跳至主要内容
临床试验/CTRI/2024/07/071176
CTRI/2024/07/071176
尚未招募
2 期

Comparative Analysis of High-Frequency Chest Wall Oscillation (HFCWO) vs. Traditional Chest Physiotherapy (CPT) in the Management of COPD

NO1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月30日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
NO
入组人数
120
试验地点
1
主要终点
Improvement in forced expiratory volume in one second (FEV1)

概览

简要总结

The study will commence with participant recruitment, emphasizing individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who meet the predefined inclusion criteria. After obtaining informed consent, participants will be randomized into two groups: one receiving High-Frequency Chest Wall Oscillation (HFCWO) and the other Traditional Chest Physiotherapy (CPT). A baseline assessment of clinical parameters, respiratory function, and patient-reported outcomes will be conducted. Throughout the intervention period, participants will undergo the assigned therapy according to prescribed protocols.

Regular follow-up visits will assess treatment adherence, monitor potential adverse events, and collect data on relevant physiological and clinical parameters. The study will also incorporate subgroup analyses to explore potential variations in treatment response based on factors such as disease severity or comorbidities. The research team will employ standardized tools to evaluate patient-reported outcomes, ensuring a comprehensive understanding of subjective experiences.

Upon completion of the intervention period, a final assessment will be conducted to compare the effectiveness of HFCWO and CPT in managing COPD. Statistical analyses will be employed to discern any significant differences in clinical outcomes, physiological impact, and patient-reported measures between the two groups. The study’s findings aim to contribute evidence-based insights into the comparative effectiveness of HFCWO and CPT, informing future clinical practices for optimizing respiratory care in individuals with COPD.

Participants in both groups, undergoing the comparative study of High-Frequency Chest Wall Oscillation (HFCWO) and Traditional Chest Physiotherapy (CPT) for the management of Chronic Obstructive Pulmonary Disease (COPD), will receive the following interventions:

HFCWO Group:

Participants in this group will undergo High-Frequency Chest Wall Oscillation using a device connected to an inflatable vest. The vest delivers oscillations or vibrations to the chest wall, facilitating mucus mobilization and airway clearance. Individuals will be trained on proper device usage and encouraged to perform HFCWO sessions as prescribed by healthcare providers.

CPT Group:

Participants assigned to the Traditional Chest Physiotherapy (CPT) group will receive manual chest physiotherapy administered by trained healthcare professionals. This may include percussion, vibration, and postural drainage techniques to assist in mobilizing and clearing respiratory secretions. Participants will attend scheduled sessions where CPT will be applied, and the techniques may be tailored based on individual patient needs and response.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Confirmed COPD Diagnosis: Participants must have a confirmed diagnosis of COPD.
  • 2.Specific Age Range: 18 Years to 45 Years.
  • 3.Stable Disease State: Participants should be in a stable COPD state without recent exacerbations.
  • 4.Informed Consent: Ability to provide informed consent for voluntary participation.
  • 5.Adherence to Treatment Protocols: Willingness to comply with HFCWO and CPT treatment protocols.
  • 6.Ability to Use HFCWO Device or Receive CPT: Physical capability to use HFCWO or receive CPT.
  • 7.Stable Medication Regimen: On a stable COPD medication regimen with documented changes.
  • 9.No Contraindications: Absence of contraindications to HFCWO or CPT.
  • 10.Language Proficiency: Proficient in the language(s) used for study communication and assessments.

排除标准

  • 1.Unstable Medical Conditions: Exclusion of individuals with acute medical conditions other than COPD.
  • 2.Severe Cognitive Impairment: Exclusion of those with severe cognitive impairment affecting decision-making.
  • 3.Recent Exacerbations: Exclusion of participants with recent COPD exacerbations.
  • 4.Severe Respiratory Distress: Exclusion of individuals in severe respiratory distress or requiring urgent medical intervention.
  • 6.Inability to Use HFCWO or Receive CPT: Exclusion of individuals physically unable to use HFCWO or receive CPT.
  • 7.Pregnancy: Exclusion of pregnant individuals for safety reasons.
  • 8.Non-compliance with Study Requirements: Exclusion of those unwilling or unable to comply with study protocols.

结局指标

主要结局

Improvement in forced expiratory volume in one second (FEV1)

时间窗: baseline, 4 weeks & 8 weeks

次要结局

  • Frequency and duration of hospitalizations due to COPD exacerbations.(Change in peak expiratory flow rate (PEFR) or other measures of lung function.)

研究者

发起方
NO
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Pankaj Singh

Galgotias University

研究点 (1)

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