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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05876403
Other study ID # Maira Tamkeen
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 15, 2023

Study information

Verified date January 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date December 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional
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.
PNF
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.

Locations

Country Name City State
Pakistan Pakistan Railway General Hospital Islamabad AL

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Peak expiratory flow rate (PEFR) 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
Primary Forced vital capacity (FVC) 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
Primary Forced expiratory volume in 1sec (FEV1) 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
Primary Chest Expansion The expansion of chest during breathing will be measures and axillary, nipple and xiphisternal level using a measuring tape. two weeks
Primary Modified Borg Dyspnea Scale Participants will fill this 12 points Scale to show breathing difficulty from 0 to 10. two weeks
Primary COPD assessment test 8 points questionnaire will evaluate patients Pulmonary function capacity through semantic 6 point difference Scale. two weeks
Secondary 6 minutes walk test: This test with minimum important distance of 25 metres will assess aerobic & functional capacity of participants in a 6 minutes walk. two weeks
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