Development of supervised exercise training protocol and comparison with conventional exercises in asymptomatic peripheral arterial disease with type II diabetes mellitus patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Ankle Brachial Index
研究概览
简要总结
People with type 2 diabetes should engage in physical activity regularly and be encouraged to reduce sedentary time and break up sitting time with frequent activity breaks according to ACSM criteria 2022. Asymptomatic PAD remains the most common presentation of the disease. The detailed clinical history, physical changes in the lower leg skin, and examination of peripheral pulses can provide clues to the diagnosis. For decades, exercise has been considered a cornerstone of diabetes management, along with diet and medication.
However, high-quality evidence on the importance of exercise and fitness in diabetes was lacking until recent years. Exercise can directly improve physiological function by reducing blood glucose levels, increasing stamina and emotional well-being and increasing circulation. Peripheral artery disease is independently associated with impaired function, an increased risk of mortality, and decreased quality of life.
RESEARCH GAP:
Lack of standardized protocol for asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.
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Lack of Randomized control trials in evaluating the efficacy of supervised exercises in asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.
Need for outcome-based trials to determine if Supervised Exercise Training protocol offers vascular protection in asymptomatic Peripheral arterial disease with Type II diabetes mellitus patients.
Research needed to evaluate outcomes of early Supervised Exercise Training protocol based on Ankle Brachial Index (ABI) screening in diabetes care.
A lack of Supervised Exercise Training protocol designed for early-stage asymptomatic Peripheral arterial disease for prevention of further complications due to Type II diabetes mellitus.
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
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed by diabetologist with Type II Diabetes Mellitus for more than or equal to 10 years and who will be asymptomatic for symptoms of Peripheral arterial disease 2.Score of 6.5 percent to 11 percent of HbA1C 3.Score of less than 6 on Rapid assessment of Physical Activity 4.Score of 0.5 to less than or equal to 0.9 on 5.Ankle Brachial Index 6.Patients if diagnosed with OA knee, Score on Numeric Pain Rating Scale less than or equal to 3.
排除标准
- •1.Patient following any kind of exercise regime like going to gym, yoga etc.
- •2.Patient having addiction of smoking, tobacco, and alcohol intake 3.Patients already having complications like diabetic foot ulcer, amputation, neuropathy with renal failure and symptoms of claudication 4.Known Cardiopulmonary disorders like Bronchial Asthma, COPD, Myocardial Ishchemia, Angina, Coronary artery disease 5.Patients on Anticoagulants.
结局指标
主要结局
1. Ankle Brachial Index
时间窗: 1. Pre treatment | 2. After 12 weeks
2. HbA1c
时间窗: 1. Pre treatment | 2. After 12 weeks
次要结局
- 1. 6 minute walk distance(2. SF 36)
研究者
Mayuri Shah
Dr. D. Y. Patil College of Physiotherapy