Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients

NCT04534062 | Unknown

• 1 other identifier: MAther
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (8)

• FEV1/FVC Ratio(Pre-intervention)

  Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio

  Baseline

• FEV1/FVC Ratio(Pre-intervention)

  Spirometry is used to assessed the FEV1/FVC (Forced Expiratory Volume in 1st second/ Forced Vital Capacity) Ratio

  On the completion of 8 weeks of intervention

• FVC (Forced Vital Capacity) (Pre-intervetion)

  Spirometry is used to assessed Forced Vital Capacity

  Baseline

• FVC (Forced Vital Capacity) (Pre-intervetion)

  Spirometry is used to assessed Forced Vital Capacity

  On the completion of 8 weeks of intervention

• Exercise Capacity

  6 minute walk test is used to assessed the exercise capacity

  Baseline

• Exercise Capacity

  6 minute walk test is used to assessed the exercise capacity

  On the completion of 8 weeks of intervention

• Health Status

  St. George Respiratory Questionnaire is used to assessed the health status

  Baseline

• Health Status

  6 minute walk test is used to assessed the exercise capacity

  On the completion of 8 weeks of intervention

Study Arms (3)

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.

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.

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.

Other: PNF D2 technique

Interventions

PNF D2 technique OTHER

PNF D2 technique of bilateral upper limb will be performed

Group A; Group B; Group C

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals with either fractures of ribs or upper limb
• Pulmonary Effusion,
• Pulmonary Edema,
• Embolism,
• Pneumothorax
• Hemothorax

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participant will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 1, 2020
• Study Start: October 1, 2020
• Primary Completion: December 22, 2020
• Study Completion: February 22, 2021
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)