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

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

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer
• Intervention / Treatment: Drug: thyroid hormone replacement therapy; Device: X-BOX kinetic360; Dietary supplement: mediterranean diet

Detailed Description

Outcome measures

1. Flow cytometry analyzer for NKC (CD3- CD16+ CD56+).
2. Immunoassay analyzer for thyroid profile (TSH,T3,T4)
3. Quality of life questionnaire
4. Fatigue questionnaire
5. PREDIMED questionnaire to asses diet adherence. Outcome measures will be measured at baseline and after 3 months of the treatement intervention

A) assessment

1. Quality of life questionnaire questionnaire
2. .Fatigue questionnaire

3. 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

     1. Exergaming The practice of exergaming was performed using the Xbox 360 Kinect console (Microsoft, Albuquerque, NM)
     2. 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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt, 11829
      • Nabil Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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   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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy	Drug: thyroid hormone replacement therapy; thyroid hormone replacement therapy
Experimental: Group B; Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions	Device: X-BOX kinetic360; 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.; Other Names: thyroid hormone replacement therapy
Experimental: Group C; 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.	Dietary supplement: mediterranean diet; 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.; Other Names: thyroid hormone replacement therapy
Experimental: Group D; Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet	Device: X-BOX kinetic360; 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.; Other Names: thyroid hormone replacement therapy; Dietary supplement: mediterranean diet; 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.; Other Names: thyroid hormone replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
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	3 months
CD56+	CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSH(thyroid stimulating hormone)	TSH stands for thyroid stimulating hormone. A TSH test is a blood test that measures this hormone.	3 months
T3 (triiodothyronine)	This test measures the level of triiodothyronine (T3) in your blood. T3 is one of two major hormones made by your thyroid	3 months
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.	3 months
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 [.	3 months
Fatigue questionnaire	questionnaire is applied to the patients	3 months

Collaborators and Investigators

• Sponsor: Nabil Mahmoud Ismail Abdel-Aal
• Investigators: Study Director: Mohsen Elsayyad, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 5, 2025
• Study Completion (Actual): July 5, 2025

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: P.T.REC/012/003356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No