Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05947227

Collaborator

(none)

Enrollment

Location

Arms

6.2

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Breathing Technique	Other: Buteyko breathing technique Other: Diaphragmatic breathing technique.	N/A

Detailed Description

A randomized clinical trial will be conducted at Gulab Devi Hospital, Lahore through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed enveloped into group A and group B. Pre-treatment values of patients exercise capacity will be recorded by 6MWT/6MWD- 6 minute walk test/ 6 minutes' walk distance and patients quality of life through St George respiratory questionnaire as primary outcomes while oxygen saturation, heart rate will be measured by pulse oximtery during 6MWT as secondary outcomes. Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks.

Data will be analyzed using SPSS software version 25.After assessing normality of data by Shapiro-Wilk test , it will be decidedeither parametric or non-parametric test will be used.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks.Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD

Actual Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Nov 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: manual chest physical therapy and Buteyko breathing technique Group A will be treated with manual chest physical therapy and Buteyko breathing technique	Other: Buteyko breathing technique Group A : will be treated with manual chest physiotherapy & Buteyko Breathing exercise
Experimental: manual chest physical therapy and Diaphragmatic breathing technique. Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.	Other: Diaphragmatic breathing technique. Group B : will be treated with manual chest physiotherapy & Diaphragmatic Breathing Treatment evaluation will be done after 8 weeks through 6MWT & St George respiratory Questionnaire. Patients will perform technique 5 times a weeks for 8 weeks

Arm

Intervention/Treatment

Experimental: manual chest physical therapy and Buteyko breathing technique

Group A will be treated with manual chest physical therapy and Buteyko breathing technique

Other: Buteyko breathing technique

Group A : will be treated with manual chest physiotherapy & Buteyko Breathing exercise

Experimental: manual chest physical therapy and Diaphragmatic breathing technique.

Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.

Other: Diaphragmatic breathing technique.

Group B : will be treated with manual chest physiotherapy & Diaphragmatic Breathing Treatment evaluation will be done after 8 weeks through 6MWT & St George respiratory Questionnaire. Patients will perform technique 5 times a weeks for 8 weeks

Outcome Measures

Primary Outcome Measures

6 Minute Walk Distance [4 weeks.]
Distance will be measured in meter through 6 minute walk test.

Secondary Outcome Measures

St George Respiratory Questionnaire for quality of life : [4 weeks.]
St George Respiratory Questionnaire/SGRQ is a well established disease specific for health status in asthma and COPD (26).A total three component scores are provided , symptoms (8 items) , activity (16 items) and impacts (26 items), 50 items vary as likert type scale and dichotomus (true/false). In the symptom component , patients are instructed to recall their symptoms in a specific time frame of 1 month , 3 months or 1 year. Other items are not time specific.Scores ranged from 0 ( no impairment ) to 100 ( worst health status)

Other Outcome Measures

oxygen saturation [4 weeks]
Oxygen saturation will be measured through pulse oximeter.
heart rate [4 weeks]
Pulse rate will be measured through pulse oximeter which will be consider as heart rate of the patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age group : 40-65 years
Both males and females
Clinical diagnosis of COPD confirmed by smoking history and PFT airflow
Patients taking their regular medications e.g bronchodilator

Exclusion Criteria:

Restrictive lung disease
Pneumothorax
Resting O2 saturation <90% with room air breathing
Recent exacerbations
Patients with active viral or bacterial infection
Abdominal or thoracic surgery (<3months ago)
Cardiologic conditions (<6months ago e.g Myocardial infarction or unstable angina
Intubated Patients
Orthopedic or urogenital conditions
Neurological disorders limiting cognition & mobility

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulab Devi Hospital, Lahore	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Sidra Faisal, MS.CPPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05947227

Other Study ID Numbers:

REC/RCR & AHS/23/0311

First Posted:

Jul 17, 2023

Last Update Posted:

Jul 17, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Chronic obstructive pulmonary disease/COPD

Diaphragmatic breathing technique

Additional relevant MeSH terms:

Respiratory Aspiration

Study Results

No Results Posted as of Jul 17, 2023