Resistive Expiratory Muscle Training in COPD Patients

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 40 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

COPD

Being tested

Resistive Expiratory muscle Training Group, Conventional Breathing Exercise Group

Keywords

Resistive Expiratory Muscle training, Breathing Exercise, Pulmonary Function, Quality of Life

Medical subject headings

Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Resistive Expiratory muscle Training GroupOther

  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.

• Conventional Breathing Exercise GroupOther

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: 6 weeks

2. 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

   Measured: 6 Week

3. 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

   Measured: 6 Week

4. Forced vital Capacity (FVC)

   Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.

   Measured: 6 week

5. 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.

   Measured: 6 Week

6. 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

   Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Sep 2021
2. Study start10 Oct 2021
3. Primary completion15 Jan 2022
4. Study completion15 Jan 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for COPDStudies of the same condition, open and under way.
• More trials run by Riphah International UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.