NCT06601764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

September 16, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

Circuit TrainingResistance ExercisePulmonary FunctionPhysical FunctionProgressive Resistance Training

Outcome Measures

Primary Outcomes (4)

  • 6 Minute Walk Test

    6MWT is a sub-maximal exercise test used to examine person aerobic capacity and endurance. This test initially developed to make an assessment of patient with cardiopulmonary issues. It is used to check the functional capacity of the individual and it provides useful information regarding all the body systems during physical activity, including cardiovascular and pulmonary system. It can used for all age group range 2 to above 64 years The test is easy to perfume , with standardized limited instructions and encouragement being given as person walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters.(

    Baseline; 5th Week; 10th Week

  • Pulmonary function test: Forced Vital Capacity (FVC)

    The FVC is the forced vital capacity. It requires that the subject make a maximal inspiration to TLC, then make a maximal forced expiratory effort, leaving only the RV. In a normal subject, the FEV1/FVC is greater than 0.8; patients with obstructive lung disease, such as asthma or COPD, show a decreased FEV1/FVC

    Baseline; 5th Week; 10th Week

  • Pulmonary function test: Forced Expiratory Volume in 1 second (FEV1)

    Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. FEV1 values that are lower than average suggest the presence of COPD.

    Baseline; 5th Week; 10th Week

  • Pulmonary function test: FEV1/FVC Ratio

    The FEV1/FVC ratio is a measurement of lung function that compares the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). It\'s used to help diagnose and monitor lung conditions.

    Baseline; 5th Week; 10th Week

Study Arms (2)

Group A: Circuit training

EXPERIMENTAL

Circuits Training Exercise Group

Other: Circuit Training

Group B: Progressive Resistance Exercise Group

ACTIVE COMPARATOR

Progressive Resistance Exercise Group

Other: Progressive Resistance

Interventions

1. Warm-up, balance 2. Aerobic, balance 3. Muscle strength Upper Limbs 4. Muscle strength Lower Limbs 5. Stretching both Upper Limb and Lower Limb

Group A: Circuit training

1. Muscle habituation exercises 2. Hypertrophic phase 1 exercises 3. Hypertrophic phase 2 exercises

Group B: Progressive Resistance Exercise Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabiliation Clinic

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (7)

  • Priego-Jimenez S, Torres-Costoso A, Guzman-Pavon MJ, Lorenzo-Garcia P, Luceron-Lucas-Torres MI, Alvarez-Bueno C. Efficacy of Different Types of Physical Activity Interventions on Exercise Capacity in Patients with Chronic Obstructive Pulmonary Disease (COPD): A Network Meta-Analysis. Int J Environ Res Public Health. 2022 Nov 5;19(21):14539. doi: 10.3390/ijerph192114539.

    PMID: 36361418BACKGROUND
  • Spielmanns M, Muller K, Schott N, Winkler A, Polanski H, Nell C, Boeselt T, Koczulla AR, Storre JH, Windisch W, Magnet FS, Baum K. [Impact of a Senso-Motoric Intervention in COPD-Patients Participating in an Outpatient Pulmonary Rehabilitation Program: A Randomized Controlled Trial]. Rehabilitation (Stuttg). 2017 Jun;56(3):159-166. doi: 10.1055/s-0042-119248. Epub 2017 Feb 23. German.

    PMID: 28231596BACKGROUND
  • Mazzarin CM, Silveira BR, Lamezon AC, Cavon Luna B, Valderramas S. Effectiveness and Safety of Multicomponent Physical Training in Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Clinical Trial. Health Serv Insights. 2023 May 2;16:11786329231169255. doi: 10.1177/11786329231169255. eCollection 2023.

    PMID: 37153879BACKGROUND
  • Spielmanns M, Gloeckl R, Gropp JM, Nell C, Koczulla AR, Boeselt T, Storre JH, Windisch W. Whole-Body Vibration Training During a Low Frequency Outpatient Exercise Training Program in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Trial. J Clin Med Res. 2017 May;9(5):396-402. doi: 10.14740/jocmr2763w. Epub 2017 Apr 1.

    PMID: 28392859BACKGROUND
  • Chao KY, Liu WL, Nassef Y, Lai PZ, Wang JS. A pilot crossover trial assessing the exercise performance patients chronic obstructive pulmonary disease. Sci Rep. 2022 Mar 9;12(1):4158. doi: 10.1038/s41598-022-07698-z.

    PMID: 35264615BACKGROUND
  • 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.

    PMID: 31805981BACKGROUND
  • 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.

    PMID: 28982202BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zubair Khalid, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

August 30, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations