Femoral Neck FracturesNCT07389291
Effect of Liuzijue and Box Breathing on Inspiratory Capacity and Blood Pressure After Femoral Neck Fracture Immobilization
A study testing Liuzijue Qi Gong Exercise and Box Breathing Technique in people with Femoral Neck Fractures and Breathing Exercises, run by Saveetha University at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Femoral Neck Fractures, Breathing Exercises, Inspiratory Capacity
- What is being tested?
- Liuzijue Qi Gong Exercise and Box Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Saveetha Medical College and Hospital (SMCH)
Chennai, Tamil Nadu, 602105
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Liuzijue Qi Gong Exercise, Box Breathing Technique
- Keywords
- Femoral Neck Fractures, Qi Gong, Good Health and Well-Being, Aged
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liuzijue Qi Gong ExerciseOther
Also called Six Character Qi Gong
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.
Box Breathing TechniqueOther
Also called Four-Square Breathing
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.
| Study group | Role | What they receive |
|---|---|---|
| Liuzijue Qi Gong Exercise Group | Experimental | Not described Receives: Other: Liuzijue Qi Gong Exercise |
| Box Breathing Technique Group | Active comparator | Not described Receives: Other: Box Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inspiratory Capacity (mL) measured using Volume-Oriented Incentive Spirometer
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.
Measured: Baseline (Pre-test), Week 2, Week 4
Secondary outcomes (2)
Change in Systolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer
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.
Measured: Baseline (Pre-test), Week 2, Week 4
Change in Diastolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer
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.
Measured: Baseline (Pre-test), Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Sep 2025
- Primary completion27 Sep 2025
- Study completion20 Oct 2025
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 Femoral Neck FracturesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saveetha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srivatsan Munusamy, Saveetha University
- Investigators
- Shenbaga Sundaram Subramanian, Study director, Saveetha college of physiotherapy, Saveetha Institute of Medical and Technical Sciences [SIMATS].
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389291
- Sponsor's protocol ID
- 065/05/2025/ISRB/PGSR/SCPT
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berggren M, Stenvall M, Englund U, Olofsson B, Gustafson Y. Co-morbidities, complications and causes of death among people with femoral neck fracture - a three-year follow-up study. BMC Geriatr. 2016 Jun 3;16:120. doi: 10.1186/s12877-016-0291-5.
PubMed 27260196Zaliene L, Mockute A, Levickiene L. Breathing Interventions Improve Autonomic Function, Respiratory Efficiency and Stress in Dysfunctional Breathing: A Randomised Controlled Trial. Adv Respir Med. 2025 Dec 10;93(6):56. doi: 10.3390/arm93060056.
PubMed 41439857Gouzoulis MJ, Vasudevan RS, Kaszuba SV, Seddio AE, Rubin LE, Grauer JN, Li M. Femoral Neck Fractures: Incidence, Reasons, and Risk Factors of Conversion From Hemiarthroplasty to Total Hip Arthroplasty. J Am Acad Orthop Surg Glob Res Rev. 2025 May 13;9(5):e24.00312. doi: 10.5435/JAAOSGlobal-D-24-00312. eCollection 2025 May 1.
PubMed 40388471Feng F, Tuchman S, Denninger JW, Fricchione GL, Yeung A. Qigong for the Prevention, Treatment, and Rehabilitation of COVID-19 Infection in Older Adults. Am J Geriatr Psychiatry. 2020 Aug;28(8):812-819. doi: 10.1016/j.jagp.2020.05.012. Epub 2020 May 15.
PubMed 32425471Xu 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.
PubMed 35093513
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Liuzijue and Box Breathing Techniques on Inspiratory Capacity and Blood Pressure Following Femoral Neck Fracture Immobilization: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT07389291
- Acronym / sponsor ID
- 065/05/2025/ISRB/PGSR/SCPT
- Keywords
- Femoral Neck Fractures, Qi Gong, Good Health and Well-Being, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saveetha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 27 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 5 Feb 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liuzijue Qi Gong Exercise Group | Experimental | Other: Liuzijue Qi Gong Exercise |
| Box Breathing Technique Group | Active comparator | Other: Box Breathing Technique |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Liuzijue Qi Gong ExerciseAlso: Six Character Qi GongLiuzijue 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 | Liuzijue Qi Gong Exercise Group |
| Box Breathing TechniqueAlso: Four-Square BreathingBox 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 | Box Breathing Technique Group |
Primary outcome
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.
2 secondary outcomes
Change in Systolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 27260196Berggren M, Stenvall M, Englund U, Olofsson B, Gustafson Y. Co-morbidities, complications and causes of death among people with femoral neck fracture - a three-year follow-up study. BMC Geriatr. 2016 Jun 3;16:120. doi: 10.1186/s12877-016-0291-5.
- Background: PubMed 41439857Zaliene L, Mockute A, Levickiene L. Breathing Interventions Improve Autonomic Function, Respiratory Efficiency and Stress in Dysfunctional Breathing: A Randomised Controlled Trial. Adv Respir Med. 2025 Dec 10;93(6):56. doi: 10.3390/arm93060056.
- Background: PubMed 40388471Gouzoulis MJ, Vasudevan RS, Kaszuba SV, Seddio AE, Rubin LE, Grauer JN, Li M. Femoral Neck Fractures: Incidence, Reasons, and Risk Factors of Conversion From Hemiarthroplasty to Total Hip Arthroplasty. J Am Acad Orthop Surg Glob Res Rev. 2025 May 13;9(5):e24.00312. doi: 10.5435/JAAOSGlobal-D-24-00312. eCollection 2025 May 1.
- Background: PubMed 32425471Feng F, Tuchman S, Denninger JW, Fricchione GL, Yeung A. Qigong for the Prevention, Treatment, and Rehabilitation of COVID-19 Infection in Older Adults. Am J Geriatr Psychiatry. 2020 Aug;28(8):812-819. doi: 10.1016/j.jagp.2020.05.012. Epub 2020 May 15.
- Background: PubMed 35093513Xu 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.
- 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. This study is not recruiting at the moment.
Shenbaga Sundaram Subramanian study director
Saveetha college of physiotherapy, Saveetha Institute of Medical and Technical Sciences [SIMATS].
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liuzijue Qi Gong Exercise and Box Breathing Technique in people with Femoral Neck Fractures and Breathing Exercises, run by Saveetha University at 1 site in India.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 5 Feb 2026. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inspiratory Capacity (mL) measured using Volume-Oriented Incentive Spirometer (time frame: Baseline (Pre-test), Week 2, Week 4). 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 NCT07389291, 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 5 Feb 2026.