Respiratory Proprioceptive Neuromuscular Facilitation Technique in Chronic Pulmonary Obstructive Disease Patients. (COPD)

January 28, 2024 updated by: Riphah International University

Effects of Respiratory Proprioceptive Neuromuscular Facilitation (PNF) Technique on Pulmonary Function of Chronic Pulmonary Obstructive Disease (COPD) Patients.

The purpose of this study is to evaluate the impact of PNF technique combined with aerobic exercises among COPD patients in a clinical setting. Previous literature has evaluated this technique in ventilated patients but in clinical setting specifically in Pakistan, this invention therapy has not been implied in COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Obstructive Pulmonary Disorder manifested as breathlessness, respiratory difficulties and persistent cough is one of the biggest causes of mortality around the world. 2.1% of Pakistani population has COPD. Proprioceptive neuromuscular facilitation is used as management technique in which muscle stretching promotes chest wall mobility and restores regular breathing rhythm. In previous studies, PNF technique combined with aerobic exercises has been utilized to improve Pulmonary functions in COPD patients. But the sample size of these studies was small and participants were ventilated patients, hence not targeting the diaphragm. Our study shall evaluate the impact of PNF technique combined with aerobic training on the Pulmonary function of COPD patients in the clinical setting.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • AL
      • Islamabad, AL, Pakistan, 44000
        • Pakistan Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both male & female participants.
  • Diagnosed COPD patients
  • Age 35-60years
  • Ratio of forced expiratory volume in first second & forced vital capacity(FEV1/FVC <0.7,30%<FEV1<80%
  • Stable clinical condition.

Exclusion Criteria:

  • Serious conditions with require supplementary oxygen or ventilator/support devices.
  • COPD exacerbation within last 4weeks
  • Patients with recent chest wall trauma, surgery or deformity.
  • Patient with neurological, psychological, musculoskeletal, or cardiac medical history.
  • Pulmonary disease with physical impairment.
  • Inability to follow the pulmonary rehabilitation program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional

The protocol for controlled group will consist of 35-60years old participants with moderate to severe COPD.

At baseline measurements will be collected and COPD assessment test (CAT) and Modified Borg Scale will be taken. Participants will then be made to perform breathing and aerobic exercises (3sessions per week) for 6 weeks and after every 2 weeks outcome measures will be evaluated using chest expansion, spirometry, and 6 minutes walk test (6MWT) along with CAT and Modified Borg Scale.

The participants of controlled group will be given the treatment protocol after baseline measurements controlled breathing techniques (3session per week 10mins for 6 weeks) & Aerobic exercise(3 session per week for 6 weeks) with 10sec hold into 10reps.outcome measures will be recorded through a digital spirometer & measurement of 6MWT & chest expansion.
Experimental: PNF Techniques
The same protocol will be followed for the 30 participants of experimental group where after the baseline measurements, participants will perform breathing and aerobic exercises along with PNF techniques (3 sessions per week for 6 weeks). The outcome Measures will be measured after every 2 weeks through Spirometry, CAT, Modified Borg Dyspnea Scale and 6 minutes walk test
The participants of experimental group will be given the Intervention protocol after baseline measurements. Additionally these 30 participants will also receive PNF technique exercises consisting of Thoracic Vertebral pressure, Anterior Basal stretch, and Intercostal stretch for 20-25 minutes in 3 sessions per week, and outcomes Measures will be recorded through a digital spirometer and measurements of 6 minutes walk test and chest Expansion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak expiratory flow rate (PEFR)
Time Frame: two weeks
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
two weeks
Forced vital capacity (FVC)
Time Frame: two weeks

Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.

Changes in FVC from baseline to 5th and after 15th day of intervention will be assessed.

two weeks
Forced expiratory volume in 1sec (FEV1)
Time Frame: two weeks
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal
two weeks
Chest Expansion
Time Frame: two weeks
The expansion of chest during breathing will be measures and axillary, nipple and xiphisternal level using a measuring tape.
two weeks
Modified Borg Dyspnea Scale
Time Frame: two weeks
Participants will fill this 12 points Scale to show breathing difficulty from 0 to 10.
two weeks
COPD assessment test
Time Frame: two weeks
8 points questionnaire will evaluate patients Pulmonary function capacity through semantic 6 point difference Scale.
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walk test:
Time Frame: two weeks
This test with minimum important distance of 25 metres will assess aerobic & functional capacity of participants in a 6 minutes walk.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Suman Sheraz, PhD*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Maira Tamkeen

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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