Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Dynamometer
研究概览
简要总结
To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.
详细描述
This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.
The study will define two groups:
- A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
- An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.
Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.
All measurements given above will be made both to the control group and to the experimental group just prior to the start of the intervention, and immediately after and six months after the end of this period, and the results will be recorded in a data record
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus
- •Not participating in an exercise program
- •That they were able to carry out the different selected questionnaires.
排除标准
- •Contraindications for performing physical tests
- •Illnesses that limit static and dynamic balance and physical activity
- •Central or peripheral vestibular or nervous disorders.
结局指标
主要结局
Dynamometer
时间窗: Up to twelve weeks
Dynamometer will be employed to assess hand grip stregth.
Blood Glucose Concentration
时间窗: Up to twelve weeks
Capillary blood glucose monitoring is the primary tool for monitoring blood glucose levels at any time of day. It involves a small fingertip prick to check blood sugar levels at a specific time of day. This procedure requires a pen containing a fine needle or lancet, test strips, and a glucose meter (glucometer). Reference values vary depending on the time of sample collection: preprandial 80-130 mg/dL and postprandial \<180 mg/dL. In Spain, this measurement is performed among older adults with type 2 diabetes mellitus.
BMI (Body Mass Index)
时间窗: Up to twelve weeks
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
TUG (Timed Up and Go test)
时间窗: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function
Chair sit and reach test
时间窗: Up to twelve weeks
To test low back and hamstring flexibility.
Back scratch test
时间窗: Up to twelve weeks
To measure general shoulder range of motion.
Height
时间窗: Up to twelve weeks
The distance between the lowest and highest points of a person standing upright.
BBS (the Berg Balance Scale)
时间窗: Up to twelve weeks
Used to measure balance
次要结局
未报告次要终点
研究者
Agustín Aibar Almazán
Physiotherapy
University of Jaén