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Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy

Primary Purpose

Thyroid Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
X-BOX kinetic360
mediterranean diet
thyroid hormone replacement therapy
Sponsored by
Nabil Mahmoud Ismail Abdel-Aal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of thyroid papillary carcinoma as it is the most common type
  2. Treatment with thyroid hormone medication after thyroidectomy
  3. Lack of radioactive iodine treatment within the past 6 months
  4. Blood hemoglobin level >10 g/dL.
  5. Not taking drugs that could affect their immune function (e.g., immunosuppressants such as cyclosporin and steroids .
  6. Lack of regular exercise
  7. Age 18~45 years
  8. Dose should be controlled at the first one year

    -

    Exclusion Criteria:

1) Abscess or inflammation suspected by preoperative tests 2) Patients with stage IV cancer and with limited understanding of assessment systems 3) History of head or neck malignancy . 4) Radiation therapy 5) Graves disease 6) Thyroiditis 7) Orthopaedic and rheumatic conditions of the neck . 8) The patient's inability to cooperate

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy

    Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions

    Group C: Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.

    Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet

    Outcomes

    Primary Outcome Measures

    CD3-
    CD3 (cluster of differentiation 3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell (CD8+ naive T cells) and T helper cells (CD4+ naive T cells). It is composed of four distinct chains. blood sample taken from the patients
    CD16+
    CD16 is involved in antibody-dependent cell-mediated cytotoxicity and is expressed on large granular lymphocytes (LGLs) of both NK- and T-cell types.blood sample taken from the patients
    CD56+
    CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients

    Secondary Outcome Measures

    TSH(thyroid stimulating hormone)
    TSH stands for thyroid stimulating hormone. A TSH test is a blood test that measures this hormone.
    T3 (triiodothyronine)
    This test measures the level of triiodothyronine (T3) in your blood. T3 is one of two major hormones made by your thyroid
    T4 (Thyroxine)
    Thyroxine, also known as T4, is a type of thyroid hormone. This test measures the level of T4 in your blood. Too much or too little T4 can indicate thyroid disease.
    Quality of life questionnaire
    The World Health Organization (WHO) defined Quality of Life (QoL) as "an individual's perception of their position in life, in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns" . QoL is comprised of multiple aspects, including psychological health, physical well-being, social relationships, and environmental conditions [.
    Fatigue questionnaire
    questionnaire is applied to the patients

    Full Information

    First Posted
    February 23, 2022
    Last Updated
    February 23, 2022
    Sponsor
    Nabil Mahmoud Ismail Abdel-Aal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05265819
    Brief Title
    Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy
    Official Title
    Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    December 5, 2022 (Anticipated)
    Study Completion Date
    December 5, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nabil Mahmoud Ismail Abdel-Aal

    4. Oversight

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

    5. Study Description

    Brief Summary
    Effect of exergaming exercises and mediteranean diet on thyroid cancer patients following total thyroidectomy adult patients from both gender will be randomly assigned equally to exergaming exercises, Mediterranean diet groups using computer-generated block randomization. Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
    Detailed Description
    Outcome measures Flow cytometry analyzer for NKC (CD3- CD16+ CD56+). Immunoassay analyzer for thyroid profile (TSH,T3,T4) Quality of life questionnaire Fatigue questionnaire PREDIMED questionnaire to asses diet adherence. Outcome measures will be measured at baseline and after 3 months of the treatement intervention A) assessment Quality of life questionnaire questionnaire .Fatigue questionnaire Adherence to diet A validated 14-item questionnaire for the assessment of adherence to the Mediterranean Diet (PREDIMED) will be recorded for all the enrolled subjects Biochemical Analysis. [B] Intervention Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console (Microsoft, Albuquerque, NM) Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial. 4 groups will be randomly assigned Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed three times a week, for a total of 12 weeks Group C: Mediterranean diet All participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.PREDIMED questionnaire is used To assess adherence to the Mediterranean diet Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Group C: Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
    Intervention Type
    Device
    Intervention Name(s)
    X-BOX kinetic360
    Other Intervention Name(s)
    thyroid hormone replacement therapy
    Intervention Description
    1) Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console,The volunteers carried out 36 exergaming sessions, with progressive increase in the duration of the games according to their tolerance,and reached a maximum duration of 50 minutes per session, included the realization of the games and the rest between activities. The exergaming protocol was performed two to three times a week, for a total of 12 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    mediterranean diet
    Other Intervention Name(s)
    thyroid hormone replacement therapy
    Intervention Description
    Mediterranean diet participants participated in the Mediterranean diet intervention for 12 weak and received dietary training from professional nutritionists at the baseline visit and samples of a Mediterranean diet for three times during the trial.
    Intervention Type
    Drug
    Intervention Name(s)
    thyroid hormone replacement therapy
    Intervention Description
    thyroid hormone replacement therapy
    Primary Outcome Measure Information:
    Title
    CD3-
    Description
    CD3 (cluster of differentiation 3) is a protein complex and T cell co-receptor that is involved in activating both the cytotoxic T cell (CD8+ naive T cells) and T helper cells (CD4+ naive T cells). It is composed of four distinct chains. blood sample taken from the patients
    Time Frame
    3 months
    Title
    CD16+
    Description
    CD16 is involved in antibody-dependent cell-mediated cytotoxicity and is expressed on large granular lymphocytes (LGLs) of both NK- and T-cell types.blood sample taken from the patients
    Time Frame
    3 months
    Title
    CD56+
    Description
    CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    TSH(thyroid stimulating hormone)
    Description
    TSH stands for thyroid stimulating hormone. A TSH test is a blood test that measures this hormone.
    Time Frame
    3 months
    Title
    T3 (triiodothyronine)
    Description
    This test measures the level of triiodothyronine (T3) in your blood. T3 is one of two major hormones made by your thyroid
    Time Frame
    3 months
    Title
    T4 (Thyroxine)
    Description
    Thyroxine, also known as T4, is a type of thyroid hormone. This test measures the level of T4 in your blood. Too much or too little T4 can indicate thyroid disease.
    Time Frame
    3 months
    Title
    Quality of life questionnaire
    Description
    The World Health Organization (WHO) defined Quality of Life (QoL) as "an individual's perception of their position in life, in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns" . QoL is comprised of multiple aspects, including psychological health, physical well-being, social relationships, and environmental conditions [.
    Time Frame
    3 months
    Title
    Fatigue questionnaire
    Description
    questionnaire is applied to the patients
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of thyroid papillary carcinoma as it is the most common type Treatment with thyroid hormone medication after thyroidectomy Lack of radioactive iodine treatment within the past 6 months Blood hemoglobin level >10 g/dL. Not taking drugs that could affect their immune function (e.g., immunosuppressants such as cyclosporin and steroids . Lack of regular exercise Age 18~45 years Dose should be controlled at the first one year - Exclusion Criteria: 1) Abscess or inflammation suspected by preoperative tests 2) Patients with stage IV cancer and with limited understanding of assessment systems 3) History of head or neck malignancy . 4) Radiation therapy 5) Graves disease 6) Thyroiditis 7) Orthopaedic and rheumatic conditions of the neck . 8) The patient's inability to cooperate -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nabil M Abdel-Aal, PhD
    Phone
    +201200133613
    Email
    nabil.mahmoud@cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohsen M Elsayyad, PhD
    Phone
    +201019661445
    Email
    dr_sayyad1@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohsen Elsayyad, PhD
    Organizational Affiliation
    Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    I will share my data
    IPD Sharing Time Frame
    within 6 months of study completion
    IPD Sharing Access Criteria
    It will be published in medical journals

    Learn more about this trial

    Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy

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