High Intensity Interval Training and Inspiratory Muscle Training

NCT06836895 | Completed

• 1 other identifier: COPD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (5)

• Pulmonary function tests (FEV1, FVC, TLC, IC, FRC, RV) in liter

  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).

  8 weeks

• Pulmonary function test (FEV1/FVC, RV/ TLC, DLCO, SpO2rest) in percentage

  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

  8 weeks

• Pulmonary function tests (PaO2rest, PaCO2rest) in mmHg

  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

  8 weeks

• Exercise capacity (peak workload (WRpeak) in watt

  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

  8 weeks

• Functional exercise capacity (six minute walk distance) in meters

  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).

  8 weeks

Secondary Outcomes (2)

• Health-related quality of life

  8 weeks

• Dyspnea

  8 weeks

Study Arms (2)

study

EXPERIMENTAL

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.

Behavioral: HIIT and IMT

control

EXPERIMENTAL

therapeutic education and self-based walking for 30 minutes

Other: walking

Interventions

HIIT and IMT BEHAVIORAL

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.

study

walking OTHER

30-min walking

control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Prince Sattam Binabdulaziz University

Riyadh, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

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: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 20, 2025
• Study Start: June 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)