NCT07389291

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

26 days

First QC Date

January 15, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

Femoral Neck FracturesQi GongGood Health and Well-BeingAged

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Pre-test), Week 2, Week 4

Secondary Outcomes (2)

  • Change in Systolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer

    Baseline (Pre-test), Week 2, Week 4

  • Change in Diastolic Blood Pressure (mmHg) measured using Digital Sphygmomanometer

    Baseline (Pre-test), Week 2, Week 4

Study Arms (2)

Liuzijue Qi Gong Exercise Group

EXPERIMENTAL
Other: Liuzijue Qi Gong Exercise

Box Breathing Technique Group

ACTIVE COMPARATOR
Other: Box Breathing Technique

Interventions

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.

Also known as: Six Character Qi Gong
Liuzijue Qi Gong Exercise 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.

Also known as: Four-Square Breathing
Box Breathing Technique Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saveetha Medical College and Hospital (SMCH)

Chennai, Tamil Nadu, 602105, India

Location

Related Publications (5)

  • 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.

    PMID: 27260196BACKGROUND
  • Zaliene 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.

    PMID: 41439857BACKGROUND
  • Gouzoulis 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.

    PMID: 40388471BACKGROUND
  • Feng 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.

    PMID: 32425471BACKGROUND
  • 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.

    PMID: 35093513BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Shenbaga Sundaram Subramanian

    Saveetha college of physiotherapy, Saveetha Institute of Medical and Technical Sciences [SIMATS].

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 5, 2026

Study Start

September 1, 2025

Primary Completion

September 27, 2025

Study Completion

October 20, 2025

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations