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Clinical Trials/CTRI/2025/08/092136
CTRI/2025/08/092136
Not yet recruiting
Not Applicable

Effect of Structured Breathing Exercise Protocol along with Proprioceptive Neuromuscular Facilitation Stretching on functional capacity, Peak expiratory flow rate and HR-QoL in COPD patients.

Not provided1 site in 1 country62 target enrollmentStarted: August 11, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
62
Locations
1
Primary Endpoint
CAT COPD Assessment of QoL Questionnaire

Overview

Brief Summary

All the participants referred from the IPD medicine department for physiotherapy will be screened based on the inclusion and exclusion criteria. Participants will be briefed about the nature of the study and the effect of the intervention in the language best understood by them and the treatment will be demonstrated to them. Written informed consent will be obtained and they will be divided into 2 groups groups A and B, by using numbered sealed opaque envelopes.

Group A The control group will receive the Structured Breathing Exercise Protocol.

Group B The experimental group will receive Structured Breathing Exercise Protocol along with PNF Stretching for accessory respiratory muscles.

All the participants will be assessed for functional capacity using the 6 min walk test, for peak expiratory flow rate (PEFR) using the peak flow meter and for Quality of Life (QoL) with the CAT COPD Assessment Questionnaire. The measurements will be done on the 1st and the last day of the 2-week intervention program to give values pre and post training for each participant. The intervention duration for Group A will be one session a day for 30 minutes for 2 weeks (6 days a week) and Group B will be one session a day for 45 minutes for 2 weeks (6 days a week).

Comparison between both the findings will be done and the conclusion will be made.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Participants included will be
  • Participants with moderate to severe COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease GOLD GOLD 2 Moderate using a peak flow meter with 150 to 249 l/min PEFR.
  • GOLD 3 Severe using a peak flow meter with 100 to 149 l/min PEFR.
  • 30 to 60 years old patients with COPD.
  • Both males and females.
  • Ability to provide written informed consent and willingness to participate in the full duration of the study.

Exclusion Criteria

  • Participants excluded will be 1) Serious conditions that require ventilatory support 2) Any neurological condition where the patient is unable to follow the therapists commands 3) Cognitive disorders with a definite medical history 4) With Severe complications like Cor Pulmonale Atelectasis etc.
  • Patients who had recently undergone major surgeries like abdominal cardio-thoracic or gynecological surgery 6) Patients with musculoskeletal disorders like clavicle scapula humerus sternum or ribs fracture flail chest or shoulder dislocation 7) Open wounds at or near chest.

Outcomes

Primary Outcomes

CAT COPD Assessment of QoL Questionnaire

Time Frame: At baseline and after 2 weeks

PEFR

Time Frame: At baseline and after 2 weeks

6 min walk test

Time Frame: At baseline and after 2 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Dhruvi Satra

Dr. APJ Abdul Kalam COPT, Pravara Institute of Medical Sciences, Loni, Maharashtra, India

Study Sites (1)

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