NCT04624425

Brief Summary

To determine the effects of segmental breathing exercise and buteyko breathing exercises on chest expansion in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on pulmonary function (FEV1, FVC, FEV1/FVC) in individuals with asthma. To determine the effects of segmental breathing exercise and buteyko breathing exercises on Asthma Control Questionnaire in individuals with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable asthma

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 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

November 5, 2020

Last Update Submit

January 12, 2021

Conditions

Keywords

AsthmaSegmental Breathing

Outcome Measures

Primary Outcomes (7)

  • Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    2 weeks

  • Forced vital Capacity (FVC)

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.

    2 weeks

  • Modified Borg Scale of Perceived Exertion

    Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.

    2 weeks

  • Chest Expansion measurement at Axillary level

    A measuring tape with centimeters scale will be used for measuring the expansion at Axillary level. Changes from the baseline will be measured.

    2 weeks

  • Chest Expansion measurement at Spinal cord T4 level

    A measuring tape with centimeters scale will be used for measuring the expansion at at Spinal cord T4 level. Changes from the baseline will be measured.

    2 weeks

  • Chest Expansion measurement at xiphoid process

    A measuring tape with centimeters scale will be used for measuring the expansion at xiphoid process level. Changes from the baseline will be measured.

    2 weeks

  • Asthma Control Questionnaire

    Measurement of the adequateness of asthma control and modifications in asthma control which may occurs immediately or as a consequence of treatment. It is a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled) .The 7-items Asthma Control Questionnaire (ACQ) is valid to measure the goals of asthma management as defined by international guideline. Changes from the baseline will be measured.

    2 weeks

Study Arms (2)

Segmental breathing exercises

EXPERIMENTAL

Segmental breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks

Other: Segmental breathing exercises

Buteyko breathing exercises

ACTIVE COMPARATOR

Buteyko breathing exercises, Treatment session will be last for 10-15 minutes. For 2 Weeks

Other: Buteyko breathing exercises

Interventions

Segmental breathing exercises along with the Conventional Treatment of buteyko breathing exercises for two weeks of duration. Segmental breathing exercises include 18-20 breaths in one session (6 breaths/min) with rest interval after every 6 breaths.

Segmental breathing exercises

Buteyko exercises for two weeks of duration. Treatment session will be last for 10-15minutes.

Buteyko breathing exercises

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with clinical diagnosis of asthma.

You may not qualify if:

  • Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax.
  • Participants with pleura disorder and chest trauma \& rib fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nusrat Abdul Rauf Centre for Enablement (NACE)

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Iqbal Tariq, MSPT-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 10, 2020

Study Start

September 9, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations