The Effects of Whole-Body Vibration Training on Clinical and Functional Outcomes in Individuals Diagnosed With Interstitial Lung Disease
The Effects of Whole-Body Vibration Training on Clinical and Functional Outcomes in Individuals Diagnosed With Interstitial Lung Disease: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the clinical and functional effects of Whole Body Vibration (WBV) training when added to a standard pulmonary rehabilitation (PR) program in patients with fibrotic interstitial lung disease (ILD). Participants aged between 40 and 80 years with confirmed ILD diagnosis will be randomly assigned to two groups: (1) PR only (control), and (2) PR + WBV (intervention). The program will last for 8 weeks, with supervised sessions twice per week.
Primary outcome measures include pulmonary function (FEV₁, FVC), exercise capacity (6-minute walk test), dyspnea (mMRC and Borg scale), arterial blood gas analysis, depression level (Beck Depression Inventory), and disease-specific quality of life (St. George's Respiratory Questionnaire). WBV will be performed using a side-alternating vibration platform starting at 10 Hz and progressively increased up to 24-26 Hz over 8 weeks. All procedures will follow ATS/ERS guidelines.
This study is conducted at the Chest Diseases Department of Sultan Abdulhamid Han Training and Research Hospital in Istanbul under the supervision of a multidisciplinary team. The goal is to determine whether WBV offers additional benefit in improving functional outcomes, respiratory performance, and quality of life in ILD patients undergoing PR.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
- 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.
- 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.
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.
- 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 $p < 0.05$.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Istanbul
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Üsküdar, Istanbul, Turquie (Türkiye)
- Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria
- Ages 40 to 80 years
- Diagnosis of fibrotic interstitial lung disease confirmed by a multidisciplinary council (e.g., idiopathic pulmonary fibrosis, idiopathic nonspecific interstitial pneumonia, sarcoidosis, or other fibrotic patterns)
- Receiving stable pharmacological treatment for at least 3 months (e.g., antifibrotic or immunosuppressive therapy)
- No acute exacerbation or upper respiratory tract infection within the past 4 weeks
- Able to safely participate in pulmonary rehabilitation and whole-body vibration training as determined by clinical evaluation
Exclusion Criteria:
- Pulmonary hypertension with systolic pulmonary artery pressure >65 mmHg
- Severe cardiovascular disease (e.g., uncontrolled hypertension, congestive heart failure, recent myocardial infarction)
- Advanced renal or hepatic failure
- Balance disorders preventing safe standing on a vibration platform
- Severe musculoskeletal limitations (e.g., advanced arthritis, severe osteoporosis, high fall risk)
- Advanced cognitive impairment or dementia
- Severe psychiatric disorders (e.g., severe depression or anxiety)
- Neurological diseases interfering with participation or test performance
- Participation in a pulmonary rehabilitation program during the study or within the past 6 months
- Pregnancy or breastfeeding
- Uncontrolled metabolic diseases (e.g., advanced diabetes, uncontrolled thyroid dysfunction)
- Vestibular system disorders
- Active malignancy
- Presence of a pacemaker or other contraindicated implanted electronic devices
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Pulmonary Rehabilitation Only
Participants in this group will receive a supervised pulmonary rehabilitation (PR) program consisting of inspiratory muscle training, peripheral muscle strengthening exercises, aerobic exercise training, and breathing techniques (diaphragmatic breathing, pursed-lip breathing, and active cycle of breathing techniques). The PR program will be administered twice weekly for 8 weeks under clinical supervision. Intervention Names included in this Arm (must match Intervention list): Inspiratory Muscle Training Peripheral Muscle Strengthening Exercises Aerobic Exercise Training (Cycle Ergometer) Breathing Techniques |
Inspiratory muscle training performed using the PowerBreathe Medic Plus device twice weekly for 8 weeks.
Training follows a 5 breaths × 6 sets protocol, with the initial load set to achieve an RPE of 3-4 on the Modified Borg Scale.
Load is increased weekly by 5-10% according to patient tolerance.
Resistance exercises targeting the quadriceps, shoulder flexors, and shoulder abductors performed at an RPE of 3-4, for 2 sets of 8 repetitions.
Sessions occur twice weekly for 8 weeks under supervision.
Aerobic exercise performed on a cycle ergometer at 60-80% of the target heart rate calculated using the Karvonen formula.
Each session includes 3 minutes warm-up, 15 minutes active exercise, and 3 minutes cool-down (total 21 minutes).
Resistance is adjusted weekly by 5-10% to maintain an RPE of 3-4.
Conducted twice weekly for 8 weeks.
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Expérimental: Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT)
Participants in this arm will receive a supervised pulmonary rehabilitation program consisting of inspiratory muscle training, peripheral muscle strengthening exercises, aerobic exercise training, and breathing techniques, administered twice weekly for 8 weeks.
In addition, they will receive whole-body vibration training using a side-alternating vibration platform (Power Plate ProXG10).
Vibration training will start at 10 Hz and progressively increase to 24-26 Hz over 8 weeks, performed as 2-3 sets of 3 minutes each, targeting an RPE of 3-4.
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Inspiratory muscle training performed using the PowerBreathe Medic Plus device twice weekly for 8 weeks.
Training follows a 5 breaths × 6 sets protocol, with the initial load set to achieve an RPE of 3-4 on the Modified Borg Scale.
Load is increased weekly by 5-10% according to patient tolerance.
Resistance exercises targeting the quadriceps, shoulder flexors, and shoulder abductors performed at an RPE of 3-4, for 2 sets of 8 repetitions.
Sessions occur twice weekly for 8 weeks under supervision.
Aerobic exercise performed on a cycle ergometer at 60-80% of the target heart rate calculated using the Karvonen formula.
Each session includes 3 minutes warm-up, 15 minutes active exercise, and 3 minutes cool-down (total 21 minutes).
Resistance is adjusted weekly by 5-10% to maintain an RPE of 3-4.
Conducted twice weekly for 8 weeks.
Whole-body vibration training performed using the Power Plate ProXG10 Acceleration Pro series device, twice weekly for 8 weeks.
Sessions include warm-up, vibration training, and cool-down components.
Vibration begins at 10 Hz and increases gradually by 2-3 Hz each week, reaching 24-26 Hz by week 8. Amplitude is maintained at 4-6 mm.
WBVT is applied as 2 sets × 3 minutes initially, with 2 minutes rest between sets, progressing to 3 sets × 3 minutes from week 5 onward.
Participants stand barefoot with slight knee flexion (approximately 150°) while maintaining an RPE of 3-4.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Six-Minute Walk Distance
Délai: Baseline and after 8 weeks
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Functional exercise capacity assessed with the six-minute walk test according to ATS guidelines.
Distance in meters will be recorded.
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Baseline and after 8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Forced Vital Capacity (FVC, % predicted)
Délai: Baseline and 8 weeks
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Pulmonary function will be evaluated by spirometry according to ATS/ERS standards.
FVC (% predicted) will be recorded.
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Baseline and 8 weeks
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Forced Expiratory Volume in 1 Second (FEV1, % predicted)
Délai: Baseline and 8 weeks
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Spirometry measurement of FEV1 (% predicted).
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Baseline and 8 weeks
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FEV1/FVC Ratio (%)
Délai: Baseline and 8 weeks
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Ratio of forced expiratory volume in one second to forced vital capacity.
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Baseline and 8 weeks
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Partial Pressure of Oxygen (PaO2, mmHg)
Délai: Baseline and 8 weeks
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Resting arterial blood gas analysis, measuring oxygen tension (PaO2).
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Baseline and 8 weeks
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Partial Pressure of Carbon Dioxide (PaCO2, mmHg)
Délai: Baseline and 8 weeks
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Resting arterial blood gas analysis measuring PaCO2.
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Baseline and 8 weeks
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Blood pH
Délai: Baseline and 8 weeks
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Arterial blood gas analysis measuring systemic pH.
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Baseline and 8 weeks
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ISTU-WBVT-ILD25
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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