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

NCT ID: NCT07065318

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LV-HIIT (Low-Volume High-Intensity Interval Training)

The first randomly assigned group will perform 30 seconds of high-intensity exercise at 85-100% of their maximum workload, followed by 30 seconds of exercise at 40% of their maximum workload. This 30-second high-intensity exercise followed by 30 seconds of low-intensity exercise will be referred to as one cycle. A total of 20 cycles will be completed. Additionally, 2 minutes of low-intensity warm-up and cool-down exercises will be performed.

Group Type: EXPERIMENTAL

LV-HIIT (Low-Volume High-Intensity Interval Training)

Intervention Type: BEHAVIORAL

30-sec intervals at 85-100% peak workload, 30-sec rest at 40%, total 20-30 min.

Ergometer cycle

Intervention Type: DEVICE

Electronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial.

MICT (Moderate-Intensity Continuous Training)

The second group determined as a result of randomization will exercise for 20-30 minutes at 60-80% of maximum workload. Exercise volume (duration × %Wpeak) matched between groups.

Group Type: ACTIVE_COMPARATOR

MICT (Moderate-Intensity Continuous Training)

Intervention Type: BEHAVIORAL

Continuous cycling at 60-80% peak workload for 20-30 min.

Ergometer cycle

Intervention Type: DEVICE

Electronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial.

Interventions

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.

Intervention Type: BEHAVIORAL

MICT (Moderate-Intensity Continuous Training)

Continuous cycling at 60-80% peak workload for 20-30 min.

Intervention Type: BEHAVIORAL

Ergometer cycle

Electronically Ergometer cycle custo ec5000, CustoMed used for all exercise sessions. Calibrated before each trial.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being diagnosed with interstitial lung disease and being followed up at the Ankara City Hospital Chest Diseases Clinic,
• Being 18 years of age or older,
• Patients who are being followed up with a diagnosis of ILD according to the ATS/ERS 2022 international ILD guideline,
• Being on the lung transplant waiting list according to the International Society for Heart and Lung Transplantation and are being evaluated for listing and are being followed up by the chest diseases department (25-28),
• Being willing to participate in the exercise program regularly and volunteering to participate in the study,
• Patients who have dyspnea levels of 2 and above according to the Modified Medical Research Council dyspnea scale and are able to ambulate,
• Patients who receive long-term oxygen support will be included.

Exclusion Criteria

• Patients with a history of exertional syncope,
• Patients in acute exacerbation,
• Patients with sarcoidosis,
• Patients with serious comorbidities that may limit exercise (e.g. musculoskeletal, neurological or cardiovascular problems) will not be included.
• Patients with an aortic aneurysm greater than 5.5 cm,
• Patients with cardiovascular impediments to exercise during cardiological evaluations prior to pulmonary rehabilitation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Ulaş Ar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice K Kılıc, Prof. Dr.

Role: STUDY_CHAIR

Ankara City Hospital Bilkent

Ebru CK Calık Kutukcu, Prof. Dr.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Ankara Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ulas A Ar, MSc

Role: CONTACT

ulas12ar@gmail.com

90 312-552-6000

Facility Contacts

Ankara Bilkent City Hospital H H, H

Role: primary

References

Hume E, Ward L, Wilkinson M, Manifield J, Clark S, Vogiatzis I. Exercise training for lung transplant candidates and recipients: a systematic review. Eur Respir Rev. 2020 Oct 28;29(158):200053. doi: 10.1183/16000617.0053-2020. Print 2020 Dec 31.

Reference Type: BACKGROUND

PMID: 33115788 (View on PubMed)

Other Identifiers

TABED-2-24-305

Identifier Type: -

Identifier Source: org_study_id