The Effect of Combined High Intensity Interval Training and Inspiratory Muscle Training on Pulmonary Function and Exercise Capacity in COPD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pulmonary function tests (FEV1, FVC, TLC, IC, FRC, RV) in liter
Study Overview
Brief Summary
The goal of this clinical trial is to investigate the effect of combined high intensity interval training (HIIT) and inspiratory muscle training (IMT) on pulmonary function and exercise capacity in patients COPD. one hundred patients with COPD (GOLD II and III) with ages between 40 and 70 years participated in this study. The main question it aims to answer is whether combined high intensity interval training (HIIT) and inspiratory muscle training (IMT) have effect on pulmonary function and exercise capacity Pulmonary function tests, incremental cycle ergometer tests, 6 min walk tests and inspiratory muscle strength were performed and dyspnea and Health-related quality of life (HRQoL) were assessed before and after the intervention period.
Detailed Description
METHODS Study Design This study was performed as a randomized, controlled trial over 8 weeks and included two groups. The study procedures were carried out in the Department of Rehabilitation and Health Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia between June 2024 and October 2024 Ethical consideration The study protocol was approved by the Standing Committee of Bioethics Research in Prince Sattam bin Abdulaziz University, Saudi Arabia (ID: SCBR-359/2024). The study was conducted in line with the principles of the Declaration of Helsinki. All study participants have signed a written informed consent form. The aim, procedures and potential risks of the study were explained to the study population.
Randomization A researcher, uninvolved in any other aspect of this study, conducted randomization by creating a block randomization schedule without stratifications. Initially, randomization codes were generated using Microsoft Excel (Microsoft Corporation, Redmond, WA). The allocation was then concealed in sequentially numbered, sealed, non-transparent envelopes. Eligible participants were subsequently directed to a researcher responsible for overseeing treatment, who assigned them randomly to either the study or control group.
Subjects:
A total of 144 clinically stable patients with COPD were recruited from local health facilities and nearby hospitals and clinics through advertisements to participate in this study and 100 completed the study follow-up.
The inclusion criteria were: 1) diagnosis of mild-to-severe COPD according to guidelines criteria with mild or severe airflow obstruction (GOLD II and III) (20), 2) Age ≥40 but ≤70 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of mild-to-severe COPD according to guidelines criteria with mild or severe airflow obstruction (GOLD II and III)
- •Age ≥40 but ≤70 years.
- •Body mass index between 18 kg/m2 and <30 kg/m2,
Exclusion Criteria
- •any musculoskeletal, cardiovascular, or neurologic diseases that prohibited participating in HIIT,
- •Exacerbation of COPD,
- •Participation in a pulmonary rehabilitation program or organized exercise training in the last 6 months.
Arms & Interventions
control
therapeutic education and self-based walking for 30 minutes
Intervention: walking (Other)
study
The study group (n=50) underwent 8 weeks combined HIIT and IMT. The HIIT protocol involved four intervals, each lasting 4 minutes, beginning at 70% of maximum power and building to a target intensity of at least 85% HRmax. The IMT sessions included 2-3 sets of 30 breaths (totaling 60-90 breaths per session), with a two-minute rest between sets, three days per week starting with 30% of PImax and reaching 60% of PImax.
Intervention: HIIT and IMT (Behavioral)
Outcomes
Primary Outcomes
Pulmonary function tests (FEV1, FVC, TLC, IC, FRC, RV) in liter
Time Frame: 8 weeks
Lung function test was carried out by the same experienced personnel using Master Screen Body® Jaeger-Carefusion spirometer (22745 Savi Ranch Parkway, Yorba Linda, CA, USA). The test was repeated until three acceptable spirograms were obtained. A spirogram was considered acceptable if it was artifact-free, demonstrated adequate expiration, had a 6-second plateau at the end of the forced expiratory phase, and showed proper patient compliance. Measurements included FEV1, forced vital capacity, total lung capacity, and residual volume (22).
Pulmonary function test (FEV1/FVC, RV/ TLC, DLCO, SpO2rest) in percentage
Time Frame: 8 weeks
Lung function test was carried out by the same experienced personnel using Master Screen Body® Jaeger-Carefusion spirometer (22745 Savi Ranch Parkway, Yorba Linda, CA, USA). The pulmonary function test procedures were conducted repeatedly until three satisfactory spirograms were obtained. A spirogram was considered acceptable if it was artifact-free, demonstrated adequate expiration, exhibited final forced expiratory phase plateau lasting 6 seconds, and reflected proper patient cooperation. Measurements of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), total lung capacity (TLC), and residual volume (RV) were taken (22). The single-breath technique was implemented to measure the diffusing capacity of the lung for carbon monoxide (DLco) using Master Screen Body® Jaeger-Carefusion spirometer (22745 Savi Ranch Parkway, Yorba Linda, CA, USA) (23). The pulmonary function parameters were recorded as absolute values and percentage of predicted according to participa
Pulmonary function tests (PaO2rest, PaCO2rest) in mmHg
Time Frame: 8 weeks
Lung function test was carried out by the same experienced personnel using Master Screen Body® Jaeger-Carefusion spirometer (22745 Savi Ranch Parkway, Yorba Linda, CA, USA). The pulmonary function test procedures were conducted repeatedly until three satisfactory spirograms were obtained. A spirogram was considered acceptable if it was artifact-free, demonstrated adequate expiration, exhibited final forced expiratory phase plateau lasting 6 seconds, and reflected proper patient cooperation. Measurements of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), total lung capacity (TLC), and residual volume (RV) were taken (22). The single-breath technique was implemented to measure the diffusing capacity of the lung for carbon monoxide (DLco) using Master Screen Body® Jaeger-Carefusion spirometer (22745 Savi Ranch Parkway, Yorba Linda, CA, USA) (23). The pulmonary function parameters were recorded as absolute values and percentage of predicted according to participa
Exercise capacity (peak workload (WRpeak) in watt
Time Frame: 8 weeks
To measure peak workload (WRpeak), an incremental cycle ergometer test was conducted on a motorized cycle ergometer (Kettler ErgoRace, Virginia Beach, VA). Continuous ECG-registration was maintained throughout the test. The initial pedaling load was 20W, with the resistance increasing by 10W each minute until they reached exhaustion
Functional exercise capacity (six minute walk distance) in meters
Time Frame: 8 weeks
The six minute walk test (6MWT) was used to evaluate the functional exercise capacity. A 30 m long flat corridor was used to conduct the test according to the American Thoracic Society guidelines (30). Assessment of heart rate, respiratory rate, oxygen saturation, and dyspnea were performed before and after testing. Before beginning the test, patients received instructions on the proper test procedures. Each patient was verbally encouraged every minute during the test. Patients performed the test twice, with the initial trial done to familiarize them with the test procedures and was not recorded (31).
Secondary Outcomes
- Health-related quality of life(8 weeks)
- Dyspnea(8 weeks)
Investigators
Ahmad Saied Mohammad
Dr
Prince Sattam Bin Abdulaziz University