NCT06463288

Brief Summary

Comparison of Jacobson Relaxation Technique and Pranayama Technique in patients with COPD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

March 4, 2024

Last Update Submit

June 12, 2024

Conditions

Keywords

COPDJacobson TechniquePranayama TechniqueSOB

Outcome Measures

Primary Outcomes (3)

  • Dyspnea Severity (Borg Scale)

    The Borg scale measures the severity of dyspnea (shortness of breath). Scale Details: Full Title: Borg Rating of Perceived Exertion (RPE) ScaleFull Title: Borg Rating of Perceived Exertion (RPE) Scale Minimum Value: 0 (No breathlessness at all) Maximum Value: 10 (Maximal breathlessness) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of dyspnea.

    4 weeks

  • Cough and Sputum Analysis (CASA-Q)

    The CASA-Q (Cough and Sputum Assessment Questionnaire) evaluates the severity and impact of cough and sputum production. Scale Details: Full Title: Cough and Sputum Assessment Questionnaire (CASA-Q) Minimum Value: 0 (No symptoms) Maximum Value: 100 (Severe symptoms) Interpretation: Higher scores indicate worse outcomes, meaning more severe symptoms of cough and sputum.

    4 Weeks

  • Spirometry (FEV1 and FVC)

    Spirometry will be used to measure lung function, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC). Scale Details: Full Title: Spirometry (FEV1 and FVC) Minimum Value: Variable (dependent on patient's lung function) Maximum Value: Variable (dependent on patient's lung function) Interpretation: Higher values typically indicate better lung function.

    4 Weeks

Secondary Outcomes (2)

  • Quality of Life (SF-36 Questionnaire)

    4 Weeks

  • Patient Satisfaction (Patient Satisfaction Questionnaire)

    4 Weeks

Study Arms (2)

Jacobson's Technique

EXPERIMENTAL

Participant in the group A were instructed to perform the Jacobson relaxation technique. * Quite place were chosen where there is no disturbance. * Patients were relax either on the lying position or sitting position with head well-supported. * Patients were instructed to loosen any tight clothing. * Patients were educated for muscles of each group emphasis on attention on that muscle group only. * Repeat this three times, constrict the muscle and then relax, tens the muscle and maintain it for five seconds then relax it lightly and then tense and relax. Constrict the muscle very slightly then relax it. Focus on each muscle group and then decide to relax the target muscle.

Procedure: Jacobsons Breathing Technique

Pranayama Technique

ACTIVE COMPARATOR

Participant in group B were instructed to perform the pranayama relaxation technique. * Quite place were chosen where there is no disturbance and patient were relaxed in sitting position with spine straight. * In this technique patients were instructed to perform different type of pranayama techniques. * Guide the participants to take a steady breath in through your both nostrils. Then inhale until you reach your total lung capacity, maintaining a tall spine. Treatment was continuous 4 weeks, 3 times in a week for 15 mint. Assessment was done through the tool before and after the treatment.

Procedure: Pranayama Technique

Interventions

Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.

Jacobson's Technique

Quality of life, cough and sputum analysis, spirometry, and shortness of breath were assessed.

Pranayama Technique

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of Age between 40 and 70.
  • Both Genders (Male, Female) were included.
  • Stage 2 patient with COPD with Dyspnea FEV1 \<70% and Maximal Expiratory Pressure = 50% (Gold Criteria) were included.
  • Cognitive Stable patients were included.
  • Those Patients were included who were clinically stable without exacerbations in the past 01 month.

You may not qualify if:

  • Common Cough
  • Upper respiratory tract inflammation
  • Patients who have other co-morbid diseases which prevents them from exercise training, for example, disability due to neurological, orthopedic and acute cardiac causes
  • Patients who were mentally and physically and sick to join at the hospital or research site for training
  • Patients who were already participated or completed or in a P.R program in the past one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulab Devi Chest Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • Pauwels RA, Buist AS, Ma P, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: National Heart, Lung, and Blood Institute and World Health Organization Global Initiative for Chronic Obstructive Lung Disease (GOLD): executive summary. Respir Care. 2001 Aug;46(8):798-825. No abstract available.

    PMID: 11463370BACKGROUND
  • Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. doi: 10.2147/copd.2006.1.1.3.

    PMID: 18046898BACKGROUND
  • Ozgundondu B, Gok Metin Z. Effects of progressive muscle relaxation combined with music on stress, fatigue, and coping styles among intensive care nurses. Intensive Crit Care Nurs. 2019 Oct;54:54-63. doi: 10.1016/j.iccn.2019.07.007. Epub 2019 Jul 29.

    PMID: 31371164BACKGROUND
  • Ranjita R, Hankey A, Nagendra HR, Mohanty S. Yoga-based pulmonary rehabilitation for the management of dyspnea in coal miners with chronic obstructive pulmonary disease: A randomized controlled trial. J Ayurveda Integr Med. 2016 Jul-Sep;7(3):158-166. doi: 10.1016/j.jaim.2015.12.001. Epub 2016 Aug 18.

    PMID: 27545747BACKGROUND
  • Basoglu OK, Atasever A, Bacakoglu F. The efficacy of incentive spirometry in patients with COPD. Respirology. 2005 Jun;10(3):349-53. doi: 10.1111/j.1440-1843.2005.00716.x.

    PMID: 15955148BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspneaCough

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sumera Hameed, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

June 17, 2024

Study Start

July 20, 2023

Primary Completion

December 1, 2023

Study Completion

December 10, 2023

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations