Chronic Obstructive Pulmonary DiseaseNCT04534062
Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients
A study testing PNF D2 technique in people with Chronic Obstructive Pulmonary Disease, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of morbidity and disability with 251 million cases per anum reported worldwide. COPD ranks fourth among the common causes of mortality with an estimated 3 million annual deaths worldwide that is projected to be third by 2020. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PNF D2 technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 22 Feb 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed COPD patients of Age 40 and above (Razzaq et al., 2018)
- COPD grade 2 and 3 according to GOLD classification (Berry et al., 2018) (Goldcopd.org, 2019)
- COPD patient both male and female
Who cannot join
- Individuals with either fractures of ribs or upper limb
- Pulmonary Effusion,
- Pulmonary Edema,
- Embolism,
- Pneumothorax
- Hemothorax
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of morbidity and disability with 251 million cases per anum reported worldwide. COPD ranks fourth among the common causes of mortality with an estimated 3 million annual deaths worldwide that is projected to be third by 2020. COPD deaths are more prevalent among the low socio-economic developing countries, estimated up to 90% of the total mortality rate across the globe. In Asia, 13.5% of the total population suffers with COPD. Particularly, in Pakistan every 10th individual suffers with COPD out of which 19.4% are of age above 40 years. Moreover, the problem has been identified as a growing public health concern and a challenge for the clinicians of 21st century. Consequently, the severity of the condition of patients is contributed by exacerbations or co-morbidities, and significant economic burden due to the hospitalizations, absence from work and disability; and its management cost from $1544 to $2335 in Asian countries, annually. However, specific data economic burden for Pakistan is not reported yet. A number of pharmaceutical and non-pharmaceutical treatment options are utilized in the management of COPD; however, pulmonary rehabilitation has been conferred as the corner stone in management of COPD. NICE guidelines emphasize upon the importance of pulmonary rehabilitation for all individuals presenting with COPD; even those who have acutely suffered an exacerbation or underwent recent hospitalization. Moreover, pulmonary rehabilitation consisting of structured exercises regimes and education regarding self-care has been reported to improve COPD symptoms and exercise tolerance; and reduce expenditure of resources on recurrent hospitalization and length of stay. Study has reported that resistance training demonstrated in better improvement in muscular strength than endurance exercise and causes lesser chances of dyspnea while performing activities and is more tolerable than endurance exercise regime. Literature is evident upon that the combination of resistance and endurance training has shown significant improvement in the respiratory parameters. Hence the present study is aimed to incorporate Proprioceptive Neuromuscular Facilitation (PNF) D2 pattern including different types of resistance training in order to determine the response of adjunct therapies on the outcome measures.
Read the detailed description
Data Collection Procedure:
The participants will be divided into three groups A, B and C on the basis of randomization performed using an envelope technique. The participants in group A will perform PNF D2 with free weights (PNF D2 FW), participants of Group B will perform PNF D2 with elastic bands (PNF D2 ERB) while Group C will be control group and the participants of this group will perform PNF D2 without resistance (PNF D2 WR). Initially, consent will be obtained from all participants after explaining them the protocols of treatment. The Pulmonary Function Test (PFT) will be performed to record pre-intervention spirometric values of FEV1/FVC (Tiffeneau-Pinelli Index), Minute Ventilation (MV), Force expiratory volume in 1 second (FEV1), Forced Vital capacity (FVC), Total Lung Capacity (TLC) and Residual Volume (RV). Similarly, 6 Minute Walk Test (6MWT) and St. George's Respiratory Questionnaire Score will be recorded to determine the exercise capacity and health status score of COPD patient respectively. Following the assessment procedure, both groups will receive 8 weeks of treatment with frequency of 3 sessions per week lasting for 30 minutes approximately.
Intervention Protocol Group A Participants in Group A will perform PNF D2 flexion and extension with free weights (PNF D2 FW) The intensity of exercise will be determined for each individual by using maximum repetition test (1 repetition maximum 1-RM). The intensity will be kept 50 % of the maximal load. 3 sets of PNF D2 FW Flexion (flexion-abduction and external rotation) and PNF D2 FW Extension (extension-adduction-internal rotation) respectively will be performed on each upper limb with 10 repetitions per set. All exercises will be performed with a rest interval of 30 seconds to 1 minute between the sets.
Intervention Protocol Group B Participants in this group will perform 3 sets of PNF D2 flexion (flexion-abduction and external rotation) and extension (extension-adduction-internal rotation) respectively with elastic bands after assessing the 1-RM test starting with a lightest resistance and gradually progressing to the higher level. Subsequently, 71% to 86% of 1-RM will be taken as a target range of the resistance for the training . Moreover, each set will consist of 10 repetitions for both D2 flexion and Extension and a resting interval of 60 seconds between two consecutive sets. The procedure will be repeated for both limbs.
Intervention Protocol Group C The participants in the Group C or control group will perform the PNF D2 flexion and extension without any resistance. Three sets consist of 10 repetitions of each pattern for both upper limbs will be performed with an interval of 60 seconds between two consecutive sets.
After 8 weeks of training, the pulmonary function test (PFT), 6 Minute Walk Test and George's Respiratory Questionnaire scores will be recorded for post intervention readings. Results will be recorded and statistical analysis will be performed.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PNF D2 technique
- 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.
PNF D2 techniqueOther
PNF D2 technique of bilateral upper limb will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in Group A will perform PNF D2 flexion and extension with free weights (PNF D2 FW) The intensity of exercise will be determined for each individual by using maximum repetition test (1 repetition maximum 1-RM). The intensity will be kept 50 % of the maximal load. 3 sets of PNF D2 FW Flexion (flexion-abduction and external rotation) and PNF D2 FW Extension (extension-adduction-internal rotation) respectively will be performed on each upper limb with 10 repetitions per set. All exercises will be performed with a rest interval of 30 seconds to 1 minute between the sets. Receives: Other: PNF D2 technique |
| Group B | Experimental | Participants in this group will perform 3 sets of PNF D2 flexion (flexion-abduction and external rotation) and extension (extension-adduction-internal rotation) respectively with elastic bands after assessing the 1-RM test starting with a lightest resistance and gradually progressing to the higher level. Subsequently, 71% to 86% of 1-RM will be taken as a target range of the resistance for the training that will be applied through Elastic Resistance Band in accordance with values that are provided on the Thera-Band website. Moreover, each set will consist of 10 repetitions for both D2 flexion and Extension and a resting interval of 60 seconds between two consecutive sets. The procedure will be repeated for both limbs. Receives: Other: PNF D2 technique |
| Group C | Experimental | The participants in the Group C or control group will perform the PNF D2 flexion and extension without any resistance. Three sets consist of 10 repetitions of each pattern for both upper limbs will be performed with an interval of 60 seconds between two consecutive sets. Receives: Other: PNF D2 technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC Ratio(Pre-intervention)
Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio
Measured: Baseline
FEV1/FVC Ratio(Pre-intervention)
Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio
Measured: On the completion of 8 weeks of intervention
FVC (Forced Vital Capacity) (Pre-intervetion)
Spirometry is used to assessed Forced Vital Capacity
Measured: Baseline
FVC (Forced Vital Capacity) (Pre-intervetion)
Spirometry is used to assessed Forced Vital Capacity
Measured: On the completion of 8 weeks of intervention
Exercise Capacity
6 minute walk test is used to assessed the exercise capacity
Measured: Baseline
Exercise Capacity
6 minute walk test is used to assessed the exercise capacity
Measured: On the completion of 8 weeks of intervention
Health Status
St. George Respiratory Questionnaire is used to assessed the health status
Measured: Baseline
Health Status
6 minute walk test is used to assessed the exercise capacity
Measured: On the completion of 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Oct 2020
- Primary completion22 Dec 2020 (estimated)
- Study completion22 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ather Hashmi, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534062
- Sponsor's protocol ID
- MAther
- Status last verified
- Nov 2020
- First submitted
- 17 Aug 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients
- ClinicalTrials.gov ID
- NCT04534062
- Acronym / sponsor ID
- MAther
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 Dec 2020 (estimated)
- Study completion
- 22 Feb 2021 (estimated)
- First posted
- 1 Sep 2020 (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.
Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of morbidity and disability with 251 million cases per anum reported worldwide. COPD ranks fourth among the common causes of mortality with an estimated 3 million annual deaths worldwide that is projected to be third by 2020. COPD deaths are more prevalent among the low socio-economic developing countries, estimated up to 90% of the total mortality rate across the globe. In Asia, 13.5% of the total population suffers with COPD. Particularly, in Pakistan every 10th individual suffers with COPD out of which 19.4% are of age above 40 years. Moreover, the problem has been identified as a growing public health concern and a challenge for the clinicians of 21st century. Consequently, the severity of the condition of patients is contributed by exacerbations or co-morbidities, and significant economic burden due to the hospitalizations, absence from work and disability; and its management cost from $1544 to $2335 in Asian countries, annually. However, specific data economic burden for Pakistan is not reported yet. A number of pharmaceutical and non-pharmaceutical treatment options are utilized in the management of COPD; however, pulmonary rehabilitation has been conferred as the corner stone in management of COPD. NICE guidelines emphasize upon the importance of pulmonary rehabilitation for all individuals presenting with COPD; even those who have acutely suffered an exacerbation or underwent recent hospitalization. Moreover, pulmonary rehabilitation consisting of structured exercises regimes and education regarding self-care has been reported to improve COPD symptoms and exercise tolerance; and reduce expenditure of resources on recurrent hospitalization and length of stay. Study has reported that resistance training demonstrated in better improvement in muscular strength than endurance exercise and causes lesser chances of dyspnea while performing activities and is more tolerable than endurance exercise regime. Literature is evident upon that the combination of resistance and endurance training has shown significant improvement in the respiratory parameters. Hence the present study is aimed to incorporate Proprioceptive Neuromuscular Facilitation (PNF) D2 pattern including different types of resistance training in order to determine the response of adjunct therapies on the outcome measures.
Detailed description
Data Collection Procedure:
The participants will be divided into three groups A, B and C on the basis of randomization performed using an envelope technique. The participants in group A will perform PNF D2 with free weights (PNF D2 FW), participants of Group B will perform PNF D2 with elastic bands (PNF D2 ERB) while Group C will be control group and the participants of this group will perform PNF D2 without resistance (PNF D2 WR). Initially, consent will be obtained from all participants after explaining them the protocols of treatment. The Pulmonary Function Test (PFT) will be performed to record pre-intervention spirometric values of FEV1/FVC (Tiffeneau-Pinelli Index), Minute Ventilation (MV), Force expiratory volume in 1 second (FEV1), Forced Vital capacity (FVC), Total Lung Capacity (TLC) and Residual Volume (RV). Similarly, 6 Minute Walk Test (6MWT) and St. George's Respiratory Questionnaire Score will be recorded to determine the exercise capacity and health status score of COPD patient respectively. Following the assessment procedure, both groups will receive 8 weeks of treatment with frequency of 3 sessions per week lasting for 30 minutes approximately.
Intervention Protocol Group A Participants in Group A will perform PNF D2 flexion and extension with free weights (PNF D2 FW) The intensity of exercise will be determined for each individual by using maximum repetition test (1 repetition maximum 1-RM). The intensity will be kept 50 % of the maximal load. 3 sets of PNF D2 FW Flexion (flexion-abduction and external rotation) and PNF D2 FW Extension (extension-adduction-internal rotation) respectively will be performed on each upper limb with 10 repetitions per set. All exercises will be performed with a rest interval of 30 seconds to 1 minute between the sets.
Intervention Protocol Group B Participants in this group will perform 3 sets of PNF D2 flexion (flexion-abduction and external rotation) and extension (extension-adduction-internal rotation) respectively with elastic bands after assessing the 1-RM test starting with a lightest resistance and gradually progressing to the higher level. Subsequently, 71% to 86% of 1-RM will be taken as a target range of the resistance for the training . Moreover, each set will consist of 10 repetitions for both D2 flexion and Extension and a resting interval of 60 seconds between two consecutive sets. The procedure will be repeated for both limbs.
Intervention Protocol Group C The participants in the Group C or control group will perform the PNF D2 flexion and extension without any resistance. Three sets consist of 10 repetitions of each pattern for both upper limbs will be performed with an interval of 60 seconds between two consecutive sets.
After 8 weeks of training, the pulmonary function test (PFT), 6 Minute Walk Test and George's Respiratory Questionnaire scores will be recorded for post intervention readings. Results will be recorded and statistical analysis will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: PNF D2 techniqueParticipants in Group A will perform PNF D2 flexion and extension with free weights (PNF D2 FW) The intensity of exercise will be determined for each individual by using maximum repetition test (1 repetition maximum 1-RM). The intensity will be kept 50 % of the maximal load. 3 sets of PNF D2 FW Flexion (flexion-abduction and external rotation) and PNF D2 FW Extension (extension-adduction-internal rotation) respectively will be performed on each upper limb with 10 repetitions per set. All exercises will be performed with a rest interval of 30 seconds to 1 minute between the sets. |
| Group B | Experimental | Other: PNF D2 techniqueParticipants in this group will perform 3 sets of PNF D2 flexion (flexion-abduction and external rotation) and extension (extension-adduction-internal rotation) respectively with elastic bands after assessing the 1-RM test starting with a lightest resistance and gradually progressing to the higher level. Subsequently, 71% to 86% of 1-RM will be taken as a target range of the resistance for the training that will be applied through Elastic Resistance Band in accordance with values that are provided on the Thera-Band website. Moreover, each set will consist of 10 repetitions for both D2 flexion and Extension and a resting interval of 60 seconds between two consecutive sets. The procedure will be repeated for both limbs. |
| Group C | Experimental | Other: PNF D2 techniqueThe participants in the Group C or control group will perform the PNF D2 flexion and extension without any resistance. Three sets consist of 10 repetitions of each pattern for both upper limbs will be performed with an interval of 60 seconds between two consecutive sets. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed COPD patients of Age 40 and above (Razzaq et al., 2018)
- COPD grade 2 and 3 according to GOLD classification (Berry et al., 2018) (Goldcopd.org, 2019)
- COPD patient both male and female
Key exclusion criteria (6 listed)
- Individuals with either fractures of ribs or upper limb
- Pulmonary Effusion,
- Pulmonary Edema,
- Embolism,
- Pneumothorax
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 |
|---|---|---|
| PNF D2 techniquePNF D2 technique of bilateral upper limb will be performed | Other | Group A, Group B, Group C |
Primary outcome
FEV1/FVC Ratio(Pre-intervention)
Time frame: Baseline
Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio
FEV1/FVC Ratio(Pre-intervention)
Time frame: On the completion of 8 weeks of intervention
Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio
FVC (Forced Vital Capacity) (Pre-intervetion)
Time frame: Baseline
Spirometry is used to assessed Forced Vital Capacity
FVC (Forced Vital Capacity) (Pre-intervetion)
Time frame: On the completion of 8 weeks of intervention
Spirometry is used to assessed Forced Vital Capacity
Exercise Capacity
Time frame: Baseline
6 minute walk test is used to assessed the exercise capacity
Exercise Capacity
Time frame: On the completion of 8 weeks of intervention
6 minute walk test is used to assessed the exercise capacity
Health Status
Time frame: Baseline
St. George Respiratory Questionnaire is used to assessed the health status
Health Status
Time frame: On the completion of 8 weeks of intervention
6 minute walk test is used to assessed the exercise capacity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF D2 technique in people with Chronic Obstructive Pulmonary Disease, run by Ziauddin 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 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. 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?
Results are not available in the source record.
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?
FEV1/FVC Ratio(Pre-intervention) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2020.