Effect of Phototherapy With Exercise on Coagulation in Elderly
Condition: Hypercoagulability; Obesity
MeSH terms: Thrombophilia; Obesity
Study type: Interventional

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
    

Intervention name(s): active acupuncture low level laser in addition to nasal laser irradiation; treadmill exercise
Intervention type(s): Device; Other
Intervention description(s): 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; aerobic exercise once per day, 3 times per week for three months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care