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临床试验/NCT04026139
NCT04026139已完成不适用

Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis

Shu-Mei Chen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
HbA1c level

研究概览

简要总结

Whether elastic band resistance exercise (EBRE) as a home-based rehabilitation routine can control the glycated heamoglobin (HbA1c) level and improve the muscle strength, dynamic balance, and physical function in older patients with comorbid T2DM and knee OA?

详细描述

Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM together with knee OA. Intervention: Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week. The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.

研究设计

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

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for this study were as follows: age between 60 and 70 years; comorbid T2DM and knee OA diagnosed by a physician; and Kellgren and Lawrence (K&L) grade <3 based on the findings of plain radiographs.

排除标准

  • Exclusion criteria were as follows: inability to perform any self-activity; DM with complications, such as lower extremity neuropathy, retinopathy, stroke, foot wounds, or amputations; K&L grade >3, hip or knee arthroplasty; history of myocardial infarction; uncontrolled liver and kidney disease; and uncontrolled hypertension.

研究组 & 干预措施

experimental group

Experimental

Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week.

干预措施: Elastic Band Resistance Exercise (Other)

control group

Active Comparator

The control group underwent active joint range-of-motion exercises and isometric contraction exercises.

干预措施: active joint range-of-motion exercises and isometric contraction exercises (Other)

结局指标

主要结局

HbA1c level

时间窗: up to 12 weeks of intervention

follow blood glucose cotrol

WOMAC physical function subscale scores

时间窗: up to 12 weeks of intervention

follow osteoarthritis physical function

30-s chair stand test [CST]

时间窗: up to 12 weeks of intervention

follow low leg muscle strength

3-m timed up and go test [TUG]

时间窗: up to 12 weeks of intervention

follow dynamic balance

次要结局

未报告次要终点

研究者

发起方
Shu-Mei Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shu-Mei Chen

ChangGungMH

Chang Gung Memorial Hospital

研究点 (2)

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