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临床试验/CTRI/2025/08/092670
CTRI/2025/08/092670招募中2 期

Develop,Implement, and Evaluate of a Workplace-Based Resistance Training Intervention for Glycemic Control Among Office Workers with Type 2 Diabetes Mellitus.

Eswaran.T.P.M1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Glycemic control measured by:

研究概览

简要总结

This research project aims to develop, implement, and evaluate a workplace-based resistance training intervention to improve glycemic control among office workers with type 2 diabetes mellitus. The study is structured in three phases. Phase 1 involves developing a context-specific resistance training protocol through expert consensus using a Formative Research method. Phase 2 will conduct a pilot randomized controlled trial to test the effectiveness of the intervention on glycemic outcomes and related health parameters among office workers. Phase 3 will assess the feasibility and acceptability of the intervention through mixed-methods research. The intervention includes resistance exercises using resistance bands performed during work hours. This study addresses the significant burden of diabetes in sedentary office workers and aims to fill current gaps in workplace wellness programs by focusing on resistance training.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • The study includes adults aged between 30 to 55 years who are full-time employees engaging in sedentary office work for at least five hours daily and have a diagnosis of Type 2 Diabetes Mellitus with controlled glycemic levels, specifically HbA1c between 6.5% to 7.5% and fasting blood glucose between 124 to 200 mg/dL.
  • Both men and women working regular daytime hours in the office are eligible.
  • The intervention group consists of staff from the Manipal Academy of Higher Education (MAHE), whereas the control group includes personnel from other similar workplace settings.

排除标准

  • encompass individuals with medical or orthopedic conditions restricting the ability to perform resistance exercises, pregnant or lactating women, those with uncontrolled diabetes indicated by HbA1c above 7.5%, those on unstable job status intending to leave within four months, current participation in other structured resistance training programs, allergies to materials used in exercises (e.g., latex), and those with neurological or nephrological complications such as foot ulcers limiting physical activity.

结局指标

主要结局

Glycemic control measured by:

时间窗: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)

1. HbA1c percentage and mmol/mol

时间窗: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)

2. Fasting blood glucose (mg/dL)

时间窗: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)

次要结局

  • 1. Blood pressure (millimeters of mercury)(2. Heart rate variability (milliseconds))

研究者

发起方
Eswaran.T.P.M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

EswaranTPM

Manipal College of Health Professions, Manipal Academy of Higher Education

研究点 (1)

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