Effect of Phototherapy With Exercise on Coagulation in Elderly

Obesity Clinical Trial

Official title:

Influence of Exercise Training Combined With Laser Phototherapy on Coagulation Profile in Senior Individuals With Obesity: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503317
• Other study ID #: P.T.REC/012/002724
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: May 6, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 6, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• • aged from 60 to 75 y

• • sedentary individuals

• Body mass index 30-39.9 kg/m2

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Hypercoagulability
• Obesity
• Thrombophilia

Intervention

Device:
• active acupuncture low level laser in addition to nasal laser irradiation
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

Other:
• treadmill exercise
aerobic exercise once per day, 3 times per week for three months

Locations

Country	Name	City	State
Egypt	Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fibrinogen	measuring by blood analysis change of fibrinogen	12 weeks
Primary	Prothrombin time and partial thromboplastin time	change of Prothrombin time and partial thromboplastin time by blood analysis	12 weeks
Primary	total cholesterol	change of total cholesterol by blood analysis	12 weeks
Primary	d-dimer	change of d-dimer by blood analysis	12 weeks
Primary	c-reactive protein	change of c-reactive protein by blood analysis	12 weeks
Secondary	body mass index	measuring the participants' weights (in kilogram) and heights (in meter)	12 weeks
Secondary	Waist-Hip ratio	It is measured by dividing the participants' circumferences of their waists and hips	12 weeks