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Effect of Phototherapy With Exercise on Coagulation in Elderly

Primary Purpose

Hypercoagulability, Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active acupuncture low level laser in addition to nasal laser irradiation
treadmill exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypercoagulability

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

active acupuncture low level laser and aerobic exercise

aerobic exercise

Arm Description

active acupuncture, low level laser and aerobic exercise

aerobic exercise

Outcomes

Primary Outcome Measures

fibrinogen
measuring by blood analysis change of fibrinogen
Prothrombin time and partial thromboplastin time
change of Prothrombin time and partial thromboplastin time by blood analysis
total cholesterol
change of total cholesterol by blood analysis
d-dimer
change of d-dimer by blood analysis
c-reactive protein
change of c-reactive protein by blood analysis

Secondary Outcome Measures

body mass index
measuring the participants' weights (in kilogram) and heights (in meter)
Waist-Hip ratio
It is measured by dividing the participants' circumferences of their waists and hips

Full Information

First Posted
July 26, 2020
Last Updated
May 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04503317
Brief Title
Effect of Phototherapy With Exercise on Coagulation in Elderly
Official Title
Influence of Exercise Training Combined With Laser Phototherapy on Coagulation Profile in Senior Individuals With Obesity: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
May 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercoagulability, Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active acupuncture low level laser and aerobic exercise
Arm Type
Experimental
Arm Description
active acupuncture, low level laser and aerobic exercise
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
aerobic exercise
Intervention Type
Device
Intervention Name(s)
active acupuncture low level laser in addition to nasal laser irradiation
Intervention Description
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
Other
Intervention Name(s)
treadmill exercise
Intervention Description
aerobic exercise once per day, 3 times per week for three months
Primary Outcome Measure Information:
Title
fibrinogen
Description
measuring by blood analysis change of fibrinogen
Time Frame
12 weeks
Title
Prothrombin time and partial thromboplastin time
Description
change of Prothrombin time and partial thromboplastin time by blood analysis
Time Frame
12 weeks
Title
total cholesterol
Description
change of total cholesterol by blood analysis
Time Frame
12 weeks
Title
d-dimer
Description
change of d-dimer by blood analysis
Time Frame
12 weeks
Title
c-reactive protein
Description
change of c-reactive protein by blood analysis
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body mass index
Description
measuring the participants' weights (in kilogram) and heights (in meter)
Time Frame
12 weeks
Title
Waist-Hip ratio
Description
It is measured by dividing the participants' circumferences of their waists and hips
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa m elsayed, phd
Organizational Affiliation
physical therapy faculty Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
after completing the study by one year
IPD Sharing Access Criteria
journal published the study
IPD Sharing URL
http://Scholar.cu.edu.eg/p_t

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Effect of Phototherapy With Exercise on Coagulation in Elderly

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