COPDCOPDNCT05876403
Respiratory Proprioceptive Neuromuscular Facilitation Technique in Chronic Pulmonary Obstructive Disease Patients.
A study testing Conventional and PNF in people with COPD, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- COPD
- What is being tested?
- Conventional and PNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Conventional, PNF
- Keywords
- Peak Expiratory Flow Rate (PEFR), Pulmonary function, PNF techniques
- 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.
ConventionalOther
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.
PNFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | 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. Receives: Other: Conventional |
| PNF Techniques | Experimental | 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 Receives: Other: PNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two weeks
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.
Measured: two weeks
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
Measured: two weeks
Chest Expansion
The expansion of chest during breathing will be measures and axillary, nipple and xiphisternal level using a measuring tape.
Measured: two weeks
Modified Borg Dyspnea Scale
Participants will fill this 12 points Scale to show breathing difficulty from 0 to 10.
Measured: two weeks
COPD assessment test
8 points questionnaire will evaluate patients Pulmonary function capacity through semantic 6 point difference Scale.
Measured: two weeks
Secondary outcomes (1)
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.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Sep 2023
- Primary completion15 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876403
- Sponsor's protocol ID
- Maira Tamkeen
- Acronym
- COPD
- Status last verified
- Jan 2024
- First submitted
- 17 May 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18503806Liu 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.
PubMed 33880021Reddy 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.
PubMed 30931074Make 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.
PubMed 30290931
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Proprioceptive Neuromuscular Facilitation (PNF) Technique on Pulmonary Function of Chronic Pulmonary Obstructive Disease (COPD) Patients.
- ClinicalTrials.gov ID
- NCT05876403
- Acronym / sponsor ID
- COPD / Maira Tamkeen
- Conditions
- COPD
- Keywords
- Peak Expiratory Flow Rate (PEFR), Pulmonary function, PNF techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: ConventionalThe 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. |
| PNF Techniques | Experimental | Other: PNFThe 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 |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConventionalThe 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. | Other | Conventional |
| PNFThe 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. | Other | PNF Techniques |
Primary outcome
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.
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.
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
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.
Modified Borg Dyspnea Scale
Time frame: two weeks
Participants will fill this 12 points Scale to show breathing difficulty from 0 to 10.
COPD assessment test
Time frame: two weeks
8 points questionnaire will evaluate patients Pulmonary function capacity through semantic 6 point difference Scale.
1 secondary outcome
6 minutes walk test:
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 18503806Putt 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.
- Background: PubMed 33880021Liu 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.
- Background: PubMed 30931074Reddy 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.
- Background: PubMed 30290931Make 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and PNF in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow rate (PEFR) (time frame: two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876403, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.