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临床试验/NCT07079553
NCT07079553招募中不适用

Combined Effects of Transcutaneous Electrical Diaphragmatic Stimulation With ACBT's in COPD

Riphah International University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Forced Expiratory Volume in 1 second (FEV1) using Spirometry

研究概览

简要总结

The combined effects of transcutaneous electrical diaphragmatic stimulation (TEDS) and active cycle of breathing techniques (ACBTs) in patients with chronic obstructive pulmonary disease (COPD) conducted as a randomized controlled trial at Gulab Devi Hospital, the study involved 50 participants aged 40 to 60 with mild to moderate COPD. Participants were divided into two groups, one receiving both TEDS and ACBT, and the other receiving only ACBT. Over 12 weeks, improvements in lung function, oxygen saturation, exercise capacity, and quality of life were measured using spirometry, pulse oximetry, the 6-minute walk test, and the St. George's Respiratory Questionnaire. Both groups showed significant improvement, but the group receiving ACBT alone showed a slightly higher mean rank in some outcomes. The study concludes that while both interventions are beneficial, ACBT alone may offer more consistent improvements. It recommends including respiratory muscle assessments and combining interventions with education and exercise in future research.

详细描述

This study investigates the effectiveness of combining transcutaneous electrical diaphragmatic stimulation (TEDS) with active cycle of breathing techniques (ACBTs) in the management of chronic obstructive pulmonary disease (COPD). COPD is a progressive respiratory condition characterized by airflow limitation, respiratory muscle weakness, and reduced quality of life. Non-pharmacological interventions like pulmonary rehabilitation, including TEDS and ACBT, have shown individual benefits in improving lung function and exercise tolerance in COPD patients. However, the combined effect of these interventions has not been extensively studied.

The research was designed as a randomized controlled trial conducted at Gulab Devi Hospital, Lahore. A total of 50 patients diagnosed with mild to moderate COPD, aged between 40 and 60 years, were recruited based on defined inclusion and exclusion criteria. Participants were randomly assigned to two groups: Group A received a combination of TEDS and ACBT, while Group B received ACBT alone. The intervention lasted for 12 weeks. TEDS was applied using specific settings-50Hz frequency, 300ms width, 6 seconds of stimulation followed by 5 seconds of rest. ACBT was administered through structured sessions involving breathing control, thoracic expansion, and forced expiratory techniques.

Outcome measures included forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), FEV₁/FVC ratio, oxygen saturation (both at rest and post-exercise), six-minute walk test (6MWT) distance, and the St. George's Respiratory Questionnaire (SGRQ) for quality of life assessment. Data analysis was performed using SPSS version 25, and non-parametric tests were applied due to non-normal data distribution.

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
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •COPD (Mild to Moderate)
  • •Age: 40-60 years of both genders
  • •Productive cough for more than 2 months
  • •Oxygen saturation without Oxygen supply > 88%

排除标准

  • •Uncontrolled hypertension
  • •Cardiac diseases
  • •Active smokers

研究组 & 干预措施

TEDS + ACBT

Experimental

Participants receive transcutaneous electrical diaphragmatic stimulation (TEDS) along with active cycle of breathing techniques (ACBTs) daily for 12 weeks.

干预措施: Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) (Device)

TEDS + ACBT

Experimental

Participants receive transcutaneous electrical diaphragmatic stimulation (TEDS) along with active cycle of breathing techniques (ACBTs) daily for 12 weeks.

干预措施: Active Cycle of Breathing Techniques (ACBT) (Behavioral)

ACBT only

Active Comparator

Participants receive only active cycle of breathing techniques (ACBTs) daily for 12 weeks.

干预措施: Active Cycle of Breathing Techniques (ACBT) (Behavioral)

结局指标

主要结局

Forced Expiratory Volume in 1 second (FEV1) using Spirometry

时间窗: 12 weeks

FEV1 measures the volume of air that can be forcibly exhaled in one second. It is a key indicator of airway obstruction and lung function in COPD patients.

Forced Vital Capacity (FVC) using Spirometry

时间窗: 12 weeks

FVC measures the total amount of air that can be forcibly exhaled after taking the deepest breath possible.

FEV1/FVC Ratio using Spirometry

时间窗: 12 weeks

using Spirometry

St. George's Respiratory Questionnaire (SGRQ)

时间窗: baseline and at 12 weeks post intervention

Assesses health-related quality of life specific to respiratory diseases

6-Minute Walk Test (6MWT)

时间窗: Baseline and at 12 weeks post-intervention

Assesses functional exercise capacity.

次要结局

  • Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry(Baseline and at 12 weeks post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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