Effect of Phototherapy With Exercise on Coagulation in Elderly

NCT04503317 | Completed

• 1 other identifier: P.T.REC/012/002724
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hypercoagulability; Obesity

Outcome Measures

Primary Outcomes (5)

• fibrinogen

  measuring by blood analysis change of fibrinogen

  12 weeks

• Prothrombin time and partial thromboplastin time

  change of Prothrombin time and partial thromboplastin time by blood analysis

  12 weeks

• total cholesterol

  change of total cholesterol by blood analysis

  12 weeks

• d-dimer

  change of d-dimer by blood analysis

  12 weeks

• c-reactive protein

  change of c-reactive protein by blood analysis

  12 weeks

Secondary Outcomes (2)

• body mass index

  12 weeks

• Waist-Hip ratio

  12 weeks

Study Arms (2)

active acupuncture low level laser and aerobic exercise

EXPERIMENTAL

active acupuncture, low level laser and aerobic exercise

Device: active acupuncture low level laser in addition to nasal laser irradiation; Other: treadmill exercise

aerobic exercise

ACTIVE COMPARATOR

aerobic exercise

Other: treadmill exercise

Interventions

active acupuncture low level laser in addition to nasal laser irradiation 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

active acupuncture low level laser and aerobic exercise

treadmill exercise OTHER

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

active acupuncture low level laser and aerobic exercise; aerobic exercise

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged from 60 to 75 y
• sedentary individuals
• Body mass index 30-39.9 kg/m2

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy

Cairo, 11432, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36869148 DERIVED

MeSH Terms

Conditions

Thrombophilia; Obesity

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• marwa m elsayed, phd

  physical therapy faculty Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 7, 2020
• Study Start: September 10, 2020
• Primary Completion: December 30, 2022
• Study Completion: May 6, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after completing the study by one year
• Access Criteria: journal published the study

Locations

EG (1)