Impact of Digital High-Intensity Respiratory Muscle Training on Ventilatory Function and Functional Capacity in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Ventilatory function measures (FVC, FEV1, and FEV1/FVC)
研究概览
简要总结
The goal of this Randomize control trail is to determine the effect of Digital High-Intensity Respiratory Muscle Training on ventilatory Function and Functional Capacity in Patients with COPD It will also learn about the safety and tolerability of this digital training program.
The main questions it aims to answer are: Does digital high-intensity respiratory muscle training improve inspiratory and expiratory muscle strength (MIP and MEP)? ,Does it improve functional exercise capacity (6-minute walk distance) and lung function (FEV₁, FVC, FEV₁/FVC)?
详细描述
This single-blinded randomized controlled trial is to determine effect of Digital High-intensity Respiratory Muscle Training delivered through the Sonmol electronic respiratory muscle trainer on ventilatory function and functional capacity in patients with chronic obstructive pulmonary diseases (COPD)
It articulates the clinical rationale by explaining how airflow limitation is caused by COPD and chest hyperinflation, or dysfunction of respiratory muscles, and describes why specific, intense exercise training of muscles of inspiration or expiration may correct or prevent these conditions.
This trial within current evidence supporting respiratory-muscle training and highlights the potential advantages of digital delivery-real-time feedback, adjustable resistance, gamification, and remote monitoring-to boost adherence and training specificity in a rehabilitation context.
The study compares digital high-intensity respiratory muscle training plus conventional pulmonary rehabilitation to conventional pulmonary rehabilitation alone to see if the digital training provides additional benefits.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV)
- •FEV₁ > 80% of predicted.
- •Age 50-65 years.
- •Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold).
- •Clinically stable with no acute exacerbations.
排除标准
- •Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension).
- •Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease).
- •Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures.
- •Cognitive impairment or psychiatric illness that affects cooperation.
- •Participation in another clinical trial or intervention within the last 3 months.
- •Current use of any other respiratory muscle training device or app.
研究组 & 干预措施
Group A (study group)
30 patient who will receive high-intensity respiratory training with the digital Sonmol Respiratory Muscle Trainer for 15 to 20 Minutes, in addition to a conventional pulmonary rehabilitation program for 25 to 30 Minutes, with a total duration of 50 to 60 minutes for each session.
, 3 sessions/week, for 8 weeks.
干预措施: Digital Sonmol Respiratory Muscle Trainer (Device)
Group A (study group)
30 patient who will receive high-intensity respiratory training with the digital Sonmol Respiratory Muscle Trainer for 15 to 20 Minutes, in addition to a conventional pulmonary rehabilitation program for 25 to 30 Minutes, with a total duration of 50 to 60 minutes for each session.
, 3 sessions/week, for 8 weeks.
干预措施: conventional respiratory rehabilitation (Other)
Group B (control group)
30 patient who will receive the conventional pulmonary rehabilitation program for 25 to 30 minutes for each session, 3 sessions / week, for 8 weeks.
干预措施: conventional respiratory rehabilitation (Other)
结局指标
主要结局
Ventilatory function measures (FVC, FEV1, and FEV1/FVC)
时间窗: twice, first before beginning treatment from day 1 of treatment second after complete treatment after 2 months ,Assessment will be for 5 minutes for ventilatory function
will be assessed by using Spirometry (smartSOFTmee version 2.14.21) FVC (Forced Vital Capacity): The maximum volume of air that a person can forcibly exhale after taking a full, deep inhalation. FEV₁ (Forced Expiratory Volume in 1 second): The volume of air exhaled during the first second of the forced expiratory maneuver. FEV₁/FVC ratio: The percentage of the total forced vital capacity exhaled in the first second, used to assess the presence of airflow obstruction. After preparing the device and the patient and delivering instructions, each patient will assume the sitting position with a nose clip on the nose, they will asked to take a deep breath quickly, with a hold of more than one second at TLC, next, firmly seal the mouthpiece with the lips, then execute the FVC technique. Lastly, forcefully exhale for as long as he/she can and as quickly as feasible while loudly asking for more, more, more. This process should last for at least six seconds
Functional capacity by 6MWT
时间窗: twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 6 minute
The 6MWT will be used to measure functional exercise capacity. The investigator measures blood pressure, heart rate, and oxygen saturation. The Patient wears clothing and footwear that are safe for testing. The walking surface will be hard and flat. Often, two cones are set up about 100 feet (30 meters) and the patient will walk back and forth between them for six minutes. At the end of the test, the investigator calculates the distance the patient walked in 6 minutes,
次要结局
- Respiratory muscle strength (MIP and MEP).(twice, first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 3 minute)
- Patient-reported outcomes by CAT score(twice ,first before beginning treatment from day 1 of treatment ,second after complete treatment after 2 month Assessment will be for 4 minute)
研究者
Hagar Waly
principal investigator MSc candidate
Cairo University