Combined Effects of Transcutaneous Electrical Diaphragmatic Stimulation With ACBT'S in Copd

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device Transcutaneous Electrical Diaphragmatic Stimulation (TEDS)
  TEDS was applied using surface electrodes placed over the diaphragm region. The stimulation protocol was set at 50 Hz frequency, 300 μs pulse width, with 6 seconds of stimulation followed by 5 seconds of rest, daily for 12 weeks. It was combined with ACBT sessions.
• Behavioral Active Cycle of Breathing Techniques (ACBT)
  ACBT sessions included breathing control, thoracic expansion exercises, and forced expiration techniques (huffing). Sessions were performed daily for 12 weeks to aid in secretion clearance and improve lung function.

Primary outcome measures

• Forced Expiratory Volume in 1 second (FEV1) using Spirometry [Time frame: 12 weeks]
• Forced Vital Capacity (FVC) using Spirometry [Time frame: 12 weeks]
• FEV1/FVC Ratio using Spirometry [Time frame: 12 weeks]
• St. George's Respiratory Questionnaire (SGRQ) [Time frame: baseline and at 12 weeks post intervention]
• 6-Minute Walk Test (6MWT) [Time frame: Baseline and at 12 weeks post-intervention]

Secondary outcome measures (1)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Uncontrolled hypertension
• Cardiac diseases
• Active smokers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Arjumand — Lahore

Identifiers

NCT: NCT07079553 · REC/RCR&AHS/24/0361C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗