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临床试验/NCT03200795
NCT03200795Unknown不适用

Effect of Rebound Exercises and Circuit Training on Musculoskeletal Pain, Selected Biochemical and Psychosocial Parameters Among Individuals With Type 2 Diabetics

University of KwaZulu2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Cholesterol level Change is being assessed

研究概览

简要总结

Background. Diabetes is a global epidemic disease. The prevalence of diabetes for all age groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030. The global prevalence of diabetics is currently estimated to be 285 million and projection rates are expected to rise to over 438 million by the year 2030, with Asians suffering the bulk of the total diabetes epidemic.

The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on the increase amongst the South African population. Due to the numerous factors such as lack of education, inaccessibility of healthcare facilities and/or poor socio-economic background, diabetes mellitus often goes undetected in rural areas, resulting in an increase in musculoskeletal complication and other diabetes mellitus complications. Inability to control blood sugar may induce serious complications such as renal disease, peripheral neuropathy, retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the development of additional manifestations such as musculoskeletal complications, reduces respiratory capacity, depression and poor quality of life.

Studies have shown that both exercises and pharmacotherapy can decreases depression and improved glycemic control and overall quality of life of persons with diabetes. Thus, in addition improve the quality of life and substantial financial savings and improved medical care of these individuals.

Hypothesis

  1. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of rebound exercises.
  2. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of circuit resistance training.
  3. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients at the baseline and at the end of 8 weeks of routine care.
  4. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the baseline.
  5. There will be no statistical significant difference in glycemic control, cholesterol level, respiratory parameters, pain scores, depression and quality of life among type 2 diabetes patients between the rebound exercises group, circuit training and routine care at the end of 8 week of the programme.

Summary of the proposed research methodology. The participants will be randomised into three groups. The first group will be engaged in rebound exercise, the second group will be engaged in circuit training while the third group will continue with their normal care of medication. But before the commencement of the study, pilot study will be conducted on normal subjects. Measurement will be carried out at the baseline, four weeks and at the end of the programme, 'The following parameters will be measured. Pain level, blood glycemic level of each participant, cholesterol level, depression and quality of life.

详细描述

Background Diabetes is a global epidemic disease. The prevalence of diabetes for all age groups worldwide was estimated to be 2.8% in 2000 and is predicted to affect 4.4% by 2030. The global prevalence of diabetics is currently estimated to be 285 million and projection rates are expected to rise to over 438 million by the year 2030, with Asians suffering the bulk of the total diabetes epidemic.

The incidence of chronic diseases of lifestyle such as Type 2 Diabetes Mellitus (DM) is on the increase amongst the South African population. Due to the numerous factors such as lack of education, inaccessibility of healthcare facilities and/or poor socio-economic background, diabetes mellitus often goes undetected in rural areas, resulting in an increase in musculoskeletal complication and other diabetes mellitus complications resulting in increased in diabetes and its complications. Inability to control blood sugar may induce serious complications such as renal disease, peripheral neuropathy, retinopathy, and vascular events. Due to its multi-systemic nature, diabetes will lead to the development of additional manifestations such as musculoskeletal complications, reduces respiratory capacity, depression and poor quality of life.

Musculoskeletal (MSK) complications of diabetes mellitus (DM) are the most common endocrine arthropathies. These have been generally under-recognized and poorly treated compared with other complications, such as neuropathy, retinopathy, and nephropathy. These manifestations, which are some of the causes of chronic disability. This involve not only the joints, but also the bones and the soft tissues. In 2004, the National Health Interview Survey determined that 58% of diabetic patients would have functional disability. The percentage of diabetic patients with functional disability will increase as the number of diabetic patients increases, and hence constitute a major public health problem. Recent data show that the prevalence of MSK manifestations in the hands and shoulders in patients with type 1 or type 2 diabetes is 30%. These manifestations are closely linked to age, prolonged disease duration, and vascular complications in the form of retinopathy.

Depression have been associated with diabetes these depressive symptoms are more likely to persist among persons with multiple diabetic-related complications like musculoskeletal disorders. Studies have shown that both exercises and pharmacotherapy can decreases depression and improved glycemic control and overall quality of life of persons with diabetes. Thus, in addition improve the quality of life and substantial financial savings and improved medical care of these individuals.

Musculoskeletal disorders and disability are very common in diabetes and are associated with worse glycemic control and more complications. Assessment of musculoskeletal disorders among diabetes should include an estimate of cholesterol, glycemic control, pain, respiratory parameters and quality of life. People with diabetes are twice at risk of suffering from premorbid depression as the general population. The coexistence of depression in people with diabetes catalyses serious disease comorbidities, MSK complications, decreased respiratory capacity, poor glycemic control which may lead to hyperlipidemia and poor quality of life and escalated healthcare expenditures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

盲法说明

To eliminate bias, the assessment of outcome will be performed by (experienced) blinded assessors, who will be blinded to the type of intervention as well as the intervention groups of the participants. Participants will also be instructed not to disclose their individual intervention groups to the assessors

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with diagnosis of type 2 diabetes for at least 4 years on oral hypoglycemic control
  • Age between 20 to 55 years
  • Musculoskeletal affectation and depression,
  • Consent to participate in the study.

排除标准

  • Subjects who are involved in sporting activities
  • Those whose musculoskeletal problems are severe and may prevent them from performing some of the exercises.
  • Individuals with hypertension
  • Coronary artery disease
  • Myocardial infarction
  • Cardiac or abdominal surgery
  • Previous 6 months, history of fractures of the spine, hip, knee and ankle joints
  • Lower limb weakness and deformities with loss of protective sensation in the feet.
  • Pregnancy or lactation
  • Use of insulin
  • Presence of retinopathy,
  • Nephropathy
  • Subjects who do not consent to participate.

研究组 & 干预措施

Rebound exercise group

Experimental

Participants randomized to this group will be instructed on the proper techniques of the desired movements (hopping) on the rebounder.

干预措施: Rebound exercise (Other)

Circuit training group

Experimental

The circuit training for the participants in this group will be designed for each participant. Training will take place 3 times a week for 8 weeks. The participants will undergo 10 minutes warm up before and 10 minutes cool down after the training. Resistance exercises will be performed on weight machines. Throughout the resistance training program, participants will be alternating between the bench press, seated row, lateral pull down, biceps forward, front thigh, back thigh, leg press and rowing.

干预措施: Circuit training exercise (Other)

结局指标

主要结局

Cholesterol level Change is being assessed

时间窗: Baseline and at the end of eight week of the study

The cholesterol level will be measure using accutrend pus

Pain Change is being assessed

时间窗: Baseline and at the end of eight week of the study

Musculoskeletal pain will be assess, using visual analog scale (VAS)

Blood glucose level Change is being assessed

时间窗: Baseline and at the end of eight week of the study

The sugar level will be measure using accutrend plus

次要结局

  • Depression Change is being assessed(Baseline and at the end of the eight week of the study)
  • Quality of life Change is being assessed(Baseline and at the end of the eight week of the study)

研究者

发起方
University of KwaZulu
申办方类型
Other
责任方
Sponsor

研究点 (2)

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