跳至主要内容
临床试验/NCT05231031
NCT05231031已完成不适用

Effect of Breathing and Relaxation Exercises on Serum Cortisol Levels in Type 2 Diabetic Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Fating blood glucose

研究概览

简要总结

Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Subject and Methods: sixty, type 2 diabetic patients for more than 5 years were selected from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. Their age ranged from 40 to 50 years. Serum cortisol and blood glucose tests were done before the start of the study and after 6 weeks. The patients were randomly assigned into two equal groups in number (30 patients for each group) performed 3 sessions/week for 6 weeks. Group A received aerobic exercise in the form of walking on a treadmill, breathing exercise, and mindfulness meditation, and group B received continuous aerobic exercise only in the form of walking on a treadmill. ( The exercise program included 45 minutes and consist of warming up phase of slow walking on the treadmill for 5 minutes, training phase 35 minutes, and cooling down for 5 minutes) .

详细描述

Diabetes is a metabolic disorder that requires ongoing medical care through multi-factor risk reduction strategies in addition to blood sugar control. Continuing education and support for diabetes self-management are essential to prevent acute complications and reduce the risk of long-term complications. There is a lot of evidence supporting a number of interventions to improve diabetes outcomes.

Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. This may be due to insufficient insulin secretion, resistance to the peripheral effects of insulin, or both. The synergistic effect of chronic hyperglycemia and other metabolic abnormalities in diabetic patients can cause damage to various organ systems, leading to disabling and life-threatening health complications.

The global prevalence of type 2 diabetes has increased from 8.3% in 2013 to 9.3% in 2019. This increase has been higher in lower- to middle-income countries compared to high-income ones. Diabetes treatment includes behavioral and pharmacological approaches. Globally, it is estimated that only 23% (30% in Latin America) of people with diabetes have reached the set target. However, it is a challenge for treating physicians to choose a treatment that is tailored to each patient.

Egypt is the ninth-largest country in terms of type 2 diabetes mellitus (T2DM) patients, according to the International Diabetes Federation (IDF). T2DM patients have increased threefold in the last 20 years, with a current prevalence of 15.6 percent among people aged 20 to 79.

T2DM is a metabolic disorder that has both microvascular and macrovascular consequences. Controlling blood glucose levels is linked to a lower risk of microvascular consequences (retinopathy, nephropathy, and neuropathy) as well as macrovascular issues (lower incidence of heart attacks, strokes, and better blood flow to the legs).

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 (Care Provider)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Sixty diabetic patients (29 women and 31 men), their age between 45 and 65 years .
  • They had type 2 diabetes mellitus for more than 5years.
  • Their HbA1c value from 6.5% to 7.5%.
  • Stress scores on the Perceived stress scale are >13 in the eligibility check assessment.
  • All patients are under full medical supervision.
  • Their physical activity level is less than 30 minutes of aerobic training in the week.
  • Their body mass index ranged from 25 to 34.
  • (overweight and obesity class I).

排除标准

  • • Any patient is known to have an unstable medical condition and sleeping disorder.
  • Indication of receiving treatments for depression and anxiety.
  • Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
  • Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).
  • Hepatic diseases and dyslipidemia.
  • Patients with renal and vascular diseases.
  • Severe hypertensive patients (higher than 200/120 mmHg).
  • Any acute or chronic inflammatory disorder.

结局指标

主要结局

Fating blood glucose

时间窗: 6 weeks

blood sampling for blood glucose after 9 hours fasting

Serum cortisol level

时间窗: 6 weeks

blood sampling for cortisol at 8 am

次要结局

  • The perceived stress score (PSS)(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hady Atef Labib

Lecturer of physical therapy

Cairo University

研究点 (1)

Loading locations...

相似试验