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

July 22, 2025 updated by: Riphah International University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 40100
        • Recruiting
        • Arjumand
        • Contact:
        • Principal Investigator:
          • Kainat Anwar, MS-CPPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 second (FEV1) using Spirometry
Time Frame: 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.
12 weeks
Forced Vital Capacity (FVC) using Spirometry
Time Frame: 12 weeks
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
Time Frame: 12 weeks
using Spirometry
12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time Frame: baseline and at 12 weeks post intervention
Assesses health-related quality of life specific to respiratory diseases
baseline and at 12 weeks post intervention
6-Minute Walk Test (6MWT)
Time Frame: Baseline and at 12 weeks post-intervention
Assesses functional exercise capacity.
Baseline and at 12 weeks post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry
Time Frame: Baseline and at 12 weeks post-intervention
Evaluates oxygen desaturation during physical exertion, reflecting exercise tolerance and pulmonary reserve.
Baseline and at 12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arjumand Bano, MS-CPPT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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