- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389291
Effect of Liuzijue and Box Breathing on Inspiratory Capacity and Blood Pressure After Femoral Neck Fracture Immobilization
Effectiveness of Liuzijue and Box Breathing Techniques on Inspiratory Capacity and Blood Pressure Following Femoral Neck Fracture Immobilization: A Retrospective Comparative Study
The purpose of this study is to understand how two simple breathing exercise techniques (Liuzijue and box breathing) affect inspiratory capacity and blood pressure in people who were immobilized after a femoral neck fracture.
Older adults who sustain a femoral neck fracture are often required to remain immobile for several weeks. Prolonged immobilization can reduce lung capacity and may negatively affect blood pressure control, increasing the risk of breathing difficulties and other health problems. Breathing-based exercise techniques may help improve respiratory function and cardiovascular stability during recovery.
This study retrospectively analyzed data from patients who had previously received either Liuzijue exercises or box breathing techniques as part of their rehabilitation program. The main questions this study aimed to answer were:
Do Liuzijue and box breathing techniques improve inspiratory capacity after a period of immobilization? Do these techniques help in controlling systolic and diastolic blood pressure? Is one technique more effective than the other over a 4-week intervention period?
Data were collected at three time points: before the intervention (baseline), at the second week, and at the end of the fourth week. The findings of this study may help healthcare professionals choose simple, safe, and cost-effective breathing interventions for patients recovering from femoral neck fractures.
Study Overview
Status
Intervention / Treatment
Detailed Description
Femoral neck fractures are common in the elderly population and are frequently associated with prolonged periods of immobilization. Extended immobilization can lead to reduced lung volumes, impaired inspiratory capacity and alterations in blood pressure regulation due to decreased physical activity and respiratory muscle disuse. These changes increase the risk of respiratory complications and cardiovascular instability during recovery.
Liuzijue is a traditional breathing-based exercise that combines slow, controlled breathing with specific vocalized exhalation patterns. It has been shown to improve respiratory muscle function, lung volumes and autonomic regulation. Box Breathing is a simple, structured breathing technique involving equal phases of inhalation, breath-holding, exhalation, and breath-holding and is known to promote relaxation and cardiovascular stability through autonomic nervous system modulation.
This retrospective study analyzed data from patients who had undergone a 4-week breathing-based intervention program following immobilization due to femoral neck fracture. Participants were divided into two groups based on the intervention they received: the Liuzijue exercise group and the Box Breathing technique group. Both interventions were administered for 20 minutes per session, twice daily, six days per week, over a period of four weeks as part of routine physiotherapy care.
Inspiratory capacity was measured using a volume-oriented incentive spirometer, while blood pressure parameters, including systolic and diastolic blood pressure, were recorded using a Digital sphygmomanometer. Outcome measures were documented at baseline (prior to intervention), at the end of the second week and at the completion of the fourth week.
The primary outcome of the study was the change in inspiratory capacity over the intervention period. Secondary outcomes included changes in systolic and diastolic blood pressure. Data were analyzed to evaluate within-group improvements over time and to compare the effectiveness of Liuzijue and Box Breathing techniques.
The findings of this study aim to provide evidence regarding the effectiveness of simple, non-invasive breathing-based interventions in improving respiratory function and blood pressure control in elderly individuals recovering from femoral neck fracture immobilization. The results may assist clinicians in selecting appropriate respiratory rehabilitation strategies for this population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tamil Nadu
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Chennai, Tamil Nadu, India, 602105
- Saveetha Medical College and Hospital (SMCH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged between 65-85 years
- Femoral neck fracture managed conservatively or surgically.
- Volume-oriented incentive spirometer level less than 1000ml
- Blood pressure between 130/85 mmHg and 150/95 mmHg, not on regular antihypertensive medications
- Minimum 2 weeks of immobilization following the fracture.
- Ability to understand instructions and follow simple exercise routines.
- Ability to provide informed consent.
Exclusion Criteria:
- Recent major surgery (other than the femoral fracture)
- Severe hearing or speech impairment
- Uncontrolled hypertension (BP > 150/95 mmHg)
- Use of supplemental oxygen at rest
- Cognitive impairment
- History of cardiovascular events in the past 6 months
- History of recurrent syncope or dizziness
- Severe uncontrolled pain in the lower limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Liuzijue Qi Gong Exercise Group
|
Liuzijue Qi Gong is a gentle breathing exercise from traditional Chinese medicine.
It involves six specific vocal sounds ("Xu", "He", "Hu", "Si", "Chui", and "Xi").
The practice promotes deep, diaphragmatic breathing, improves lung function and supports relaxation.
Participants performed Liuzijue Qi Gong exercises for 20 minutes, twice daily, 6 days per week, for 4 weeks following femoral neck fracture.
Other Names:
|
|
Active Comparator: Box Breathing Technique Group
|
Box Breathing is a controlled breathing exercise that involves four equal phases: inhale, hold, exhale, hold, typically performed for 4-6 seconds each.
It helps regulate breathing, reduce stress, improve oxygenation, and enhance autonomic balance.
Safely practiced by older adults or individuals with limited physical activity.
Participants performed the Box Breathing technique for 20 minutes, twice daily, 6 days per week, for 4 weeks following femoral neck fracture.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Inspiratory Capacity (mL) measured using Volume-Oriented Incentive Spirometer
Time Frame: Baseline (Pre-test), Week 2, Week 4
|
Inspiratory capacity will be quantitatively measured in milliliters (mL) using a volume-oriented incentive spirometer.
Participants will perform three maximal slow inspiratory efforts in an upright sitting position, and the highest recorded value will be used for analysis.
Measurements will be collected using the same calibrated spirometer device for all participants to ensure consistency.
Data will be recorded as continuous numerical values in milliliters and analyzed as within-group and between-group changes over time.
|
Baseline (Pre-test), Week 2, Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer
Time Frame: Baseline (Pre-test), Week 2, Week 4
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a calibrated digital sphygmomanometer.
Measurements will be taken with the participant in a seated position after a minimum of five minutes of rest.
Two readings will be recorded at each assessment point, and the average of the two readings will be used for analysis.
Data will be analyzed as continuous numerical values to assess changes over time.
|
Baseline (Pre-test), Week 2, Week 4
|
|
Change in Diastolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer
Time Frame: Baseline (Pre-test), Week 2, Week 4
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a calibrated digital sphygmomanometer under standardized conditions.
Two readings will be obtained at each time point, and the average value will be recorded for analysis.
Measurements will be expressed as continuous variables and compared across assessment time points.
|
Baseline (Pre-test), Week 2, Week 4
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shenbaga Sundaram Subramanian, Saveetha college of physiotherapy, Saveetha Institute of Medical and Technical Sciences [SIMATS].
Publications and helpful links
General Publications
- Xu S, Zhang D, He Q, Ma C, Ye S, Ge L, Zhang L, Liu W, Chen Z, Zhou L. Efficacy of Liuzijue Qigong in patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis. Complement Ther Med. 2022 May;65:102809. doi: 10.1016/j.ctim.2022.102809. Epub 2022 Jan 29.
- Takac M. [Professor MUDr. Frantisek Por 70 years old]. Bratisl Lek Listy. 1969;51(5):521-2. No abstract available. Slovak.
- Husberg C, Murphy P, Bjorgo E, Kalland KH, Kolsto AB. Cellular localisation and nuclear export of the human bZIP transcription factor TCF11. Biochim Biophys Acta. 2003 May 12;1640(2-3):143-51. doi: 10.1016/s0167-4889(03)00041-7.
- Lopert R, Lang DL, Hill SR, Henry DA. Differential pricing of drugs: a role for cost-effectiveness analysis? Lancet. 2002 Jun 15;359(9323):2105-7. doi: 10.1016/S0140-6736(02)08911-0.
- Maguire FW. Stevens-Johnson syndrome due to sulindac: a case report and review of the literature. Del Med J. 1981 Apr;53(4):193-7. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 065/05/2025/ISRB/PGSR/SCPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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