Effects of Subtle Touch Technique and Active Cycle of Breathing Technique

NCT ID: NCT07065162

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-01-30

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Subtle Touch Technique with Active Cycle of Breathing Technique

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.

Group Type: EXPERIMENTAL

Subtle Touch Technique

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Active Cycle of Breathing Technique

Intervention Type: OTHER

3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication.

Interventions

Subtle Touch 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.

Intervention Type: OTHER

Active Cycle of Breathing Technique

3 cycles of ACBTs technique for 15 minutes 3 times daily for 8 weeks, along with standard COPD care and medication.

Intervention Type: OTHER

Other Intervention Names

Active Cycle of Breathing Technique

Eligibility Criteria

Inclusion Criteria

• Age 45 to 65
• Patients with mild to moderate COPD (according to Gold Criteria)
• Both male and female (18).

Exclusion Criteria

• Musculoskeletal disorders
• Any recent chest injuries
• Lung infections
• Pulmonary hypertension (18)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

iram nawaz, mphill

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Gulab Devi Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

imran amjad, phD

Role: CONTACT

imran.amjad@riphah.du.pk

03324390125

Facility Contacts

Iram Nawaz, mphill

Role: primary

iram_029@yahoo.com

03324645227

References

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.

Reference Type: BACKGROUND

PMID: 34858022 (View on PubMed)

Melam 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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 22100537 (View on PubMed)

Sandelowsky 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.

Reference Type: BACKGROUND

PMID: 34895164 (View on PubMed)

Cai 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.

Reference Type: BACKGROUND

PMID: 38342002 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0354

Identifier Type: -

Identifier Source: org_study_id