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临床试验/CTRI/2024/02/063021
CTRI/2024/02/063021已完成不适用

Relationship between Sarcopenia 6-Minute walk test and Quality of Life in Diabetic patients aged over 50 years- Pilot study.

Rajiv Gandhi University of Health Sciences1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
To investigate the correlation between Glycemic control and Sarcopenia among Diabetic patients aged over 50 years

研究概览

简要总结

Aim: To find the relationship between Sarcopenia, 6-Minute walk test (6-MWT) and Quality of life in Diabetic patients aged over 50 years.

The incidence and Prevalence of metabolic and musculoskeletal diseases are increasing. In which Type 2-DM accounts for around 90% of all cases. It is a complex heterogenous metabolic disorder and causes dysfunction in multiple organs and tissues. Type 2 Diabetes is a highly prevalent health problem in the elderly, affecting  >25% of people aged  > 65 years. Older adults with Diabetes are known to have higher rate of functional decline and disability. Now, Sarcopenia is recognized as another co-morbidity in older adults with Diabetes. Diabetes as been reported to accelerate the reduction of muscle mass and strength by several mechanisms like protein synthesis is stimulated by insulin and impairment in the insulin-associated signaling pathway might lead to reduced muscle anabolism and increased protein catabolism, which contribute to sarcopenia.

Sarcopenia is defined as a syndrome of progressive and generalized loss of skeletal mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death  by the European Working Group on Sarcopenia in older people (EWGSOP). The three core criteria are low muscle mass, low muscle strength and poor physical performance.

The gold standard methods for assessing the muscle mass are CT, MRI and DEXA which can assess the skeletal muscle mass accurately. However, these assessments cannot be performed frequently because of the radiation exposure and complexity. Ultrasonography is a rapid, affordable and a non-invasive technique that is widely available. It is a promising technique for estimating the skeletal muscle mass, quality and architecture and thus possibly useful for diagnosing or screening Sarcopenia. 6-MWT is a measure of physical fitness, a submaximal test to assess the aerobic capacity and endurance. The strength of the muscle is assessed by 1-Repetition maximum (RM) which is a gold standard method for assessing the strength capacity in the Non-laboratory settings.

In this study we will be looking at the Quadriceps Femoris muscle for which the 1-RM will be assessed and the Ultrasound of the same will be taken. Girth measurement of Quadriceps femoris and Calf muscle, Hand Grip strength of the forearm muscles will be assessed. The HbA1c value will be collected from the participants. 6-MWT will be performed and participants will be asked to fill in SARC-F and SarQoL Questionnaire.

Proper evidence based studies are not done to find the relationship between sarcopenia, 6-MWT and Quality of life in Diabetic patients, thus by this study we can develop an effective, easily accessible and safe assessment pattern to determine the exercise capacity and use those results to prescribe  exercise.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Type 2- Diabetic patients.

排除标准

  • Chronic cardiac condition.
  • Neurological Impairments.
  • Musculoskeletal Deformities.
  • Non cooperative Participants.

结局指标

主要结局

To investigate the correlation between Glycemic control and Sarcopenia among Diabetic patients aged over 50 years

时间窗: At the end of the 1st session.

次要结局

  • To find the relationship between sarcopenia and 6-minute walk test(6-MWT) in Diabetic patients(At the end of the 1st session.)
  • To find Quality of life in Diabetic patients with Sarcopenia.(At the end of the 1st session.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Swetha Jennifer S

St Johns Medical College

研究点 (1)

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