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临床试验/CTRI/2024/03/063667
CTRI/2024/03/063667尚未招募不适用

Effect of resistance exercise on blood glucose level in patient with type 2 diabetes mellitus

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Glycosylated Haemoglobin(HbA1c)

研究概览

简要总结

AIMS AND OBJECTIVES

To study the effect of resistance exercises on blood glucose level (HbA1C) in patients with type 2 Diabetes Mellitus coming to rural health setup

To find out the effect of resistant exercises on blood glucose level

HbA1C

10RM

SELECTION CRITERIA

INCLUSION CRITERIA

1 Patients willing to participate

2 Patients diagnosed with type 2 DM with HbA1C≥ 6.4

3 BMI ≥ 23 kg/m2

4 Patient able to perform 10RM using weight cuff

5 Patients hand grade 3 in MMT

EXCLUSION CRITERIA

1 Elevated BP (resting BP> 200/115)

2 Cardiac disorders such as coronary artery disease, atrial fibrillation.

3 Respiratory disorders .

4 Patient not willing to participate

5 Orthopaedic Abnormalities

EXERCISE PROTOCOL

Exercise Protocol will be of 40 Minutes.

Subjects will be undergoing the exercise session for 40 min for 3days per week for the period of 4 weeks.

The exercise regimen will be consisted of  5mins  warm up session which included  brisk walking , curl ups, neck rotations and gentle stretching.

30 min intervention phase

Upper limb and lower limb patterns was administered in standing, resistance was given through weight cuff (weights cuff were selected ranging from least resistance i.e 0.5 kg to 2kg.) based on 10 RM

According To FITT Principle -

F -  3days /week (alternate days alternate muscle group )

I-   moderate intensity 40% to 60% of 10 RM

T-  30 min

T-  weight cuff

Upper Limb Muscles -

  1. TRAPEZIUS

2.BICEPS

3.TRICEPS

4.PECTORALS  MAJOR

Lower Limb Muscles -

  1. QUADRICEPS

2.HAMSTRINGS

3.CALF

  1. GLUTEI

COOL DOWN PHASE

STRECHINGS FOR THE SAME MUSCLES WILL BE GIVEN

STATISTICAL ANALYSIS

The Data collected will be analyzed by various statistical methods mean, median and test of significance, The data will be analyzed with IBM SPSS 25 for windows statistical software. For all statistical analyses, probability levels of P < 0.05 will be considered statistically significant

STUDY PERIOD  6 Months

AMENDMENT OF PROTOCOL

No change in the study procedure shall be affected without the mutual agreement of investigator, physician and ethical committee

CONFIDENTIALITY

The identity of patient generated in the study will be bounded in strict confidence. The remaining data will be available only to the investigator involved in the study and to the regulatory authorities. Break in the confidentiality is possible only after detail review by the investigator and with the permission of the ethical committee. Information will be disclosed to the concerned person/authority under special circumstances like severe unreported untoward reactions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing to participate 2.Patients diagnosed with type 2 DM with HbA1c ≥ 6.4 3.BMI ≥ 23 kg/m2 4.Patient able to perform 10RM using weight cuff 5.Patients hand grade 3 in MMT.

排除标准

  • Cardiac disorders such as coronary artery disease atrial fibrillation Respiratory disorders Patient not willing to participate Orthopaedic Abnormalities.

结局指标

主要结局

Glycosylated Haemoglobin(HbA1c)

时间窗: Data will be recorded baseline and fourth week

次要结局

  • Repitition maximum(Data will be recorded baseline & fourth week)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Prachi Thorat

Dr Apj Abdul Kalam College Of Physiotherapy

研究点 (1)

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