Chronic Obstructive Pulmonary DiseaseNCT07065162
Effects of Subtle Touch Technique and Active Cycle of Breathing Technique
A study testing Subtle Touch Technique and Active Cycle of Breathing Technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. Subtle Touch, also known as Calatonia, involves a profound relaxation approach that regulates muscle tension and fosters physical and psychological equilibrium in patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Subtle Touch Technique and Active Cycle of Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2025to 30 Jan 2026
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 65
- Patients with mild to moderate COPD (according to Gold Criteria)
- Both male and female (18).
Who cannot join
- Musculoskeletal disorders
- Any recent chest injuries
- Lung infections
- Pulmonary hypertension (18)
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
Gulab Devi Hospital
Lahore, Punjab Province, 54000
Iram Nawaz, mphill, 03324645227, iram_029@yahoo.com
Alma Rania, MSCPPT
About this study
Official title: Combined Effects of Subtle Touch Technique and Active Cycle of Breathing Technique in COPD
COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. Subtle Touch, also known as Calatonia, involves a profound relaxation approach that regulates muscle tension and fosters physical and psychological equilibrium in patients. The study will employ a randomized controlled trial, with total 40 participants divided into two groups. Group A will receive ACBTs three times daily for fifteen minutes for eight weeks. Group B will receive ACBT along with subtle touch technique for three times daily for fifteen minutes for eight weeks. The nonprobability convenient sampling technique, followed by random allocation using sealed opaque enveloped method.The inclusion criteria will be focusing on patients of 45 to 60 years of age, patients with mild to moderate COPD (according to Gold Criteria) and both male and female. While exclusion criterion includes musculoskeletal disorders, any recent chest injuries, lung infections and pulmonary hypertension. The methodology will involve 8-week intervention period, conducted at pulmonology department of Jinnah hospital, with participants in each group receiving instruction and support in their respective breathing techniques. All patients will be assessed using Digital Spirometer (to evaluate pulmonary functions), Breathlessness Cough and Sputum Scale BCSS (to evaluate sputum diary of patients), Modified Borg Dyspnea Scale and St. George's Respiratory Questionnaire (SGRQ). The data analysis will be done by using SPSS version 25. After assessing Combined Effects of ACBT and Subtle Touch Technique in COPD normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Read the detailed description
COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. In 2018, approximately 5.1% of adults (equivalent to around 12.8 million individuals) received a COPD diagnosis. Subtle Touch, also known as Calatonia, involves a profound relaxation approach that regulates muscle tension and fosters physical and psychological equilibrium in patients. It entails gentle stimulation of nerve receptor-rich areas of the body, promoting muscle relaxation and potentially improving respiratory muscle function. The study will employ a randomized controlled trial, with total 40 participants divided into two groups. Group A will receive ACBTs three times daily for fifteen minutes for eight weeks.
Group B will receive ACBT along with subtle touch technique for three times daily for fifteen minutes for eight weeks. The nonprobability convenient sampling technique, followed by random allocation using sealed opaque enveloped method, ensures a diverse yet unbiased sample. The inclusion criteria will be focusing on patients of 45 to 60 years of age, patients with mild to moderate COPD (according to Gold Criteria) and both male and female. While exclusion criterion includes musculoskeletal disorders, any recent chest injuries, lung infections and pulmonary hypertension. The methodology will involve 8-week intervention period, conducted at pulmonology department of Jinnah hospital, with participants in each group receiving instruction and support in their respective breathing techniques. All patients will be assessed using Digital Spirometer (to evaluate pulmonary functions), Breathlessness Cough and Sputum Scale BCSS (to evaluate sputum diary of patients), Modified Borg Dyspnea Scale and St. George's Respiratory Questionnaire (SGRQ). The data analysis will be done by using SPSS version 25. After assessing
1 Combined Effects of ACBT and Subtle Touch Technique in COPD normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Subtle Touch Technique, Active Cycle of Breathing Technique
- 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.
Subtle Touch TechniqueOther
Also called Active Cycle of Breathing Technique
3 cycles of ACBT along with subtle touch technique for 15 minutes 3 times daily for 8 weeks, in addition to the standard COPD care and medication.
Active Cycle of Breathing TechniqueOther
3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication.
| Study group | Role | What they receive |
|---|---|---|
| Subtle Touch Technique with Active Cycle of Breathing Technique | Experimental | Group A will receive 3 cycles of ACBT along with subtle touch technique for 15 minutes 3 times daily for 8 weeks, in addition to the standard COPD care and medication. Receives: Other: Subtle Touch Technique |
| Active Cycle of Breathing Technique | Active comparator | Group B will receive 3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication. Receives: Other: Active Cycle of Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's Respiratory Questionnaire (SGRQ)
Patients were assessed through the help of Saint George respiratory Questionnaire (SGRQ) which is disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scaling includes Part
1: (Symptoms) frequency \& severity with 1, 3 or 12-month recall (best performance with 3- and 12-month recall) Part 2: (Activity and Impacts) Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Validity include significant correlations between total score and presence of cough, sputum, and wheeze
Measured: 8 weeks
Breathlessness, Cough and Sputum Scale (BCSS)
The Sputum Diary will be assessed using the Breathlessness, Cough and Sputum Scale (BCSS). This scale consists of three items that patients report on: breathlessness, cough, and sputum. Participants rate each symptom on a 5-point Likert scale ranging from 0 to 4, where higher scores indicate more severe symptoms. The total score ranges from 0 to 12 The scale has been validated for its reliability and validity, and its suitability for measuring the errors associated with BCSS has been examined. Internal consistency and reproducibility (test-retest reliability) were assessed using Cronbach's alpha coefficient. Discriminant validity was tested using two methods: analysis of variance (ANOVA) with post Hoc Scheffé test to determine variations in BCSS scores based on disease severity levels
Measured: 8 weeks
Modified Borg Dyspnea Scale
Modified Borg Dyspnea scale, a reliable and valid tool, will be used to report the intensity of Dyspnea related symptoms experienced by patients. Modified Borg Scale: 11-point scale ranges from 0 (no dyspnea to 10 (max dyspnea). It has been found it has been shown to be reliable for quantifying dyspnea in trial patients
Measured: 8 weeks
Secondary outcomes (1)
Digital Spirometer
Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time. Spirometry is a diagnostic test of several common respiratory disperses such as asthma and chronic obstructive pulmonary disease (COPD).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
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 Chronic Obstructive Pulmonary DiseaseStudies 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, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- iram nawaz, mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065162
- Sponsor's protocol ID
- REC/RCR & AHS/24/0354
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang W, Li F, Li C, Meng J, Wang Y. Focus on Early COPD: Definition and Early Lung Development. Int J Chron Obstruct Pulmon Dis. 2021 Nov 25;16:3217-3228. doi: 10.2147/COPD.S338359. eCollection 2021.
PubMed 34858022Melam GR, Zakaria A, Buragadda S, Sharma D, Alghamdi MA. Comparison of Autogenic Drainage & Active Cycle Breathing Techniques on FEV1, FVC & PERF in Chronic Obstructive Pulmonary Disease. World Applied Sciences Journal. 2012;20(6):818-22.
Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
PubMed 22100537Sandelowsky H, Weinreich UM, Aarli BB, Sundh J, Hoines K, Stratelis G, Lokke A, Janson C, Jensen C, Larsson K. COPD - do the right thing. BMC Fam Pract. 2021 Dec 11;22(1):244. doi: 10.1186/s12875-021-01583-w.
PubMed 34895164Cai S, Yao J, Han M, Luo X, Yu Y, Lu X, Xiang X, Huang L. The effect of cognition in combination with an ACBT on dyspnea-related kinesiophobia in patients with moderate to severe COPD: Quasirandomized controlled trial study. Geriatr Nurs. 2024 Mar-Apr;56:138-147. doi: 10.1016/j.gerinurse.2024.01.002. Epub 2024 Feb 10.
PubMed 38342002
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Subtle Touch Technique and Active Cycle of Breathing Technique in COPD
- ClinicalTrials.gov ID
- NCT07065162
- Acronym / sponsor ID
- REC/RCR & AHS/24/0354
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 15 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.
COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. Subtle Touch, also known as Calatonia, involves a profound relaxation approach that regulates muscle tension and fosters physical and psychological equilibrium in patients. The study will employ a randomized controlled trial, with total 40 participants divided into two groups. Group A will receive ACBTs three times daily for fifteen minutes for eight weeks. Group B will receive ACBT along with subtle touch technique for three times daily for fifteen minutes for eight weeks. The nonprobability convenient sampling technique, followed by random allocation using sealed opaque enveloped method.The inclusion criteria will be focusing on patients of 45 to 60 years of age, patients with mild to moderate COPD (according to Gold Criteria) and both male and female. While exclusion criterion includes musculoskeletal disorders, any recent chest injuries, lung infections and pulmonary hypertension. The methodology will involve 8-week intervention period, conducted at pulmonology department of Jinnah hospital, with participants in each group receiving instruction and support in their respective breathing techniques. All patients will be assessed using Digital Spirometer (to evaluate pulmonary functions), Breathlessness Cough and Sputum Scale BCSS (to evaluate sputum diary of patients), Modified Borg Dyspnea Scale and St. George's Respiratory Questionnaire (SGRQ). The data analysis will be done by using SPSS version 25. After assessing Combined Effects of ACBT and Subtle Touch Technique in COPD normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Detailed description
COPD is a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. In 2018, approximately 5.1% of adults (equivalent to around 12.8 million individuals) received a COPD diagnosis. Subtle Touch, also known as Calatonia, involves a profound relaxation approach that regulates muscle tension and fosters physical and psychological equilibrium in patients. It entails gentle stimulation of nerve receptor-rich areas of the body, promoting muscle relaxation and potentially improving respiratory muscle function. The study will employ a randomized controlled trial, with total 40 participants divided into two groups. Group A will receive ACBTs three times daily for fifteen minutes for eight weeks.
Group B will receive ACBT along with subtle touch technique for three times daily for fifteen minutes for eight weeks. The nonprobability convenient sampling technique, followed by random allocation using sealed opaque enveloped method, ensures a diverse yet unbiased sample. The inclusion criteria will be focusing on patients of 45 to 60 years of age, patients with mild to moderate COPD (according to Gold Criteria) and both male and female. While exclusion criterion includes musculoskeletal disorders, any recent chest injuries, lung infections and pulmonary hypertension. The methodology will involve 8-week intervention period, conducted at pulmonology department of Jinnah hospital, with participants in each group receiving instruction and support in their respective breathing techniques. All patients will be assessed using Digital Spirometer (to evaluate pulmonary functions), Breathlessness Cough and Sputum Scale BCSS (to evaluate sputum diary of patients), Modified Borg Dyspnea Scale and St. George's Respiratory Questionnaire (SGRQ). The data analysis will be done by using SPSS version 25. After assessing
1 Combined Effects of ACBT and Subtle Touch Technique in COPD normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subtle Touch Technique with Active Cycle of Breathing Technique | Experimental | Other: Subtle Touch TechniqueGroup A will receive 3 cycles of ACBT along with subtle touch technique for 15 minutes 3 times daily for 8 weeks, in addition to the standard COPD care and medication. |
| Active Cycle of Breathing Technique | Active comparator | Other: Active Cycle of Breathing TechniqueGroup B will receive 3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45 to 65
- Patients with mild to moderate COPD (according to Gold Criteria)
- Both male and female (18).
Key exclusion criteria (4 listed)
- Musculoskeletal disorders
- Any recent chest injuries
- Lung infections
- Pulmonary hypertension (18)
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 |
|---|---|---|
| Subtle Touch TechniqueAlso: Active Cycle of Breathing Technique3 cycles of ACBT along with subtle touch technique for 15 minutes 3 times daily for 8 weeks, in addition to the standard COPD care and medication. | Other | Subtle Touch Technique with Active Cycle of Breathing Technique |
| Active Cycle of Breathing Technique3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication. | Other | Active Cycle of Breathing Technique |
Primary outcome
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 8 weeks
Patients were assessed through the help of Saint George respiratory Questionnaire (SGRQ) which is disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scaling includes Part 1: (Symptoms) frequency \& severity with 1, 3 or 12-month recall (best performance with 3- and 12-month recall) Part 2: (Activity and Impacts) Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Validity include significant correlations between total score and presence of cough, sputum, and wheeze
Breathlessness, Cough and Sputum Scale (BCSS)
Time frame: 8 weeks
The Sputum Diary will be assessed using the Breathlessness, Cough and Sputum Scale (BCSS). This scale consists of three items that patients report on: breathlessness, cough, and sputum. Participants rate each symptom on a 5-point Likert scale ranging from 0 to 4, where higher scores indicate more severe symptoms. The total score ranges from 0 to 12 The scale has been validated for its reliability and validity, and its suitability for measuring the errors associated with BCSS has been examined. Internal consistency and reproducibility (test-retest reliability) were assessed using Cronbach's alpha coefficient. Discriminant validity was tested using two methods: analysis of variance (ANOVA) with post Hoc Scheffé test to determine variations in BCSS scores based on disease severity levels
Modified Borg Dyspnea Scale
Time frame: 8 weeks
Modified Borg Dyspnea scale, a reliable and valid tool, will be used to report the intensity of Dyspnea related symptoms experienced by patients. Modified Borg Scale: 11-point scale ranges from 0 (no dyspnea to 10 (max dyspnea). It has been found it has been shown to be reliable for quantifying dyspnea in trial patients
1 secondary outcome
Digital Spirometer
Time frame: 8 weeks
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 15 Jul 2025.
- Background: PubMed 34858022Yang W, Li F, Li C, Meng J, Wang Y. Focus on Early COPD: Definition and Early Lung Development. Int J Chron Obstruct Pulmon Dis. 2021 Nov 25;16:3217-3228. doi: 10.2147/COPD.S338359. eCollection 2021.
- BackgroundMelam GR, Zakaria A, Buragadda S, Sharma D, Alghamdi MA. Comparison of Autogenic Drainage & Active Cycle Breathing Techniques on FEV1, FVC & PERF in Chronic Obstructive Pulmonary Disease. World Applied Sciences Journal. 2012;20(6):818-22.
- Background: PubMed 22100537Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
- Background: PubMed 34895164Sandelowsky H, Weinreich UM, Aarli BB, Sundh J, Hoines K, Stratelis G, Lokke A, Janson C, Jensen C, Larsson K. COPD - do the right thing. BMC Fam Pract. 2021 Dec 11;22(1):244. doi: 10.1186/s12875-021-01583-w.
- Background: PubMed 38342002Cai S, Yao J, Han M, Luo X, Yu Y, Lu X, Xiang X, Huang L. The effect of cognition in combination with an ACBT on dyspnea-related kinesiophobia in patients with moderate to severe COPD: Quasirandomized controlled trial study. Geriatr Nurs. 2024 Mar-Apr;56:138-147. doi: 10.1016/j.gerinurse.2024.01.002. Epub 2024 Feb 10.
- Individual participant dataSharing planned: No
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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.
iram nawaz, mphill 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 Subtle Touch Technique and Active Cycle of Breathing Technique in people with Chronic Obstructive Pulmonary Disease, 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 3 inclusion and 4 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 15 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.du.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
St. George's Respiratory Questionnaire (SGRQ) (time frame: 8 weeks). 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 NCT07065162, 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 15 Jul 2025.