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临床试验/NCT03693521
NCT03693521已完成不适用

Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial

Göteborg University7 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2019年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
334
试验地点
7
主要终点
Change in physical activity level

研究概览

简要总结

Background: It is recommended that patients with diabetes type 2 keep themselves physically active and it is known that good muscular strength has a positive effect on these patients.

Aim: To determine whether physical activity level increases and whether other risk factors for cardiovascular disease are positively affected by including measurement of handgrip strength as part of the regular care program for patients with diabetes type 2 in primary care.

Method: Patients with diabetes type 2 who go to regular check-ups by participating diabetes-nurses in primary care are randomized to either intervention or control group. In the intervention group, handgrip strength is measured in addition to standard care. the control group receives standard care at inclusion. Handgrip strength is measured in both groups at 1 year follow-up. Physical activity level is measured in both groups at inclusion and 1 year follow-up with a questionnaire. Measurement of other risk factors for cardiovascular morbidity are measured at both inclusion and follow-up in both groups as dictated by standard care routines.

Expected results: Measurement of handgrip strength can give health care personnel greater possibilities to identify those patients with diabetes type 2 who need to increase their activity level and to give them more concrete support. It is possible that the attention given to handgrip strength and physical activity may motivate patients to increase their activity level, become stronger and eventually reduce other risk factors for cardiovascular morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with diabetes type 2 who go to regular check-ups with participating diabetes-nurses at primary health care centres in Region Västra Götaland, Sweden.

排除标准

  • No gender, age or language restrictions.

结局指标

主要结局

Change in physical activity level

时间窗: Change from baseline at 1 year.

Two questions evaluating frequency and intensity of physical activity according to recommendations by the American College of Sports Medicine and the American Heart Association.

次要结局

  • Physical Activity on Prescription(Change from baseline at 1 year.)
  • Change in waist circumference(Change from baseline at 1 year.)
  • Change in HbA1c(Change from baseline at 1 year.)
  • Change in handgrip strength(Change from baseline at 1 year.)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (7)

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