Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Diaphragm mobility
研究概览
简要总结
The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods: Randomized controlled trial (double blinded) with COPD patients, allocated in two group: intervention (IG) who will receive the Diaphragm Release manual technique on 6 non-consecutive sessions and control group (CG), who will receive a sham protocol (light touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise abdominal and chest wall kinematics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •CPOD patients
- •ex-smokers
- •clinically stable patients (no exacerbation in the previous 6 weeks)
- •forced expiratory volume in one second (FEV1) < than 80% predicted
- •FEV1/FVC ≤ 0.7, post bronchodilator
排除标准
- •cardiopulmonary diseases
- •BMI > 30.0 kg/m2
- •History of thoracic surgery
- •Denial to participate
研究组 & 干预措施
Control Group
Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.
干预措施: Manual Diaphragm release technique (sham) (Other)
Intevention Group
All patients will receive the Manual Diaphragm Release Technique, during 6 days of treatment. They will undertake four evaluations throughout treatment: before and immediately after the Day 1 (Baseline 1 and Post 1) and before and after Day 6 (Baseline 6 and Post 6).
In the other Days (2nd to 5th) patients will only receive the intervention and won't be evaluated.
干预措施: Manual Diaphragm Release Technique (Other)
结局指标
主要结局
Diaphragm mobility
时间窗: Diaphragm mobility at first session and after two weeks of treatment.
To evaluate diaphragmatic mobility a high-resolution ultrasound SonoaceR3 (Samsung Medison - South Korea) with a 3.5 MHz convex transducer will be used. Volunteers will remain in a supine position and receive verbal command to perform Inspiratory capacity maneuvers (IC), and the measurement of each curve referring to the diaphragmatic displacement (in mm) will be performed immediately after obtaining the images. The maneuvers will be repeated until obtaining 5 satisfactory images. The average of the three highest values not differing by more than 10% between their values should be accepted.
次要结局
- Compartmental Chest wall volume(Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment)
研究者
Helga Cecília Muniz de Souza
MsC
Universidade Federal de Pernambuco