COPDNCT06844994
Effects of Manual Diaphragmatic Technique Versus Lateral Coastal Breathing Exercises Among COPD Patients.
A study testing Manual Diaphragmatic Technique and Lateral Coastal Breathing in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic obstructive pulmonary disease is a common, preventable as well treatable disorder, which is also one of the main reasons of high mortality and morbidity characterized by irreversible airflow limitation and has respiratory system involved. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- COPD
- What is being tested?
- Manual Diaphragmatic Technique and Lateral Coastal Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Nov 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-65 years(12). Both gender female and male. Patients willing to be the part of the research. Patients with moderate level of COPD Patients with GOLD II stage(13). Patients who response to bronchodilators Patients with history of smoking(14).
Who cannot join
- Patients having other cardiac diseases. Patients having thoracic or abdominal surgeries. Exacerbation of symptoms before or during study. Inability of Patient to understand instructions due to mental disorder Lack of medical record Coronary artery disease (coronary angiography with stenting or bypass) Malignant tumor Patients with gastrointestinal abnormalities Patients who are in critical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Manual Diaphargmatic Technique Versus Lateral Coastal Breathing Exercise on Dyspnea, Chest Expansion and Functional Capacity Among COPD Patients.
Chronic obstructive pulmonary disease is a common, preventable as well treatable disorder, which is also one of the main reasons of high mortality and morbidity characterized by irreversible airflow limitation and has respiratory system involved. The aim of this study is to evaluate the comparative effects of manual diaphragmatic technique and lateral coastal breathing on COPD patients, that these exercises will have beneficial effects or not on COPD patients. Manual diaphragmatic technique and lateral coastal breathing will increase the functional capacity and relieve the symptoms dyspnea, enhance the chest wall expansion.
Read the detailed description
This study will be a randomized clinical trial to determine the effects of both techniques on COPD patients and disease severity in patients who falls into the inclusion criteria, who are willing to participate, patients with age limit between 45 to 65 years, GOLD stage II, and patients will be excluded who have cardiac disease, abdominal or thoracic surgeries and in critical condition by taking sample of patients through non probability convenient sampling and randomly allocating them to two groups A and B out of which A will receive manual diaphragmatic techniques, B will receive lateral coastal breathing exercise up to the duration of 2 times a day, 3 days per week for up to 3 weeks. Pre and post exercise outcomes will be assessed. The data will be analyzed through SPSS 26
- Conditions
- COPD
- Being tested
- Manual Diaphragmatic Technique, Lateral Coastal Breathing
- Keywords
- chronic obstructive pulmonary disease, Lung disease, Dysnea, Chronic airflow obstruction, Respiratory muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Diaphragmatic TechniqueOther
The intervention will be given 3 days per week for up to 6 weeks starting assessment with modified Borg scale questionnaire will be asked from the patient to evaluate the patient's dyspnea level. The patient at first will be asked to do 5-6 diaphragmatic breathing in upright position and then will be asked to breathe with the breather device after complete inhalation the patient will blow hard in the device. The patient will be asked to inhale and then hold for 2-3 second and breathe out through the device with the 3 sets with each set including 8 repetitions same cycle with relaxed diaphragmatic breathing between each set
Lateral Coastal BreathingOther
The group B will be the lateral coastal breathing that will be given 2 times a day, 3 days per week for up to 6 weeks. The patient will be asked by practitioner to perform 4 to 5 times lateral coastal breathing in suitable sitting or lying position
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Manual Diaphragmatic Technique Receives: Other: Manual Diaphragmatic Technique |
| Group B | Active comparator | Lateral Coastal Breathing Exercises Receives: Other: Lateral Coastal Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Tape
Measuring tape is used for chest wall measurement during inhalation and exhalation to compare differences
Measured: 6th week
6 Mile Walk Test
6 mile walk test is used to perform to check functional capacity of the patient, it helps in assessment of the physical functional performance at baseline and post intervention, 6MWT will be performed inside the corridor on flat surface, the patients will be guided to walk on their own pace.
Measured: 6 weeks
Modified Borg Scale
Modified borg scale questionnaire will be asked from the patient to evaluate the patient's dyspnea level. Peak flow meter It is a handheld device that measures patient ability to push air out of your lungs, it is very useful in screening patients who have respiratory disorders and depicts the reliable respiratory state of the patient
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start26 Nov 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul Ain, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844994
- Sponsor's protocol ID
- REC/RCR & AHS/24/0323 Maliha
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
PubMed 30719351Similowski T, Yan S, Gauthier AP, Macklem PT, Bellemare F. Contractile properties of the human diaphragm during chronic hyperinflation. N Engl J Med. 1991 Sep 26;325(13):917-23. doi: 10.1056/NEJM199109263251304.
PubMed 1881417Siatras TA, Mittas VP, Mameletzi DN, Vamvakoudis EA. The duration of the inhibitory effects with static stretching on quadriceps peak torque production. J Strength Cond Res. 2008 Jan;22(1):40-6. doi: 10.1519/JSC.0b013e31815f970c.
PubMed 18296954Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.
PubMed 27822031Heneghan NR, Adab P, Balanos GM, Jordan RE. Manual therapy for chronic obstructive airways disease: a systematic review of current evidence. Man Ther. 2012 Dec;17(6):507-18. doi: 10.1016/j.math.2012.05.004. Epub 2012 Jun 15.
PubMed 22703901
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Diaphargmatic Technique Versus Lateral Coastal Breathing Exercise on Dyspnea, Chest Expansion and Functional Capacity Among COPD Patients.
- ClinicalTrials.gov ID
- NCT06844994
- Acronym / sponsor ID
- REC/RCR & AHS/24/0323 Maliha
- Conditions
- COPD
- Keywords
- chronic obstructive pulmonary disease, Lung disease, Dysnea, Chronic airflow obstruction, Respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 25 Feb 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.
Chronic obstructive pulmonary disease is a common, preventable as well treatable disorder, which is also one of the main reasons of high mortality and morbidity characterized by irreversible airflow limitation and has respiratory system involved. The aim of this study is to evaluate the comparative effects of manual diaphragmatic technique and lateral coastal breathing on COPD patients, that these exercises will have beneficial effects or not on COPD patients. Manual diaphragmatic technique and lateral coastal breathing will increase the functional capacity and relieve the symptoms dyspnea, enhance the chest wall expansion.
Detailed description
This study will be a randomized clinical trial to determine the effects of both techniques on COPD patients and disease severity in patients who falls into the inclusion criteria, who are willing to participate, patients with age limit between 45 to 65 years, GOLD stage II, and patients will be excluded who have cardiac disease, abdominal or thoracic surgeries and in critical condition by taking sample of patients through non probability convenient sampling and randomly allocating them to two groups A and B out of which A will receive manual diaphragmatic techniques, B will receive lateral coastal breathing exercise up to the duration of 2 times a day, 3 days per week for up to 3 weeks. Pre and post exercise outcomes will be assessed. The data will be analyzed through SPSS 26
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Manual Diaphragmatic TechniqueManual Diaphragmatic Technique |
| Group B | Active comparator | Other: Lateral Coastal BreathingLateral Coastal Breathing Exercises |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 45-65 years(12). Both gender female and male. Patients willing to be the part of the research. Patients with moderate level of COPD Patients with GOLD II stage(13). Patients who response to bronchodilators Patients with history of smoking(14).
Key exclusion criteria (1 listed)
- Patients having other cardiac diseases. Patients having thoracic or abdominal surgeries. Exacerbation of symptoms before or during study. Inability of Patient to understand instructions due to mental disorder Lack of medical record Coronary artery disease (coronary angiography with stenting or bypass) Malignant tumor Patients with gastrointestinal abnormalities Patients who are in critical condition
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 |
|---|---|---|
| Manual Diaphragmatic TechniqueThe intervention will be given 3 days per week for up to 6 weeks starting assessment with modified Borg scale questionnaire will be asked from the patient to evaluate the patient's dyspnea level. The patient at first will be asked to do 5-6 diaphragmatic breathing in upright position and then will be asked to breathe with the breather device after complete inhalation the patient will blow hard in the device. The patient will be asked to inhale and then hold for 2-3 second and breathe out through the device with the 3 sets with each set including 8 repetitions same cycle with relaxed diaphragmatic breathing between each set | Other | Group A |
| Lateral Coastal BreathingThe group B will be the lateral coastal breathing that will be given 2 times a day, 3 days per week for up to 6 weeks. The patient will be asked by practitioner to perform 4 to 5 times lateral coastal breathing in suitable sitting or lying position | Other | Group B |
Primary outcome
Measuring Tape
Time frame: 6th week
Measuring tape is used for chest wall measurement during inhalation and exhalation to compare differences
6 Mile Walk Test
Time frame: 6 weeks
6 mile walk test is used to perform to check functional capacity of the patient, it helps in assessment of the physical functional performance at baseline and post intervention, 6MWT will be performed inside the corridor on flat surface, the patients will be guided to walk on their own pace.
Modified Borg Scale
Time frame: 6 Weeks
Modified borg scale questionnaire will be asked from the patient to evaluate the patient's dyspnea level. Peak flow meter It is a handheld device that measures patient ability to push air out of your lungs, it is very useful in screening patients who have respiratory disorders and depicts the reliable respiratory state of the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 30719351Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
- Background: PubMed 1881417Similowski T, Yan S, Gauthier AP, Macklem PT, Bellemare F. Contractile properties of the human diaphragm during chronic hyperinflation. N Engl J Med. 1991 Sep 26;325(13):917-23. doi: 10.1056/NEJM199109263251304.
- Background: PubMed 18296954Siatras TA, Mittas VP, Mameletzi DN, Vamvakoudis EA. The duration of the inhibitory effects with static stretching on quadriceps peak torque production. J Strength Cond Res. 2008 Jan;22(1):40-6. doi: 10.1519/JSC.0b013e31815f970c.
- Background: PubMed 27822031Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.
- Background: PubMed 22703901Heneghan NR, Adab P, Balanos GM, Jordan RE. Manual therapy for chronic obstructive airways disease: a systematic review of current evidence. Man Ther. 2012 Dec;17(6):507-18. doi: 10.1016/j.math.2012.05.004. Epub 2012 Jun 15.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
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.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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. This study is not recruiting at the moment.
Qurat ul Ain, MS 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 Manual Diaphragmatic Technique and Lateral Coastal Breathing 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Tape (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06844994, which also lists 5 linked publications.
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 25 Feb 2025.