Clinical trial NCT06601764: Circuit and Resistance Training in COPD
Official title: Effects Of Circuit Training and Progressive Resistance Exercise Program On Pulmonary And Physical Parameters In COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Circuit Training
Resistance Exercise
Pulmonary Function
Physical Function
Progressive Resistance Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is characterized by a combination of pulmonary and extra-pulmonary manifestations that directly contribute to the increase in exercise intolerance and dyspnea, especially in more advanced stages of the disease, leading to physical inactivity and consequent worsening of these signs and symptoms. COPD is a preventable and treatable lung disease. Solid evidence shows that physical training, the most important component of a Pulmonary Rehabilitation program (PR), reduces dyspnea and fatigue, increases exercise performance, and improves peripheral muscle strength, functional capacity, control of emotional function and quality of life of these patients' lives. Multicomponent physical training (MPT) proposes the performance of 3 or more components or physical training modalities within the same session and has demonstrated its benefits in several studies involving the elderly population. The main objective of the study will be to determine the effects of circuit training and resistive exercises on pulmonary function and physical parameters in population with COPD.

The study will be a randomized clinical trial and conducted for a duration of 09 months after the approval of synopsis. Data will be collected with Non-Probability Convenience Sampling Technique. A sample of 48 COPD patients will be recruited from DHQ Muzaffargarh. This will be a double blinded study with patients and assessor blinded to the intervention. COPD patients will be divided into two groups with group 1 treated with circuit training and group 2 treated with resistance exercise for duration of 10 weeks. Baseline values for Respiratory parameters and physical parameters will be collected and after 5 weeks and 10 weeks of treatment. Data will be analyzed using SPSS v 26. For within the group analysis Repeated Measure ANOVA will be used. For across the group analysis, independent sample T test will be used to compare the mean differences.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a progressive disease with deteriorating cardiopulmonary function that decreases the health-related quality of life (HRQL) and exercise capacity. Patients with COPD often have cardiovascular and muscular problems that hinder oxygen uptake by peripheral tissues, resulting in poor oxygen consumption efficiency. Only 20% of the estimated COPD cases are currently being identified and diagnosed in primary care in Pakistan.

Circuit training should be considered the most effective strategy to improve exercise capacity in patients with COPD. Supervision of the programs improves exercise capacity. Concerning strength outcome, the Circuit Training increased the strength of the upper and lower extremities. Only the magnitude of strength performance appears to be influenced by the training (number of sessions and frequency) and the training status. Moreover, low and moderate intensities and short rest time between exercises increase the magnitude of change in fat mass loss. Therefore, CT has been shown to be an effective method for improving body composition, cardio-respiratory fitness, and strength of the lower and upper limbs. Moreover, CT has been shown to elicit higher oxygen consumption during the session in comparison to a traditional strength-training session. Modalities of resistance training using elastic components presented similar effects on muscle strength, health status, exercise capacity, body composition and daily level of physical activity in individuals with COPD. The effects of elastic resistance were similar to conventional resistance training. CT significantly improves aerobic performance (i.e., increase maximum aerobic speed and aerobic performance) and VO2max (average 6.3%), showing that this type of training increases cardio-respiratory fitness independent of the training protocol. CT had an overall significant and large effect on upper (bench press) and lower strength (leg extension) performance (1-RM).only the magnitude of strength performance appears to be influenced by the training (i.e., number of sessions and frequency) and population characteristics (i.e., training status).

Eligibility criteria: Inclusion Criteria:

* Age range from 40 to 70 years
* Clinical -functional diagnosis of COPD criteria GOLD II and III
* Clinically stable (outside the period of exacerbation of the disease for at least 3 months),
* Independently able to perform instrumental activities of daily living, as assessed by the functional activities questionnaire
* No medical contraindications for physical exercise.

Exclusion Criteria:

* Pulmonary diseases such as asthma, pulmonary fibrosis, pneumonia and other non-pulmonary
* Sever or difficult to control ( heart disease or sequelae of acute or chronic orthopedic and/or neurological diseases),
* Those who use walking assist devices that could influence the exercise
* Enrolled in a physical training program within the last 3 months at baseline

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: Baseline; 5th Week; 10th Week
measure: Pulmonary function test: Forced Vital Capacity (FVC)
timeFrame: Baseline; 5th Week; 10th Week
measure: Pulmonary function test: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Baseline; 5th Week; 10th Week
measure: Pulmonary function test: FEV1/FVC Ratio
timeFrame: Baseline; 5th Week; 10th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Zubair Khalid, MS*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: de Lima FF, Camillo CA, Grigoletto I, Uzeloto JS, Vanderlei FM, Ramos D, Ramos EMC. Effects of combining functional exercises with exercise training on daily physical activities and functionality in patients with COPD: a protocol for a randomized clinical trial. Trials. 2019 Dec 5;20(1):680. doi: 10.1186/s13063-019-3780-y.
citation: Rinaldo N, Bacchi E, Coratella G, Vitali F, Milanese C, Rossi A, Schena F, Lanza M. Effects of Combined Aerobic-Strength Training vs Fitness Education Program in COPD Patients. Int J Sports Med. 2017 Nov;38(13):1001-1008. doi: 10.1055/s-0043-112339. Epub 2017 Oct 5.