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临床试验/CTRI/2025/01/079649
CTRI/2025/01/079649尚未招募3 期

The effect of concurrent exercise training on Hba1c levels, Lipid Profile, Body Composition and Quality of Life in adults with Type 2 Diabetes.

Dr Yuthika Rao1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
QOL

研究概览

简要总结

Total 120 Subjects will be selected on the basis of selection criteria and will be divided in to FOUR (4) groups equally.

Group A  Resistance Training (2 times per week continuously for 12 weeks+ Aerobic Training (2 times per week continuously for 12 weeks)

Group B  Resistance Training (4 times/week)

Group C  Aerobic Training (4 times/week)

Group D  Control Group (usual)

 Â·         Resisted Training Each exercise session will be for 30 -45 minutes in duration. Each session consisted of a warm-up, a resistance training component and a cool-down phase.

·         Aerobic TrainingThis group followed a supervised progressive aerobic training program with exercise intensity developing up to 60–75% of heart rate max (HRmax). Subjects workload will be adjusted to achieve 60% of HRmax and 8-9 RPE for 20-30 minutes and  then progressed to 75% of the HRmax and an RPE of 12-13 for up to 60 minutes.

·         Control group  Active control  group will provided standard care during their normal clinic visits to a consultant physician prescribing medication and general health education. There will be no specific instructions given or skills taught regarding exercise nor additional information regarding dietary modifications. The control group also had pre and post intervention measurements of all parameters and background physical activity measurements. This group of participants will contacted via telephone once every 2 weeks during the 12-week period and will  met  in the middle of the intervention (6-7 weeks). If participants wanted to exercise at home during the study or wanted to stop, they were excluded from the study .

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 and Outcome Assessor Blinded

入排标准

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

入选标准

  • Both Male & Female with age between 35yearto 65year.
  • Diagnosed with T2DM within last 10 years.
  • Blood HbA1c levels between 6.5% to 9.5%.
  • Patients referred only from Physician will be enrolled in the study.

排除标准

  • Patients who refused to participate in the study.
  • History of significant cardiovascular (ischemic heart disease etc.), respiratory (asthma chronic obstructive pulmonary disease etc.), musculoskeletal diseases (osteoarthritis of major joints etc.).
  • People with cognitive impairment, intellectual disability, or mental illness pregnant women.
  • Advanced diabetes induced end-stage organ damage (vascular, retinopathy, nephropathy, neuropathy, retinal hemorrhage or detachment, history of laser therapy).
  • Patients who are on injectable (insulin).
  • Patients on any current supervised exercise training program.

结局指标

主要结局

QOL

时间窗: 12 weeks

Body Composition

时间窗: 12 weeks

HbA1c

时间窗: 12 weeks

Lipid Profile

时间窗: 12 weeks

次要结局

  • Body Composition(Quality of Life)

研究者

发起方
Dr Yuthika Rao
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Yuthika Rao

Mahatma Gandhi University of Medical Sciences and Technology, Jaipur

研究点 (1)

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