Aerobic Exercises Versus Laser Puncture on Immune Response Following Neck Lymph Node Dissection

NCT06762886 | Completed

• 1 other identifier: P.T.REC/012/004069
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Group (1): Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment. Group (2): Twenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment

Conditions

Neck Lymph Node Dissection; Immune Defects

Keywords

Aerobic Exercises; Laser Puncture Therapy

Outcome Measures

Primary Outcomes (1)

• Leukocyte total count and differential lymphocyte count measurements

  Measurement of immune response: The cases were seated when immune response was measured. Morning peripheral blood sample aspiration was followed by venous blood collection into sterile glass containers with the necessary anticoagulants and preservatives. A Coulter hematology analyzer (Coulter Electronics, USA) was used to perform differential counts of lymphocytes and the total leukocyte count.

  2 months

Study Arms (2)

Cycle ergometer treatment protocol (Group 1):

EXPERIMENTAL

Twenty cases with decreased white blood cell counts after neck lymph nodes and deficient in blood immunological functions made up this group. They underwent aerobic exercise training on a cycle ergometer. The cases received one 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment

Device: Cycle ergometer

Low-level laser treatment protocol (Group 2):

EXPERIMENTAL

Twenty cases with underdeveloped blood immune systems; decreased white blood cell counts after having their neck lymph nodes removed, a low-level laser puncture was performed on the Governing Vessel 14 acupuncture point. They received a 15-minute session, three sessions per week, for two months, with follow-up after the course of treatment

Device: Low-level laser therapy

Interventions

Cycle ergometer DEVICE

The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each.

Cycle ergometer treatment protocol (Group 1):

Low-level laser therapy DEVICE

The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following settings were used for applying laser puncture: 5 mW, the maximum average power. Type of laser: gallium arsenide (Ga-As), 904 nm wavelength, 5 kHz maximum repetition rate - Program: Maintaining programs for people who had their neck lymph nodes removed and have a low leukocyte count, up to 30 J/cm2 of energy, a 2 J/cm2 energy density, and protective glasses were required to prevent irreversible eye injury from either direct or indirect laser exposure. The treatment took place for 15 minutes.

Low-level laser treatment protocol (Group 2):

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All cases were checked carefully by a physician before the study procedures. All cases were approximately the same age.
• All cases were conscious. All cases in both groups obtained the same medications and they received three sessions per week for 2 months.
• All patients enrolled in the study had a deficiency in blood immune functions post neck lymph node dissection and received chemotherapy.

You may not qualify if:

• Patients with associated disease (other pathological conditions). patients suffering from metastases. patients taking medications that alter leukocytes count and pregnancy or epilepsy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Cycle ergometer treatment protocol (Group 1): The case was lying back in a comfortable position on the stationary bike ergometer when the exercise test was conducted. The exercise test began with a 3-minute warm-up session of unloaded cycling on a cycle ergometer, and then progressed at a rate of 10 W per minute up to the subject's threshold. After cycling for 30 W to warm up, the intensity was raised by 15 W every 60 seconds until fatigue, after which the individuals cycled for 30 W to cool down. This treatment protocol was administered to each patient 3 times/week for a total of 15 minutes of treatment, broken into intervals of two to three minutes each. Low-level laser treatment protocol (Group 2): The laser probe was administered using the contact approach on the dorsal midline, in the depression below the spinous process of C7 at Governor Vessel, with the patient seated in a chair with back support (GV - 14 Dazhui). The primary power switch was activated. The following set

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: October 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: February 15, 2023
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

EG (1)