Clinical trial NCT05265819: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

-

Primary outcomes:
measure: CD3-
timeFrame: 3 months
measure: CD16+
timeFrame: 3 months
measure: CD56+
timeFrame: 3 months
Secondary outcomes:
measure: TSH(thyroid stimulating hormone)
timeFrame: 3 months
measure: T3 (triiodothyronine)
timeFrame: 3 months
measure: T4 (Thyroxine)
timeFrame: 3 months
measure: Quality of life questionnaire
timeFrame: 3 months
measure: Fatigue questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Mohsen Elsayyad, PhD
role: STUDY_DIRECTOR
References: