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

NCT05265819 | Completed

• 1 other identifier: P.T.REC/012/003356
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• TSH(thyroid stimulating hormone)

  3 months

• T3 (triiodothyronine)

  3 months

• T4 (Thyroxine)

  3 months

• Quality of life questionnaire

  3 months

• Fatigue questionnaire

  3 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Drug: thyroid hormone replacement therapy

Group B

EXPERIMENTAL

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

Device: X-BOX kinetic360

Group C

EXPERIMENTAL

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

Group D

EXPERIMENTAL

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

Device: X-BOX kinetic360; Dietary Supplement: mediterranean diet

Interventions

X-BOX kinetic360 DEVICE

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.

Also known as: thyroid hormone replacement therapy

Group B; Group D

mediterranean diet DIETARY_SUPPLEMENT

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.

Also known as: thyroid hormone replacement therapy

Group C; Group D

thyroid hormone replacement therapy DRUG

thyroid hormone replacement therapy

Group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Nabil Mahmoud Ismail Abdel-Aal: lead

Study Sites (1)

Nabil Mahmoud

Cairo, Giza Governorate, 11829, Egypt

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mohsen Elsayyad, PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: March 1, 2022
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: within 6 months of study completion
• Access Criteria: It will be published in medical journals

Locations

EG (1)