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临床试验/NCT04925128
NCT04925128已完成不适用

Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial

Riphah International University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年1月20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
44
试验地点
2
主要终点
Shoulder Pain

研究概览

简要总结

The study is designed to determine the effects of moderate physical activity on adhesive capsulitis in patients with uncontrolled diabetes mellitus.

详细描述

This study aims to investigate the effect of additional Physical activity programmes in patients with Diabetic Frozen Shoulder (DFS).

Physical activity can help people with diabetes achieve a variety of goals, including increased cardiorespiratory fitness, increased vigour, improved glycemic control, decreased insulin resistance, improved lipid profile, blood pressure (BP) reduction and maintenance of weight loss Frozen shoulder syndrome, also known as adhesive capsulitis, is a clinical entity that refers to a stiff and painful shoulder causing major functional impairment. It affects women more than men, and is mostly associated with diabetes mellitus as a systemic condition. . Frozen shoulder may be either primary idiopathic or secondary to a systemic disease, such as diabetes mellitus.

The adoption and maintenance of physical activity are critical for blood glucose management and overall health in individuals with diabetes. In this Position Statement, we provide a clinically oriented review and evidence based recommendations regarding physical activity and exercise in people with type 2 diabetes.

研究设计

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

盲法说明

single participant according to study

入排标准

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

入选标准

  • 未提供

排除标准

  • The patients with history of shoulder dislocation
  • Lower limb injury,
  • Diabetic foot ulcer,
  • Diabetic neuropathy,
  • Acute or chronic heart disease,
  • Rheumatologic disorder
  • Mobility disorder and post-surgical or trauma related patients will be excluded during the screening.

结局指标

主要结局

Shoulder Pain

时间窗: From baseline to 3rd week and 6th week

Shoulder pain will be assessed with numeric pain rating scale (NPRS), a reliable (Cronbach's α=0.94) and valid tool (CI = 0.96 to 0.98) for assessing pain

Shoulder ROMs

时间窗: From baseline to 3rd week and 6th week

Shoulder abduction, external rotation and internal rotation will be assessed with goiniometer for the degree and quality of this movement. The reliability of goiniometer for shoulder ROMs is ICC=0.94 and validity ICC=0.94.

Shoulder Functionality

时间窗: From baseline to 3rd week and 6th week

Disability of Arm, Shoulder, and Hand (DASH) questionnaire will be used to assess shoulder functionality which is considered a reliable and valid tool for upper limb function. It has been used for shoulder assessment in patients with AC. Validity and Reliability of this scale is (ICC=0.95) and (ICC=0.92) respectively

Average Blood Glucose Level

时间窗: From baseline to 6th week

The average blood glucose level for past two to three months will be measured throgh the HbA1c test, also known as the haemoglobinA1c . The normal range for the hemoglobin A1c level is between 4% and 5.6%. Between 5.7% and 6.4%indicates pre-diabetes. 6.5% or higher indicates diabetes. Validity (r=0.96 and 0.99) and reliability (r=0.95 and 0.97)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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