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

NCT07065318 | Recruiting DMC

• 1 other identifier: TABED-2-24-305
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Keywords

lung transplant candidates; exercise training; high intensity interval training; aerobic exercise

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary exercise capacity

  Peak Work Rate (PWR) PWR is determined through a symptom-limited incremental bicycle ergometer test. Patients pedal at 10 W, increasing by 10 W each minute until fatigue or a workload of 50 W is reached, or a fatigue level of 9 on the modified Borg scale. Workload and heart rate are monitored, with maximum workload (Wpeak) and heart rate recorded at the end.

  through study completion, an average of 1 year

• Submaximal exercise capacity

  -Minute Walk Test (6MWT) The 6MWT assesses exercise capacity in a 30-meter corridor by measuring the distance walked. It evaluates oxygen saturation, heart rate, and dyspnea using the Borg scale before and after the test. Participants walk at their own pace and can pause or use oxygen as needed.

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry (Liters)

  through study completion, an average of 1 year

• Fragility

  through study completion, an average of 1 year

• Life Quality

  through study completion, an average of 1 year

• Kinesiophobia

  through study completion, an average of 1 year

• Muscle strength

  through study completion, an average of 1 year

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: LV-HIIT (Low-Volume High-Intensity Interval Training); Device: Ergometer cycle

MICT (Moderate-Intensity Continuous Training)

ACTIVE COMPARATOR

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.

Behavioral: MICT (Moderate-Intensity Continuous Training); Device: Ergometer cycle

Interventions

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

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

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

MICT (Moderate-Intensity Continuous Training) BEHAVIORAL

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

MICT (Moderate-Intensity Continuous Training)

Ergometer cycle DEVICE

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

LV-HIIT (Low-Volume High-Intensity Interval Training); MICT (Moderate-Intensity Continuous Training)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: men and women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 33115788 BACKGROUND

Study Officials

• Hatice K Kılıc, Prof. Dr.

  Ankara City Hospital Bilkent

  STUDY CHAIR

• Ebru CK Calık Kutukcu, Prof. Dr.

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Ulas A Ar, MSc

CONTACT

90 312-552-6000; ulas12ar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be 2 groups in the study. Group 1 will do low volume high-intensity interval exercise training. Group 2 will receive moderate-intensity continuous aerobic exercise training.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: July 15, 2025
• Study Start: November 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)