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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05265819
• Other study ID #: P.T.REC/012/003356
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Nabil M Abdel-Aal, PhD
• Phone: +201200133613
• Email: nabil.mahmoud[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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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Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

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.

Drug:
• thyroid hormone replacement therapy
thyroid hormone replacement therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nabil Mahmoud Ismail Abdel-Aal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	TSH(thyroid stimulating hormone)	TSH stands for thyroid stimulating hormone. A TSH test is a blood test that measures this hormone.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Fatigue questionnaire	questionnaire is applied to the patients	3 months