COPDNCT07079553
Combined Effects of Transcutaneous Electrical Diaphragmatic Stimulation With ACBT'S in Copd
A study testing Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) and Active Cycle of Breathing Techniques (ACBT) in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- COPD
- What is being tested?
- Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) and Active Cycle of Breathing Techniques (ACBT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 28 May 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- COPD (Mild to Moderate)
- Age: 40-60 years of both genders
- Productive cough for more than 2 months
- Oxygen saturation without Oxygen supply > 88%
Who cannot join
- Uncontrolled hypertension
- Cardiac diseases
- Active smokers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Arjumand
Lahore, Punjab Province, 40100
Arjumand Bano, MS-CPPT, 03059551883, arjumand.bano@riphah.edu.pk
Kainat Anwar, MS-CPPT
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Transcutaneous Electrical Diaphragmatic Stimulation (TEDS), Active Cycle of Breathing Techniques (ACBT)
- Keywords
- COPD, TEDS, ACBT, transcutaneous electrical diaphragmatic stimulation, Active Cycle of Breathing Techniques.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Diaphragmatic Stimulation (TEDS)Device
Also called Active Cycle of Breathing Techniques (ACBT)
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.
Active Cycle of Breathing Techniques (ACBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TEDS + ACBT | Experimental | Participants receive transcutaneous electrical diaphragmatic stimulation (TEDS) along with active cycle of breathing techniques (ACBTs) daily for 12 weeks. Receives: 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. Receives: Behavioral: Active Cycle of Breathing Techniques (ACBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
FEV1/FVC Ratio using Spirometry
using Spirometry
Measured: 12 weeks
St. George's Respiratory Questionnaire (SGRQ)
Assesses health-related quality of life specific to respiratory diseases
Measured: baseline and at 12 weeks post intervention
6-Minute Walk Test (6MWT)
Assesses functional exercise capacity.
Measured: Baseline and at 12 weeks post-intervention
Secondary outcomes (1)
Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry
Evaluates oxygen desaturation during physical exertion, reflecting exercise tolerance and pulmonary reserve.
Measured: Baseline and at 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start28 May 2025
- Primary completion28 Oct 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079553
- Sponsor's protocol ID
- REC/RCR&AHS/24/0361C
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Transcutaneous Electrical Diaphragmatic Stimulation With ACBT's in COPD
- ClinicalTrials.gov ID
- NCT07079553
- Acronym / sponsor ID
- REC/RCR&AHS/24/0361C
- Conditions
- COPD
- Keywords
- COPD, TEDS, ACBT, transcutaneous electrical diaphragmatic stimulation, Active Cycle of Breathing Techniques.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEDS + ACBT | Experimental | Device: Transcutaneous Electrical Diaphragmatic Stimulation (TEDS), Behavioral: Active Cycle of Breathing Techniques (ACBT)Participants receive transcutaneous electrical diaphragmatic stimulation (TEDS) along with active cycle of breathing techniques (ACBTs) daily for 12 weeks. |
| ACBT only | Active comparator | Behavioral: Active Cycle of Breathing Techniques (ACBT)Participants receive only active cycle of breathing techniques (ACBTs) daily for 12 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- COPD (Mild to Moderate)
- Age: 40-60 years of both genders
- Productive cough for more than 2 months
- Oxygen saturation without Oxygen supply > 88%
Key exclusion criteria (3 listed)
- Uncontrolled hypertension
- Cardiac diseases
- Active smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Diaphragmatic Stimulation (TEDS)Also: Active Cycle of Breathing Techniques (ACBT)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. | Device | TEDS + ACBT |
| 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. | Behavioural | ACBT only, TEDS + ACBT |
Primary outcome
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.
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.
FEV1/FVC Ratio using Spirometry
Time frame: 12 weeks
using Spirometry
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
6-Minute Walk Test (6MWT)
Time frame: Baseline and at 12 weeks post-intervention
Assesses functional exercise capacity.
1 secondary outcome
Oxygen Saturation after 6-Minute Walk Test (6MWT) via Pulse Oximetry
Time frame: Baseline and at 12 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for COPD
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjumand Bano, MS-CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) and Active Cycle of Breathing Techniques (ACBT) in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in 1 second (FEV1) using Spirometry (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.