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NCT Number: NCT07079553

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.

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Key information

Conditions

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

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arjumand

Lahore, Punjab Province, 40100, Pakistan

Location status: Recruiting

Location contact

Arjumand Bano, MS-CPPT

CONTACT

[email protected]

03059551883

Kainat Anwar, MS-CPPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Active Cycle of Breathing Techniques (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.

Primary outcomes

  1. 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.

  2. 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.

  3. FEV1/FVC Ratio using Spirometry

    Time frame: 12 weeks

    using Spirometry

  4. 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

  5. 6-Minute Walk Test (6MWT)

    Time frame: Baseline and at 12 weeks post-intervention

    Assesses functional exercise capacity.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad, phd

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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