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临床试验/CTRI/2024/06/069084
CTRI/2024/06/069084
招募中
2/3 期

Effect of Telerehabilitation versus Conventional Rehabilitation on Physical, Physiological and Psychological parameters in Type 2 Diabetes Mellitus patients: A Systematic Design Comparative Study

Jamia Hamdard University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月1日最近更新:

概览

阶段
2/3 期
状态
招募中
入组人数
80
试验地点
1
主要终点
A Physiological parameters

概览

简要总结

It aims to evaluate the impact of these rehabilitation methods on patients, physical, physiological, and psychological parameters. The study will employ a randomized controlled trial design, with outcomes measured in terms of body metrics, blood markers, and psychological assessments. The research aims to assess the effectiveness of telerehabilitation, which could revolutionize the delivery of healthcare services, especially for diabetes patients facing barriers to person care.

Exercise Intervention

Both the groups perform same exercise program for 12 weeks (3 times/week). The experimental group perform the exercise program through video conferencing. The control group perform exercise program in rehabilitation OPD settings.

Tai chi exercise

The tai chi attended two 1 hour classes per week for 12 weeks. The tai chi program for this study was based on ‘yang and sun style 20-form’, which has been designed for people with diabetes.

Callisthenic exercise

Callisthenic exercise that consists of 16 different, rhythmical exercises of strengthening and stretching of the lower and upper extremity muscles (Appendix A). Before the callisthenic exercises, warm-up exercises involving lower and upper extremity joint movements were repeated 10 times each. During the first and second weeks, the third and fourth weeks and the fifth and sixth weeks, the exercises were performed 10–15, 15–20 and 25–30 times per session, respectively. The duration of the exercise sessions was between 20 and 45min.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • a) Age criteria 30-65 years b) At least 6 month of diabetes mellitus c) Type 2 Diabetes Mellitus.

排除标准

  • a) Clinically unstable b) Neuromuscular diseases c) Pregnancy d) Unstable cardiovascular disease e) Inability or unwilling to comply with the required exercise f) Free from any cardiovascular medication g) Any other disease.

结局指标

主要结局

A Physiological parameters

时间窗: 0th (baseline) and 12th week after the intervention

1 Hba1c

时间窗: 0th (baseline) and 12th week after the intervention

2 Lipid profile

时间窗: 0th (baseline) and 12th week after the intervention

3 HRV, Blood glucose

时间窗: 0th (baseline) and 12th week after the intervention

4 Blood pressure

时间窗: 0th (baseline) and 12th week after the intervention

5 Vo2 max

时间窗: 0th (baseline) and 12th week after the intervention

次要结局

  • A Physical parameters(1 balance (using Y balance scale))

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Huma

Jamia Hamdard

研究点 (1)

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