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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Device: Transcutaneous Electrical Diaphragmatic Stimulation (TEDS); Behavioral: Active Cycle of Breathing Techniques (ACBT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 40100
      • Recruiting
      • Arjumand
      • Contact: Arjumand Bano, MS-CPPT; Phone Number: 03059551883; Email: arjumand.bano@riphah.edu.pk
      • Principal Investigator: Kainat Anwar, MS-CPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEDS + ACBT; Participants receive transcutaneous electrical diaphragmatic stimulation (TEDS) along with active cycle of breathing techniques (ACBTs) daily for 12 weeks.	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.; Other Names: Active Cycle of Breathing Techniques (ACBT); 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.
Active Comparator: ACBT only; Participants receive only active cycle of breathing techniques (ACBTs) daily for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second (FEV1) using Spirometry	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.	12 weeks
Forced Vital Capacity (FVC) using Spirometry	FVC measures the total amount of air that can be forcibly exhaled after taking the deepest breath possible.	12 weeks
FEV1/FVC Ratio using Spirometry	using Spirometry	12 weeks
St. George's Respiratory Questionnaire (SGRQ)	Assesses health-related quality of life specific to respiratory diseases	baseline and at 12 weeks post intervention
6-Minute Walk Test (6MWT)	Assesses functional exercise capacity.	Baseline and at 12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry	Evaluates oxygen desaturation during physical exertion, reflecting exercise tolerance and pulmonary reserve.	Baseline and at 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Arjumand Bano, MS-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): October 28, 2025
• Study Completion (Estimated): November 10, 2025

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: COPD, TEDS, ACBT, transcutaneous electrical diaphragmatic stimulation, Active Cycle of Breathing Techniques.
• Other Study ID Numbers: REC/RCR&AHS/24/0361C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No