Effect of Phototherapy With Exercise on Coagulation in Elderly

NCT ID: NCT04503317

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2023-05-06

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

active acupuncture low level laser and aerobic exercise

active acupuncture, low level laser and aerobic exercise

Group Type: EXPERIMENTAL

active acupuncture low level laser in addition to nasal laser irradiation

Intervention Type: DEVICE

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 exercise

Intervention Type: OTHER

aerobic exercise once per day, 3 times per week for three months

aerobic exercise

aerobic exercise

Group Type: ACTIVE_COMPARATOR

treadmill exercise

Intervention Type: OTHER

aerobic exercise once per day, 3 times per week for three months

Interventions

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

Intervention Type: DEVICE

treadmill exercise

aerobic exercise once per day, 3 times per week for three months

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • aged from 60 to 75 y

• • sedentary individuals
• Body mass index 30-39.9 kg/m2

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa mahmoud elsayed mahmoud

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marwa m elsayed, phd

Role: PRINCIPAL_INVESTIGATOR

physical therapy faculty Cairo university

Locations

Physical Therapy

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 36869148 (View on PubMed)

Other Identifiers

P.T.REC/012/002724

Identifier Type: -

Identifier Source: org_study_id