## Protocol Section
### Identification Module
**NCT ID:** NCT06426849

**Brief Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Asthma

**Official Title:** Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Improving Dyspnea Index and Pulmonary Function in Patients With Asthma

#### Organization Study ID Info
**ID:** Maria Akbar
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Riphah International University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** To analyze either Liuzijue exercise or Tai Chi Chuan exercise is effective in improving dyspnea index and pulmonary function in patients with asthma. In the general population, the rate of asthma is increasing day by day because of environmental and occupational risk factors which is becoming a burden. It causes shortness of breath, decreases lung volume, and disturbs quality of life. This study aims to improve dyspnea index, lung volume and quality of life of the patients with asthma.

**Detailed Description:** Liuzijue Exercise is the most popular exercise in ancient Chinese literature which is compiled by the Chinese Qigong Management Centre. Liuzijue exercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, ("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities. It is very helpful to improve pulmonary functions, exercise capacity, and quality of life of patients with pulmonary disease.

Liuzijue exercise takes on the backward abdominal breathing technique joined with physical exercises, which can practice the diaphragm and chest auxiliary respiratory muscles. Hence, the patient's breathing time is extended, and the breathing profundity increments. To accomplish the reason for expanding the gas exchange rate of the lungs and enhancing the lung capacity. Tai Chi Chuan is a traditional Chinese Exercise that is significant in improving the pulmonary functions of asthmatic patients.

Tai Chi (10 forms of yang style ) significantly improves the exercise capacity of patients with lung disease. Tai Chi seems to have physiologic and psychosocial benefits and appears to be protected and viable in advancing balance control, adaptability, and cardiovascular fitness for older adults.

### Conditions Module

**Conditions:**

- Asthma

**Keywords:**

- Liuzijue exercise

- Tai Chi Chuan exercise

- Dyspnea Index

- Pulmonary Function

- Asthma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** LiuzijueExercise will be performed by delivering 6 distinct sounds,("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities.

**Intervention Names:**

- Other: Liuzijue Exercise

**Label:** GROUP A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 10 FORM OF YANG NG STYLE Tai Chi Chuan Exercise that combines deep diaphragmatic breathing and relaxation with many fundamental postures.

**Intervention Names:**

- Other: Tai Chi Chuan Exercise

**Label:** GROUP B

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GROUP A

**Description:** LiuzijueExercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, (xū,hē, hū sī, chuī, and xī) through termination along with comparing body activities.

The following are 6-8 vital parts of body movements:

1. Swaying and twisting
2. Hip rotations
3. Arm movements
4. Knee bends
5. Foot pivots
6. Spine elongation
7. Hand gestures
8. Breath synchronization Frequency: 1 session per day for a week Intensity:In first week 1 set of Luizijue exercise will be performed then progressively increase to 4 sets till 6th week .

Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Luizijue Exercise.

**Name:** Liuzijue Exercise

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- GROUP B

**Description:** Tai Chi Chuan Exercise combines deep diaphragmatic breathing and relaxation with many fundamental postures.

Names of the 10 Movements in Sequence

1. Commencing Form
2. Repulsing the Monkey
3. Brush Knee
4. Parting the Horse's Mane
5. Cloud Hands
6. Golden Cockerel Standing on the Left, then the Right
7. Kick Out Right, Kick Out Left
8. Grasping the Bird's Tail
9. Cross Hands or Embrace the Tiger
10. Closing Form Frequency: 3 sessions / week Intensity: Initially each posture will be performed 3 times then progressively leads to 6 or 10 reps according to patient tolorance.

Total Time for Session; 40 minutes Warm-up Time: 10 minutes with pursed lip breathing Cool Down Time: 10 minutes with upper body gentle stretching. Exercise Duration: 20 minutes for Tai Chi Chuan Exercise.

**Name:** Tai Chi Chuan Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** From baseline till 2nd, 4th, and 6th week measured throug Modified Medical Research Council (mMRC) dyspnoea scale. It is a self-rating scale to quantify the level of incapacity that breathlessness presents on everyday activity on a scale from Grade 0 to 4.

Grade 0: No shortness of breath besides on exhausting activity Grade1: Breathlessness while hustling fair and square or strolling along a slight slope Grade 2: Strolls more slow than individuals of same age fair and square in light of shortness of breath or needs to stop to take breath while strolling at their own speed fair and square Grade 3: Stop for breath subsequent to strolling ∼100 m or following couple of moments fair and square.

Grade 4: Excessively breathless to take off from the house, or breathless while dressing or stripping down

**Measure:** Dyspnea index

**Time Frame:** 6 weeks

**Description:** Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze

**Measure:** Forced Expiratory Volume in 1 second (FEV1)

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** From baseline till 6th week measured through Asthma Control Questionnaire that individuals answer in regards to the recurrence of asthma symptoms over 6 weeks.

Each answer has a numeric value. The asthmatic individual adds their score to decide their degree of asthma symptoms control. Score ranges from 5 to 25. A score 20 to 25 indicate well controlled asthma while score ranges between 5 to 6 indicated poor controlled asthma.

**Measure:** Asthma Quality of life

**Time Frame:** 6 Weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Diagnosed case of Asthma for last 6 months Patients with mild to moderate asthma On spirometry FEV1/FVC ratio less than 70% MRC- Grade 2 and 3

Exclusion Criteria:

Refusal to consent. Unstable vitals. Diagnosed with COPD, pulmonary edema, acute or chronic pneumonia or other lung disease.

Untreated Hypertension. Diagnosed Tumor. Patient with Stroke and other neurological conditions. Patient with active Tuberculosis or other infectious disease. Patients with history of heart failure or any other cardiovascular condition

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mehwish.waseem@riphah.edu.pk

**Name:** Mehwish Waseem, MSPT-CPPT

**Phone:** 0331-5309015

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chichawatni

**Contacts:**

***Contact 1:***

- **Email:** mehwish.waseem@riphah.edu.pk

- **Name:** Mehwish Waseem, MSPT-CPPT

- **Phone:** 0331-5309015

- **Role:** CONTACT

***Contact 2:***

- **Email:** mariaakbar732@gmail.com

- **Name:** Maria Akbar, MSPT-CPPT*

- **Phone:** 0345-5024803

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Tehsil Headquarter Hospital

**State:** Punjab

**Status:** RECRUITING

**Zip:** 57200

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University

**Name:** Mehwish Waseem, MSPT-CPPT

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M7591

- Name: Dyspnea

- Relevance: LOW

- As Found: Unknown

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-31
