Association of pulmonary function with functional capacity and quality of life in patients with type 2diabetes mellitus (T2DM)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- -PEFR
研究概览
简要总结
The study aims to evaluate the association of pulmonary function with functional capacity, physical activity, sleep quality, and quality of life in patients with type 2 diabetes mellitus (T2DM). Participants aged over 40 years with a confirmed diagnosis of T2DM for more than one year will be recruited from the Department of Medicine, Pt. B.D. Sharma PGIMS, Rohtak. Following informed consent, demographic and clinical data, including anthropometric measurements and comorbidities, will be recorded.
Pulmonary function will be assessed using standard spirometric parameters: FVC, FEV1, FEV1/FVC ratio, and PEFR. Physical activity will be evaluated through the International Physical Activity Questionnaire (IPAQ), while functional capacity will be assessed using the Six-Minute Walk Test (6MWT). Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), and overall quality of life will be assessed using the WHOQOL-BREF questionnaire.
This observational study will provide insights into the relationship between lung function and key health-related outcomes in individuals with T2DM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with DM2 for at least 2 month Stable glycemic control (HbA1c less than or equal to 7 percent).
排除标准
- •Patient of DM type I • Communication difficulty • Patients who were diagnosed with neurodegenerative diseases (ataxia, Alzheimer’s, Parkinson’s) • Musculoskeletal problems, such as fractures in general (hip, ankle, wrist, etc.) • Severe cognitive impairment (dementia, memory loss and confusion) • Severe cardiovascular disease (congestive heart failure).
结局指标
主要结局
-PEFR
时间窗: At baseline
6MWT
时间窗: At baseline
IPAQ
时间窗: At baseline
-FEV1
时间窗: At baseline
-FEV1/FVC
时间窗: At baseline
Pulmonary Function Test
时间窗: At baseline
-FVC
时间窗: At baseline
Multidimensional Fatigue Inventory-20
时间窗: At baseline
WHOQOL-Bref scale
时间窗: At baseline
Pittsburgh Sleep Quality Index
时间窗: At baseline
次要结局
未报告次要终点
研究者
Kavita
College of Physiotherapy,Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Medical Road, Rohtak