- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876403
Respiratory Proprioceptive Neuromuscular Facilitation Technique in Chronic Pulmonary Obstructive Disease Patients. (COPD)
Effects of Respiratory Proprioceptive Neuromuscular Facilitation (PNF) Technique on Pulmonary Function of Chronic Pulmonary Obstructive Disease (COPD) Patients.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
AL
-
Islamabad, AL, Pakistan, 44000
- Pakistan Railway General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Suman Sheraz, PhD*, Riphah International University
Publications and helpful links
General Publications
- Putt MT, Watson M, Seale H, Paratz JD. Muscle stretching technique increases vital capacity and range of motion in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008 Jun;89(6):1103-7. doi: 10.1016/j.apmr.2007.11.033.
- Liu K, Yu X, Cui X, Su Y, Sun L, Yang J, Han W. Effects of Proprioceptive Neuromuscular Facilitation Stretching Combined with Aerobic Training on Pulmonary Function in COPD Patients: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2021 Apr 13;16:969-977. doi: 10.2147/COPD.S300569. eCollection 2021.
- Reddy RS, Alahmari KA, Silvian PS, Ahmad IA, Kakarparthi VN, Rengaramanujam K. Reliability of Chest Wall Mobility and Its Correlation with Lung Functions in Healthy Nonsmokers, Healthy Smokers, and Patients with COPD. Can Respir J. 2019 Feb 25;2019:5175949. doi: 10.1155/2019/5175949. eCollection 2019.
- Make BJ, Yawn BP. Breathing Life Into COPD Management: Ongoing Monitoring, Pulmonary Rehabilitation, and Individualized Care. Chest. 2018 Oct;154(4):980-981. doi: 10.1016/j.chest.2018.08.1023.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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