured: 12 weeks
Prothrombin time and partial thromboplastin time
change of Prothrombin time and partial thromboplastin time by blood analysis
Measured: 12 weeks
total cholesterol
change of total cholesterol by blood analysis
Measured: 12 weeks
d-dimer
change of d-dimer by blood analysis
Measured: 12 weeks
c-reactive protein
change of c-reactive protein by blood analysis
Measured: 12 weeks
Secondary outcomes (2)
body mass index
measuring the participants' weights (in kilogram) and heights (in meter)
Measured: 12 weeks
Waist-Hip ratio
It is measured by dividing the participants' circumferences of their waists and hips
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 posted7 Aug 2020
- Study start10 Sep 2020
- Primary completion30 Dec 2022
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercoagulabilityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
- Investigators
- marwa m elsayed, phd, Principal investigator, physical therapy faculty Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503317
- Sponsor's protocol ID
- P.T.REC/012/002724
- Status last verified
- May 2023
- First submitted
- 26 Jul 2020
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Elsayed MM, Abdallah GA, Hassan SS, Nagy EN. Effect of exercise training with laser phototherapy on homeostasis balance resistant to hypercoagulability in seniors with obesity: a randomized trial. Sci Rep. 2023 Mar 3;13(1):3592. doi: 10.1038/s41598-023-30550-x.
PubMed 36869148
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise Training Combined With Laser Phototherapy on Coagulation Profile in Senior Individuals With Obesity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04503317
- Acronym / sponsor ID
- P.T.REC/012/002724
- Conditions
- Hypercoagulability, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 7 Aug 2020 (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.
It is an interventional study in which 60 obese elderly patients (30 male \& 30 female) estimated to enroll according to random allocation and divided into two groups. The study group will receive active acupuncture low level laser in addition to nasal laser irradiation and aerobic exercises while the control group will aerobic exercises. The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months
Detailed description
PURPOSE:
To determine whether low level laser light therapy is effective as an adjunctive therapy on countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as preventive strategy of venous thromboembolism incidence in obese elderly patients
BACKGROUND:
In the general population the annual incidence of venous thrombosis (VT) approximates 1 in 1000 persons and appears to be increasing over time. Notably, incidence rates rise exponentially with age with an approximate 7- to 10-fold increase from less than 55 years to greater than 75 years. Aging is associated with increased levels of coagulation factors and decrease in natural anticoagulant factors. This strongly supports that age-related hypercoagulable state occurs in elderly.
Blood coagulation plays a critical role not only in homeostasis but also in many physiological and pathological conditions. Blood coagulation potential in humans reaches a young adult level around the time of weaning, followed by a gradual increase during young adulthood and an almost 2-fold increase by old age.
Fibrinogen may contribute to the cardiovascular risk due to their influence on blood viscosity, platelet aggregation, low-density lipoprotein deposition, blood vessel diameter and cell proliferation. Most of the factors that cause venous thromboembolism are related to changes in blood flow and changes in the composition of the blood.
In recent years, an innovative technology using low-level laser light has garnered an exceptional level of interest across myriad medical disciplines because of its unique ability to modulate cellular metabolism, therefore inducing beneficial clinical effects
Low level laser radiation has particular effect on blood viscosity by changing the sizes of erythrocyte aggregates which lead to an increase in the blood flow velocity in the human body. There are several reasons for the increase in the blood microcirculation under irradiation. One of the major reasons is the activation of the respiratory chains of cells leading to a cascade of biochemical reactions that resulting in an increase in the permeability of erythrocyte membranes and an increase in the concentration of oxygen in the bio tissues.
HYPOTHESES:
countering hypercoagulable state parameters (fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as a preventive strategy of venous thromboembolism incidence in obese elderly patients
RESEARCH QUESTION:
Does low level laser therapy with aerobic exercises influence on obese elderly patients' hemostatic state parameters as coagulation profile ((fibrinogen, bleeding time, Prothrombin time) and total cholesterol (, d-dimer and c-reactive protein) as prevention of venous thromboembolism in the obese elderly patient
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active acupuncture low level laser and aerobic exercise | Experimental | Device: active acupuncture low level laser in addition to nasal laser irradiation, Other: treadmill exerciseactive acupuncture, low level laser and aerobic exercise |
| aerobic exercise | Active comparator | Other: treadmill exerciseaerobic exercise |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • aged from 60 to 75 y
Key exclusion criteria (1 listed)
- • The exclusion criteria were as follows: smokers, diabetes, drinking alcohol, presence of uncontrolled hypertension or cardiovascular diseases, weight loss program participation for at least 6 months prior to the current study, medications affecting blood coagulation or body weight, recent or chronic active disease, cognitive impairment, presence of malignant disease, blood donation, or participation in any other research during the previous 90 days of the current study Individuals suffering from hepatic, renal, cardiac, chest, and endocrine diseases, as well as musculoskeletal disease
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 |
|---|---|---|
| active acupuncture low level laser in addition to nasal laser irradiationlaser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time with treadmill aerobic exercise, once per day, 3 times per week for three months | Device | active acupuncture low level laser and aerobic exercise |
| treadmill exerciseaerobic exercise once per day, 3 times per week for three months | Other | active acupuncture low level laser and aerobic exercise, aerobic exercise |
Primary outcome
fibrinogen
Time frame: 12 weeks
measuring by blood analysis change of fibrinogen
Prothrombin time and partial thromboplastin time
Time frame: 12 weeks
change of Prothrombin time and partial thromboplastin time by blood analysis
total cholesterol
Time frame: 12 weeks
change of total cholesterol by blood analysis
d-dimer
Time frame: 12 weeks
change of d-dimer by blood analysis
c-reactive protein
Time frame: 12 weeks
change of c-reactive protein by blood analysis
2 secondary outcomes
body mass index
Time frame: 12 weeks
Waist-Hip ratio
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 9 May 2023.
- Derived from this study: PubMed 36869148Elsayed MM, Abdallah GA, Hassan SS, Nagy EN. Effect of exercise training with laser phototherapy on homeostasis balance resistant to hypercoagulability in seniors with obesity: a randomized trial. Sci Rep. 2023 Mar 3;13(1):3592. doi: 10.1038/s41598-023-30550-x.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
marwa m elsayed, phd principal investigator
physical therapy faculty 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 active acupuncture low level laser in addition to nasal laser irradiation and treadmill exercise in people with Hypercoagulability and Obesity, 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 3 inclusion and 1 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 9 May 2023. 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?
fibrinogen (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT04503317, which also lists 1 linked publication.
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 9 May 2023.