NCT06308289

Brief Summary

The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

March 4, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

chronic obstructive Pulmonary diseasePostureWork of breathing

Outcome Measures

Primary Outcomes (6)

  • SF- 36 Questionnaire

    The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL

    12 Weeks

  • FEV1/FVC ratio

    The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.

    12 Weeks

  • 6-minute walk test

    The Six-Minute Walk Test (6MWT) assesses exercise capacity. Participants are briefed and baseline vital signs are recorded. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    12 Weeks

  • Photogrammetry

    Photogrammetry is a research tool used in COPD studies to assess physical changes. It involves capturing and analyzing images of patients to measure anatomical features and body movement.

    12 Weeks

  • Forced expiratory volume (FEV1)

    The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.

    12 Weeks

  • Forced vital capacity (FVC)

    The individual inhales maximally and then exhales forcefully into a spirometer, measuring lung volume and airflow. The procedure may be repeated multiple times to ensure accurate and consistent results.

    12 Weeks

Study Arms (2)

Group A

EXPERIMENTAL

GPRM and ACBT

Other: Global Posture Re-educationOther: Active Cycle of Breathing Technique

Group B

ACTIVE COMPARATOR

Standard Care for COPD (ACBT)

Other: Active Cycle of Breathing Technique

Interventions

Focusing on postural correction and movement patterns

Group A

Emphasizing breathing control, thoracic expansion, and mucus clearance techniques

Group AGroup B

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 40-75 years diagnosed with stable COPD (according to GOLD guidelines).
  • Patients of both genders
  • FEV1: FVC ranging from 68 - 69%.
  • Predicted FEV1 of less than 70%.
  • Willingness to participate

You may not qualify if:

  • Acute Exacerbation of COPD
  • Participants with severe comorbidities, such as unstable cardiovascular diseases (e.g., recent myocardial infarction, uncontrolled hypertension)
  • Participants diagnosed with respiratory conditions other than COPD (such as asthma, interstitial lung disease)
  • Individuals who have undergone major thoracic or abdominal surgery within the past three months
  • Individuals with severe mental health conditions (such as uncontrolled psychosis or severe depression)
  • Pregnant or lactating individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Security Hospital

Gujranwala, Punjab Province, 52200, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Faizan Hamid, MS-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 13, 2024

Study Start

March 3, 2024

Primary Completion

June 5, 2024

Study Completion

June 15, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations