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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorAnkara City Hospital Bilkent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • MICT (Moderate-Intensity Continuous Training)

    Behavioral

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

  • Ergometer cycle

    Device

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: LV-HIIT (Low-Volume High-Intensity Interval Training)Experimental treatment 2 interventions
Group B: MICT (Moderate-Intensity Continuous Training)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 year
2

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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

FEV1 will be assessed via CosmedQuark PFT Q-Box, Italy following. Participants will perform ≥3 reproducible maneuvers; the highest value within 5% repeatability will be recorded and reported in liters. Values will be expressed as absolute liters and % predicted using equation.

Time frame
through study completion, an average of 1 year
2

Fragility

Frail Frailty Scale It is a scale that evaluates the patient\'s fatigue, resistance, mobility, weight loss and other diseases by questioning them. The FRAIL scale, which consists of 5 items, receives 0 or 1 points according to the answers given by the patients, and a total of 0 points is considered as non-frail, 1-2 points as pre-frail and \>2 points as frail.

Time frame
through study completion, an average of 1 year
3

Life Quality

St George Quality of Life Questionnaire It is a scale that measures the quality of life specific to respiratory diseases. It consists of a total of 50 items, 8 of which question the patient\'s symptoms, 16 of which question the activities, and 26 of which question the effects of the disease. While evaluating the symptoms, the patient\'s level of shortness of breath, cough, and sputum respiratory discomfort are questioned. While evaluating the activity component, physical activities that cause shortness of breath or are restricted due to shortness of breath are questioned. While evaluating the effects of the disease, it includes factors such as work, occupation, keeping health under control, and discomfort during daily living activities. The 3 sections of the test are calculated separately and the total score is calculated. A score of 0 indicates normal, a score of 100 indicates maximum disability

Time frame
through study completion, an average of 1 year
4

Kinesiophobia

The Tampa Scale for Kinesiophobia (TSK) is a validated 17-item questionnaire assessing fear of movement and reinjury in chronic pain patients, scored on a 4-point Likert scale (1=strongly disagree to 4=strongly agree). Total scores range from 17 (no kinesiophobia) to 68 (severe kinesiophobia), with scores ≥38 indicating clinically significant fear that may impair recovery.

Time frame
through study completion, an average of 1 year

Other outcomes

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