Comparison of the Effects of Continuous Aerobic Exercise Training and High-Intensity Interval Exercise Training on ICF-Based Assessments in Lung Transplant Candidates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Cardiopulmonary exercise capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: LV-HIIT (Low-Volume High-Intensity Interval Training) (Behavioral)
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.
Intervention: Ergometer cycle (Device)
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.
Intervention: MICT (Moderate-Intensity Continuous Training) (Behavioral)
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.
Intervention: Ergometer cycle (Device)
Outcomes
Primary Outcomes
Cardiopulmonary exercise capacity
Time Frame: through study completion, an average of 1 year
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.
Submaximal exercise capacity
Time Frame: through study completion, an average of 1 year
-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.
Secondary Outcomes
- Fragility(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)
- Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry (Liters)(through study completion, an average of 1 year)
- Life Quality(through study completion, an average of 1 year)
- Balance(through study completion, an average of 1 year)
- Sarcopenia(through study completion, an average of 1 year)
- Respiratory Muscle Endurance(through study completion, an average of 1 year)
- Respiratory muscle strength(through study completion, an average of 1 year)
Investigators
Ulaş Ar
Principal Investigator
Ankara City Hospital Bilkent