Effects of Subtle Touch Technique and Active Cycle of Breathing Technique

NCT07065162 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0354
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  8 weeks

Secondary Outcomes (1)

• Digital Spirometer

  8 weeks

Study Arms (2)

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.

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.

Other: Active Cycle of Breathing Technique

Interventions

Subtle Touch Technique 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.

Also known as: Active Cycle of Breathing Technique

Subtle Touch Technique with Active Cycle of Breathing Technique

Active Cycle of Breathing Technique OTHER

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

Active Cycle of Breathing Technique

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 34858022 BACKGROUND

• 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.

  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.

  PMID: 22100537 BACKGROUND

• 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.

  PMID: 34895164 BACKGROUND

• 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.

  PMID: 38342002 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• iram nawaz, mphill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phD

CONTACT

03324390125; imran.amjad@riphah.du.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 15, 2025
• Study Start: June 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)