NCT07103512

Brief Summary

To determine the additional effects of scalene hold relax technique with conventional exercises on pulmonary function in asthma patients

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable asthma

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

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

July 29, 2025

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Asthma Control Questionnaire

    A simple questionnaire Objective to measure the adequacy of asthma control and change in asthma control which occur either spontaneously or as a result of treatment ACQ has multidimensional construct assessing symptoms (5 items -self-administering and rescue in bronchodilator use (1 item-self-administered and FEV1%(1 item completed by clinic staff Test Retest reproducibility Reported with high intraclass correlation coefficient =0.90 Internal Consistency yes 7 point scale (0=no impairment =6 maximum impairment for symptoms and rescue use and 7categories for FEV1%) Minimally imp difference Change in score 0.5 7 items (score Range 0 (Totally controlled and 6 Severely Uncontrolled)

    4 week

  • Asthma Control Test

    A patient self-administered tool for identifying those with poorly controlled asthma assess the frequency of shortness of breath and general asthma The Score Range from 5 (poor control of asthma) to 25 complete control of asthma) with higher scores reflecting greater asthma control. 5 items with 4-week recall on symptoms and daily functioning 5-point scale for symptom and activities 1=not controlled at all 5= completely controlled

    4 week

  • Lara Asthma Symptoms Scale

    The Lara Asthma Symptom Scale (LASS) is a validated tool designed to assess asthma symptoms in adults. It comprises eight questions that evaluate the frequency of various asthma-related symptoms over the past four weeks. Each question is scored on a 5-point Likert scale, where higher scores indicate more frequent symptoms. To interpret the LASS, sum the scores from all eight questions to obtain a total score ranging from 0 to 32. Higher total scores indicate more frequent and severe asthma symptoms, suggesting poorer asthma control.

    4 week

  • FEV1

    Forced Expiratory Volume in 1 second, is a measurement of how much air a person can forcefully exhale from their lungs in one second.

    4 week

  • FVC

    Forced Vital Capacity, is a measurement of lung function assessed during spirometry. t represents the maximum amount of air that can be forcefully exhaled after a full inhalation.

    4 week

  • PEF

    Peak Expiratory Flow) spirometer, often a simple peak flow meter, is a device used to measure the speed of air exhaled from the lungs.

    4 week

Study Arms (2)

Scalene Hold Relax Technique

EXPERIMENTAL

Scalene Hold Relax Technique Scalene Hold for 10 Second 10 Repetition. Hold your arms behind your back to keep them from rising then slowly tilt your head trying to touch your ear to your shoulder. Bend your neck only as far as it is comfortable, and hold for 5 to 10 seconds. Relax your neck and repeat 2-3 times on each side. The treatment will be provided for 1-4 weeks as per need

Other: Scalene Hold Relax Technique

Conventional physical Therapy

ACTIVE COMPARATOR

Diaphragmatic Breathing Exercise Inhale through nose about 4 Seconds, hold Breath for 2 Seconds, repeat 5 times, exercise repeated for 2-3 days per week followed up to 4 weeks. \+ Buteyko Breathing Exercise Exhale slowly and then hold that breath. Use index figure and thumb to plug nose hold that breath until there is an urge to breathe and then inhale Breathe normally at least 10 second repeat several. Frequency 2-3 days per week with Moderate Intensity follow-up to 4weeks

Other: Conventional Physical Therapy

Interventions

Scalene Hold Relax Technique Scalene Hold for 10 Second 10 Repetition. Hold your arms behind your back to keep them from rising then slowly tilt your head trying to touch your ear to your shoulder. Bend your neck only as far as it is comfortable, and hold for 5 to 10 seconds. Relax your neck and repeat 2-3 times on each side. The treatment will be provided for 1-4 weeks as per need

Scalene Hold Relax Technique

Diaphragmatic Breathing Exercise Inhale through nose about 4 Seconds, hold Breath for 2 Seconds, repeat 5 times, exercise repeated for 2-3 days per week followed up to 4 weeks. \+ Buteyko Breathing Exercise Exhale slowly and then hold that breath. Use index figure and thumb to plug nose hold that breath until there is an urge to breathe and then inhale Breathe normally at least 10 second repeat several. Frequency 2-3 days per week with Moderate Intensity follow-up to 4weeks

Conventional physical Therapy

Eligibility Criteria

Age22 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient diagnosed with Allergic asthma
  • Both male and female will be included
  • Age between 20 to 44 years.

You may not qualify if:

  • Patient who do not provide consent
  • Patient with any comorbid condition such as cardiovascular disease diabetes or other chronic illness
  • Patient with any psychological condition that may interfere with participation or adherence to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital

Mānsehra, Khyber PkahtoonKhwa, 21300, Pakistan

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq, PhD*

CONTACT

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

July 29, 2025

First Posted

August 5, 2025

Study Start

August 21, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations