Clinical trial NCT04534062: Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients
Official title: Effects of PNF D2 Technique With Resistance on Pulmonary Function, Exercise Capacity and Health Status of COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: FEV1/FVC Ratio(Pre-intervention)
timeFrame: Baseline
measure: FEV1/FVC Ratio(Pre-intervention)
timeFrame: On the completion of 8 weeks of intervention
measure: FVC (Forced Vital Capacity) (Pre-intervetion)
timeFrame: Baseline
measure: FVC (Forced Vital Capacity) (Pre-intervetion)
timeFrame: On the completion of 8 weeks of intervention
measure: Exercise Capacity
timeFrame: Baseline
measure: Exercise Capacity
timeFrame: On the completion of 8 weeks of intervention
measure: Health Status
timeFrame: Baseline
measure: Health Status
timeFrame: On the completion of 8 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University
state: Sindh
Study officials:
References: