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临床试验/CTRI/2025/03/083086
CTRI/2025/03/083086尚未招募不适用

Effectiveness of Aerobic Exercises versus Eccentric Resisted Exercises Combined with Inspiratory Muscle Training on Pulmonary Function, Body Composition, and Blood Glucose Level in Type 2 Diabetes Mellitus: A Comparative Study

Maharashtra Institute of Physiotherapy Latur1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
111
试验地点
1
主要终点
1)PFT (SP10BT) device: Application (by: Benius Medical System, Faridabad) volume accuracy

研究概览

简要总结

The present study will be conducted with permission from the Institutional ethical committee. Participants will be selected based on inclusion and exclusion criteria.

The entire procedure will be explained and informed written consent is taken from the subjects. The present study involves 111 subjects with age group of 33 to 69 years. After pre-evaluation the participants will be assigned into 3 groups according to simple random sampling.

Group A receiving Aerobic exercises combined with inspiratory muscle training.

Group B receiving eccentric resisted exercises combined with inspiratory muscle training

Group C receiving inspiratory muscle training. all three groups will be given 10 min of warm-up at the start of intervention and 10 minutes of cool-down at the end of intervention. The patients will be assessed prior, at the end of 4th week and at the end of 8th week by assessing their pulmonary function (by Spirometer SP10BT), body composition (by body Fat analyzer) and blood glucose levels (by glucometer).

The exercise protocol will be carried out for 3 days per week, for 8 weeks to all three groups.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
33.00 Year(s) 至 69.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed case of Type 2 diabetes mellitus 2) Patient who can complete 6 min walk test.

排除标准

  • Acute and chronic inflammatory diseases 2) Pregnancy 3) Smoking 4) Chronic alcoholic and drug addiction 5) Patient who has underwent recent cardiothoracic or abdominal surgery.
  • Recent Musculoskeletal injuries.

结局指标

主要结局

1)PFT (SP10BT) device: Application (by: Benius Medical System, Faridabad) volume accuracy

时间窗: At patient enrollment first day 4 th week and 8 th week

+-3% or +-0.05L, flow accuracy +-5% or +-0.2L/S

时间窗: At patient enrollment first day 4 th week and 8 th week

2) Body composition: Body fat analyzer (Actofit Smart Scale Pro Max) (highest accuracy 80-90%)

时间窗: At patient enrollment first day 4 th week and 8 th week

3) Blood Glucose Level: Glucometer (Dr. Morepan Glucometer One BG 02) (0.96)

时间窗: At patient enrollment first day 4 th week and 8 th week

次要结局

  • Patient who are able to complete 6 min walk test(able to complete 6 min walk test)

研究者

发起方
Maharashtra Institute of Physiotherapy Latur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR SANJEEVANI KADAM

MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY LATUR

研究点 (1)

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