Resistive Expiratory Muscle Training in COPD Patients

Effects of Resistive Expiratory Muscle Training on Pulmonary Functions in Patients With COPD Patients

• To determine effects of resistive expiratory muscle training on pulmonary functions in Chronic obstructive pulmonary disease (COPD) patients
• To determine effects of resistive expiratory muscle training on maximum expiratory pressure in COPD patients
• To determine effects of resistive expiratory muscle training on quality of life in COPD patients

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Resistive Expiratory muscle Training Group; Other: Conventional Breathing Exercise Group

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Holy Family Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patients (GOLD criteria - moderate, moderately severe)
• Borg scale < 4

Exclusion Criteria:

• Patients with Orthopedic disease
• Neurological disease,
• Cognitive impairment (Mini-Mental State Examination < 22) ,
• Heart diseases,
• Pulmonary fibrosis
• Obstructive sleep apnea syndrome.
• Acute and chronic infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Resistive Expiratory muscle Training Group; Mild Resistive Expiratory muscle Training Group	Other: Resistive Expiratory muscle Training Group; Mild Resistive Expiratory Technique [Expiratory Muscle Strength Training (EMST150)- six-week training protocol approximately 20 min per day] The EMST requires the participant to forcibly blow into the device for 5 seconds with sufficient pressure to open the one-way valve. Each "blow" is one repetition. The device will be set at a resistance of 30 cmH2O. Participants will be instructed to complete five sets of five repetitions (total of 25 times and approximately 20 minutes per day), any five days per week, for six weeks. Whole exercise will be done in sitting position. Rest between repetitions will be given according to comfort level of patient.
ACTIVE_COMPARATOR: Conventional Breathing Exercise Group; Breathing Ex: Pursed lip Breathing, Diaphragmatic breathing ex, incentive spirometer	Other: Conventional Breathing Exercise Group; Breathing Exercises: (approximately 20 minutes per day) ● Pursed lip breathing: (Sit with your back straight. Inhale through your nose for two seconds. Purse your lips like you're blowing on hot food and then breathe out slowly, taking twice as long to exhale as you took to breathe in. 4-5 times a day) ● Diaphragmatic breathing: (Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs. Breathe in slowly through your nose Tighten your stomach muscles, letting them fall inward as you exhale through pursed lips. Practice this exercise 5-10 minutes about 3-4 times per day). ● Incentive spirometer: (Hold in an upright position. Breathe in slowly and as deeply as possible. Hold your breath as long as possible (at least for 5 seconds). Then exhale slowly Rest for a few seconds and at least 10 times every hour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1 second (FEV1)	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters	6 Week
Peak Expiratory Flow (PEF)	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.	6 Week
Maximum expiratory pressure	Maximum expiratory pressure (MEP) measures the maximum positive pressure that can be generated from one expiratory effort starting from total lung capacity (TLC) . Changes will be assessed from the baseline and at the end of the intervention after 6 weeks	6 weeks
St George's Respiratory Questionnaire	This is a specific respiratory instrument developed for patients with COPD. Its validity, reproducibility and response to change over time have been demonstrated. It has three components: symptoms, activity and impact. The responses to the items can be aggregated into an overall score and three sub-scores for symptoms, activity and impact in the range 0-100%. Higher scores indicate a poorer quality of life).Changes will be assessed from the baseline and at the end of the intervention after 6 weeks	6 Week
Forced vital Capacity (FVC)	Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.	6 week
Volume of Lungs inflation	The incentive spirometer is a device that encourages patients with visual and other positive feedback, to maximally inflate their lungs and sustain that inflation. It is a common mode of postoperative respiratory therapy and involves deep breathing facilitated by a simple mechanical device. Maximal volume of lung inflation is thought to open collapsed alveoli and thereby prevent and resolve atelectasis. When all three balls reached their column tops, it indicated that the subject was able to generate inspiratory airflow of 1200 ml/ml. When only two balls reached their column tops, it indicated that the subject generated 900 ml/min. When only one ball reached their column tops, it indicated that the subject could only generate 600 ml/min. Changes will be assessed from the baseline and at the end of the intervention after 6 weeks	6 week

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2021
• Primary Completion (ACTUAL): January 15, 2022
• Study Completion (ACTUAL): January 15, 2022

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (ACTUAL): September 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Quality of Life; Pulmonary Function; Breathing Exercise; Resistive Expiratory Muscle training
• Other Study ID Numbers: REC/01082 Varda Farooq

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No