NCT06537479

Brief Summary

The study aims to evaluate the effects of Buteyko breathing techniques with and without chest wall mobilization on pulmonary functions, and quality of life in chronic smokers. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS \& AHS. A non-probability convenient sampling technique will be used to recruit the individuals. Group 1-Buteyko breathing technique + Chest Wall Mobilization and Group 2-Buteyko Breathing Technique + Without Chest Wall Mobilization

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 13, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 24, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Buteyko Breathing Technique, Chest wall Mobilization

Outcome Measures

Primary Outcomes (3)

  • FEV1(Forced Expiratory Volume per second)

    Pulmonary Function Test using Digital Spirometer. • Forced Vital Capacity (FVC): the amount of air that can be forcefully exhaled after taking a complete breath.

    Pre and Post after 1 week

  • FVC(Forced Vital Capacity)

    Pulmonary Function Test using Digital Spirometer. the amount of air expelled during the first second of the forced ventilation test (FVC), which measures how rapidly the lungs can empty.

    Pre and Post after 1 week

  • St George Questionnaire

    To assess the Quality of Life. The total questionnaire score is 100 (highest impairment) while the subscale values range from zero (no impairment)

    Pre and Post after 1 week

Study Arms (2)

Buteyko breathing technique, Chest wall mobilization

EXPERIMENTAL

Deep breathing exercises for 5 minutes. After the 5-minute resting interval Buteyko breathing technique and chest wall mobilization of 5 minutes Chest wall mobilization with 8-10 repetitions. Total time duration will be 30 minutes. 2 sessions per week

Other: Buteyko breathing techniqueOther: Chest Wall Mobilization

Buteyko breathing technique

ACTIVE COMPARATOR

Deep breathing for 5 minutes as a baseline Buteyko technique of 2 sets of 8-10 repetitions for 2 days a week. Chest wall mobilization will not be included in Group 2. Repeat the breathing cycle for 5-10 minutes, 2-3 times a day. Total time duration will be 30 minutes.

Other: Buteyko breathing technique

Interventions

Participants will be advised to sit in a comfortable and relaxed position and take a shallow breath through nose, partially filling the lungs. Hold breath for 2-3 seconds and exhale slowly through the nose and emptying the lungs.

Buteyko breathing techniqueButeyko breathing technique, Chest wall mobilization

It started with positioning, sitting or standing with good posture, and relaxing shoulders and arms. Hands were placed on the chest with fingers wide and thumbs on side of ribcage. Inhale deep breaths with expansion of chest and hands move outward. Exhale slowly allowed the chest to drop and the hands to move inward.

Buteyko breathing technique, Chest wall mobilization

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female participants were included
  • The age of participants was 40 -55 years.
  • Individuals who fulfilled the criteria of smoking which is calculated by multiplying the number of packs smoked per day by the number of years smoked were included.
  • Individuals who are current smokers or history of long-term smoking were included.
  • Predicted values FEV1 \< 75% and FEV1/FVC \<70%

You may not qualify if:

  • Participants with neurological disorders were excluded
  • Participants with musculoskeletal disorders were excluded as it affects the physical activity of the 6-minute walk test.
  • Participants having any pulmonary complications or lung disease were excluded.
  • Participants previously involved in any other exercise or physical activity were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Tasneem Shehzadi, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kinza Saleem, DPT

CONTACT

Tasneem Shahzadi, TDPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

August 5, 2024

Study Start

June 13, 2024

Primary Completion

August 13, 2024

Study Completion

September 10, 2024

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations