'Investigating the Effects of Weight Reduction Exercises and Lifestyle Modifications in Reducing the Severity of Flat Foot among Overweight and Obese Individuals A Novel Method of Interventional Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in severity of pes planus (flat foot) measured using a self-designed podoscope, quantified by plantar surface area (PSA) index–based grading.
研究概览
简要总结
This study is a randomized parallel group interventional study designed to evaluate the effect of weight reduction exercises and lifestyle modifications on the severity of flat foot among overweight and obese individuals. Participants aged 18 to 35 years with grade 3 pes planus will be randomly allocated into an intervention group and a control group. The intervention group will receive structured weight reduction exercises and lifestyle modification guidance based on Fit India recommendations for a duration of twelve months while the control group will receive no structured intervention. The primary outcome of the study is the change in severity of pes planus measured using a self designed podoscope. Secondary outcomes include changes in body mass index physical fitness levels and postural parameters. The study hypothesizes that weight reduction exercises and lifestyle modifications will significantly reduce the severity of flat foot in overweight and obese individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •76 subjects aged 18 to 35 had a body mass index BMI of 25 and above and were diagnosed with pes planus grade 3.
排除标准
- •Recent fractures and open wounds in the lower extremities Vitamin D disorder which causes bone deformities like bow legs Stroke end stage kidney disease requiring hemodialysis or widespread malignant disease gallbladder disease Uncontrolled hypertension systolic blood pressure greater than 180 or diastolic blood pressure greater than100 mmHg and other cardiovascular diseases Any major active rheumatologic pulmonary hepatic renal dermatologic disease or inflammatory condition Central nervous system disorders like hemiplegia paraplegia meningitis and other demyelinating diseases.
结局指标
主要结局
Change in severity of pes planus (flat foot) measured using a self-designed podoscope, quantified by plantar surface area (PSA) index–based grading.
时间窗: Baseline (pre-intervention), and at 3 months, 6 months, 9 months, and 12 months post-intervention.
次要结局
- Change in body weight and Body Mass Index (BMI) following exercise and lifestyle modification.(Baseline (pre-intervention), and at 3 months, 6 months, 9 months, and 12 months.)
研究者
Vijayakumar K
Symbiosis Medical College