"Comparison Between Two Programs of Inspiratory Muscle Training, Low Resistance vs High Resistance, in Institutionalized Older Women"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Maximal expiratory pressure (MEP)
研究概览
简要总结
Objective: To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in older women to improve respiratory strength, spirometric parameters and dyspnea. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); functional capacity measured with 6 minute walk test; dyspnea using the Borg scale and clinical evaluations. The participants will be evaluated at the beginning and end of the intervention period. Intervention: There are two groups of patients, one works with low loads (20% MIP) and another with high loads (40% MIP). They train 5 days/week 15 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.
详细描述
Participants:
Institutionalized women will be recruited to participate in an 8-week randomized trial.
All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.
Evaluation:
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
- Single (Investigator)
盲法说明
The principal investigator doesn´t know the group of the patients until the study ends
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
"High intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 15 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles.
干预措施: Inspiratory muscle trainer (IMT) (Device)
"Low intensity group"
Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 15 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles.
干预措施: Inspiratory muscle trainer (IMT) (Device)
结局指标
主要结局
Maximal expiratory pressure (MEP)
时间窗: 2 minutes
The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase.
Maximal inspiratory pressure (MIP)
时间窗: 2 minutes
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
次要结局
- Forced expiratory volume in the first second (FEV1)(1 minute)
- Forced vital capacity (FVC)(1 minute)
- Mean expiratory flow (FEF25-75)(1 minute)
- Vital capacity (VC)(1 minute)
- Tidal volume (VT)(1 minute)
- Functional capacity(6 minutes)
- Dyspnea(1 minute)
- Maximum voluntary ventilation (MVV)(1 minute)
- Peak expiratory flow (PEF)(1 minute)
研究者
CARLOS MARTIN SANCHEZ
Principal Investigator
University of Salamanca