NCT06479902

Brief Summary

This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 7, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Thoracic Kyphosis Angle

    Measured with Inclinometer

    18 days

  • Diaphragmatic Excursion

    Measured using Tape method

    18 days

  • Chest Expansion

    Measured using Tape method

    18 days

  • FEV1/FVC ratio

    Measured using Spirometer

    18 days

  • Quality of Life of patient

    Asthma Quality of Life Questionnaire with Standardized Activities. It is a 32-item Likert-type scale that measures the impact of asthma on daily activities, with scores ranging from 1 (severe impairment) to 7 (no impairment).

    18 days

Study Arms (1)

Core stabilization and Diaphragmatic Exercise Group

EXPERIMENTAL

The intervention consisted of 18 sessions over three weeks, following the FITT protocol. Each session included a warm-up (5 minutes), core stability exercises (15 minutes), diaphragmatic strengthening exercises (10 minutes), and cool-down (5 minutes), with rest intervals. Exercises progressed in difficulty on stable surfaces, tailored to each participant's tolerance. Warm-up exercises included activities like hopping and knee circles, while core stability exercises featured moves such as planks and side planks. Diaphragmatic exercises included diaphragmatic breathing in various positions.

Procedure: Core stability exerciseProcedure: Diaphragmatic Strengthening Exercise

Interventions

Core stability exercises featured moves such as planks and side planks.

Core stabilization and Diaphragmatic Exercise Group

. Diaphragmatic exercises included diaphragmatic breathing in various positions.

Core stabilization and Diaphragmatic Exercise Group

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group: 18-34 years old
  • Both males and females
  • Individuals diagnosed with well controlled mild intermittent asthma or mild persistent asthma, at least six months prior based on referral from pulmonologist.
  • Individuals who have weak core muscles
  • Participating to the study in a voluntary basis

You may not qualify if:

  • Level 3 and above asthmatics or status asthmaticus
  • Any congenital deformities of chest wall
  • Demonstrated neuromuscular or neurological deficit/disease of chest wall.
  • Cardiopulmonary diseases including coronary artery disease, heart failure NYHA classification, valvular heart disease, cardiomyopathy, arrythmias, interstitial lung disease, COPD, pulmonary embolism, pulmonary hypertension, cancers, etc.
  • Any recent cardiothoracic or abdominal surgery or sternotomy
  • Recent history of the blunt chest wall or abdominal trauma
  • Unstable hemodynamic parameters (arterial pressure \>140mmhg systolic and \>90mmhg for diastolic
  • Pregnancy
  • Previous or parallel participation in interventional programs
  • Any psychiatric illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi Interventional Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 28, 2024

Study Start

July 15, 2023

Primary Completion

April 18, 2024

Study Completion

May 24, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations