Effect of Exergaming Exercises and Mediterranean Diet on Thyroid Cancer Patients Following Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CD3-
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: mediterranean diet (Dietary Supplement)
Group D
Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
干预措施: X-BOX kinetic360 (Device)
Group A
Group A: Control group No intervention was provided for 12 weeks except thyroid hormone replacement therapy
干预措施: thyroid hormone replacement therapy (Drug)
Group B
Group B: Exergaming exercise The volunteers carried out 36 exergaming sessions
干预措施: X-BOX kinetic360 (Device)
Group D
Group D: Exergaming exercises and Mediterranean diet Exergaming exercises are used in addition to Mediterranean diet
干预措施: mediterranean diet (Dietary Supplement)
结局指标
主要结局
CD3-
时间窗: 3 months
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+
时间窗: 3 months
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+
时间窗: 3 months
CD56, is a member of the immunoglobulin superfamily engaged in both so-called homophilic and heterophilic interactions.blood sample taken from the patients
次要结局
- TSH(thyroid stimulating hormone)(3 months)
- Fatigue questionnaire(3 months)
- T3 (triiodothyronine)(3 months)
- Quality of life questionnaire(3 months)
- T4 (Thyroxine)(3 months)
研究者
Nabil Mahmoud Ismail Abdel-Aal
Assistant Professor
Cairo University