The Effects of Whole-Body Vibration Training on Clinical and Functional Outcomes in Individuals Diagnosed With Interstitial Lung Disease: A Randomized Controlled Trial

1. Study Background and Aim Interstitial lung disease (ILD) is characterized by inflammation and progressive fibrosis, leading to restrictive respiratory patterns, exertional dyspnea, and reduced exercise capacity. While pulmonary rehabilitation (PR) is a cornerstone of clinical management, data regarding the efficacy of Whole-Body Vibration Training (WBVT) in this population remain limited. The aim of this study is to investigate the effectiveness of WBVT applied in addition to a routine PR program consisting of respiratory muscle training, peripheral muscle training, and aerobic exercise in individuals with ILD. This randomized controlled trial comprehensively evaluates the clinical and functional effects of WBVT, focusing on lung functions, functional exercise capacity, gas exchange capacity via arterial blood gas analysis, multidimensional dyspnea levels, psychological status, and quality of life.
2. Study Design and Population This is a two-arm, prospective, randomized controlled trial conducted at the Pulmonary Rehabilitation Unit of the Pulmonology Department at Istanbul Sultan Abdülhamid Han Training and Research Hospital. Patients aged 40-80 years diagnosed with ILD will be screened. Following cardiovascular suitability clearance by a cardiologist, participants will be randomly assigned to either the Control Group (PR alone) or the Study Group (PR + WBVT) using a computer-based block randomization method. All procedures align with the Declaration of Helsinki, and written informed consent will be obtained.
3. INTERVENTIONS 3.1. Control Group (CG) - Standard Pulmonary Rehabilitation Participants in the control group will receive a supervised standard pulmonary rehabilitation (PR) program twice a week for 8 weeks. This program includes active cycle of breathing, diaphragmatic, and pursed-lip breathing techniques, alongside three structured training modalities. First, Inspiratory Muscle Training will be performed using the Powerbreathe Medic Plus (gray) device twice weekly, with the initial load set at a rating of perceived exertion (RPE) of 3-4 on the Modified Borg Scale and increased by 5-10% weekly (5 breaths × 6 sets). Second, Peripheral Muscle Training will target the quadriceps, shoulder flexors, and shoulder abductors at an RPE of 3-4, structured as 2 sets of 8 repetitions. Third, the Aerobic Exercise Program will be conducted on a cycle ergometer twice weekly for 21 minutes (3-minute warm-up, 15-minute target-intensity, and 3-minute cool-down) at 60-80% of the target heart rate calculated via the Karvonen formula, with pedal resistance adjusted weekly by 5-10% to maintain an RPE of 3-4.

3.2. Study Group (SG) - Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT)Participants in the study group will receive the identical 8-week standard PR program described for the control group, combined with a supervised WBVT protocol performed twice a week using the Power Plate ProXG10 Acceleration Pro series platform. During WBVT, participants stand barefoot on the platform with slight knee flexion (~150°). Each session begins with a 5-minute warm-up (low-intensity treadmill walking/cycling and stretching) and concludes with a 5-minute cool-down consisting of static stretching. For the first 4 weeks, WBVT will be applied as 2 sets of 3 minutes with 2-minute rest intervals, starting at a frequency of 10 Hz and increasing by 2-3 Hz weekly based on tolerance. From week 5 through week 8, the training volume will increase to 3 sets of 3 minutes, progressively raising the frequency to reach a target of 24-26 Hz. The vibration amplitude will be kept constant at approximately 4-6 mm throughout the entire 8-week intervention. 4. STATISTICAL METHODOLOGY Sample Size and Statistical Analysis Based on a two-tailed independent samples t-test for the primary outcome, assuming a significance level of $\alpha = 0.05$, a statistical power ($1-\beta$) of 0.80, and an expected effect size of Cohen's $d = 1.15$ calculated via G*Power 3.1, a minimum sample size of 26 participants (13 per group) is required. To account for a potential 15% attrition rate, additional participants will be recruited. Statistical analysis will be performed using IBM SPSS Statistics V26.0 software. Normality will be assessed with the Shapiro-Wilk test. Continuous variables will be analyzed using Mixed Design ANOVA or appropriate parametric/non-parametric tests (Student's t-test, Paired t-test, Mann-Whitney U, Wilcoxon signed-rank) depending on the distribution of the data, with statistical significance set at $p < 0.05$.