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

NCT07079553 | Recruiting

• 1 other identifier: REC/RCR&AHS/24/0361C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

COPD, TEDS, ACBT, transcutaneous electrical diaphragmatic stimulation, Active Cycle of Breathing Techniques.

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry

  Baseline and at 12 weeks post-intervention

Study Arms (2)

TEDS + ACBT

EXPERIMENTAL

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); Behavioral: Active Cycle of Breathing Techniques (ACBT)

ACBT only

ACTIVE COMPARATOR

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

Behavioral: Active Cycle of Breathing Techniques (ACBT)

Interventions

Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) DEVICE

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.

Also known as: Active Cycle of Breathing Techniques (ACBT)

TEDS + ACBT

Active Cycle of Breathing Techniques (ACBT) BEHAVIORAL

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.

ACBT only; TEDS + ACBT

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Uncontrolled hypertension
• Cardiac diseases
• Active smokers

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Arjumand

Lahore, Punjab Province, 40100, Pakistan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arjumand Bano, MS-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: May 28, 2025
• Primary Completion: October 28, 2025
• Study Completion: November 10, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)