NCT07065318

Lung Transplant Candidates: Effects of Aerobic vs. HIIT Training on ICF Assessments

Comparison of the Effects of Continuous Aerobic Exercise Training and High-Intensity Interval Exercise Training on ICF-Based Assessments in Lung Transplant Candidates

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Lung transplantation is a crucial surgical intervention aimed at increasing survival rates in patients with end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis, and pulmonary hypertension. One of the most important determinants of health outcomes before and after lung transplantation is exercise capacity. An increase in the 6-minute walking distance (6MWD), which serves as a measure of functional exercise capacity, is associated with lower mortality rates in both pre- and post-transplantation settings. Therefore, effective rehabilitation programs are needed to enhance the exercise capacities of lung transplant candidates. Pulmonary rehabilitation (PR) is a comprehensive program designed specifically for individuals with chronic respiratory diseases. PR aims to improve patients\' physical and psychological conditions through detailed assessments and personalized treatment plans. It can play a role in enhancing the preoperative exercise capacities of lung transplant candidates and improving their chances of successful health outcomes. However, lung transplant candidates often have more advanced lung disease and face greater challenges compared to typical patients undergoing PR, making the expected benefits more complex to achieve. The primary aim of this study is to investigate the effects of high-intensity interval training (HIIT) in lung transplant candidates with interstitial lung disease (ILD). The first objective is to compare the physiological responses and effectiveness of HIIT and moderate-intensity continuous training (MICT) within the same exercise volume. The secondary aim is to evaluate the impact of HIIT on body structure and function, activity, and participation levels using ICF-based assessments.

Detailed description

Research Design This study employs a randomized controlled prospective design. The exercise training protocol consists of two main groups: high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT). The HIIT protocol includes high-intensity efforts performed in 30-second intervals, while the MICT protocol involves longer-duration, moderate-intensity exercise. The total training duration for both groups is planned for 8 weeks. Participants will include individuals with interstitial lung disease who are on the waiting list for lung transplantation. They must agree to participate regularly in the exercise program. Power analysis indicated that a minimum of 17 participants per group is needed, leading to a total target of 34 participants. Parameters to be Assessed The study will assess various parameters before and after the exercise training. These parameters include demographic information, exercise capacity, respiratory function, comorbidities, daily living activities, and quality of life. Exercise capacity will be evaluated using the 6-minute walk test (6MWT). Respiratory functions will be measured through pulmonary function tests (PFT), capturing values such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and carbon monoxide diffusion capacity (DLCO). Comorbidities will be assessed using the Charlson Comorbidity Index, while daily living activities will be measured using the London Chest and St. George questionnaires. Quality of life will be evaluated through various scales. For instance, the Tampa Kinesiophobia Scale will assess fear and anxiety levels in patients. Additionally, the FRAIL Scale will evaluate frailty, sarcopenia levels, and muscle strength. Hypotheses This study has four main hypotheses: There is a significant difference between HIIT and MICT regarding the effects on body structure and function impairments, activity, and participation levels. HIIT has a positive effect on respiratory function, exercise capacity, and quality of life. HIIT has an effect on sarcopenia and frailty levels. HIIT impacts body structure and function impairments, activity, and participation levels. Conclusion This study aims to evaluate the effects of high-intensity interval training in lung transplant candidates. The findings may contribute to optimizing pre-transplant rehabilitation processes and improving the overall health status of these patients. Furthermore, the applicability and effectiveness of such exercise protocols may lead to significant changes in clinical practice. The results of the research will shed light on the development of exercise rehabilitation programs and the treatment processes for lung disease patients.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
BEHAVIORAL	LV-HIIT (Low-Volume High-Intensity Interval Training)	30-sec intervals at 85-100% peak workload, 30-sec rest at 40%, total 20-30 min.
BEHAVIORAL	MICT (Moderate-Intensity Continuous Training)	Continuous cycling at 60-80% peak workload for 20-30 min.
DEVICE	Ergometer cycle	Electronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Turkey (Türkiye)