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

NCT07709260 | Completed

• 1 other identifier: ISTU-WBVT-ILD25
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Diseases

Keywords

Interstitial Lung Disease; Whole-Body Vibration Training; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Six-Minute Walk Distance

  Functional exercise capacity assessed with the six-minute walk test according to ATS guidelines. Distance in meters will be recorded.

  Baseline and after 8 weeks

Secondary Outcomes (6)

• Forced Vital Capacity (FVC, % predicted)

  Baseline and 8 weeks

• Forced Expiratory Volume in 1 Second (FEV1, % predicted)

  Baseline and 8 weeks

• FEV1/FVC Ratio (%)

  Baseline and 8 weeks

• Partial Pressure of Oxygen (PaO2, mmHg)

  Baseline and 8 weeks

• Partial Pressure of Carbon Dioxide (PaCO2, mmHg)

  Baseline and 8 weeks

Study Arms (2)

Pulmonary Rehabilitation Only

ACTIVE COMPARATOR

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

Device: Inspiratory Muscle Training; Behavioral: Peripheral Muscle Strengthening Exercises; Behavioral: Aerobic Exercise Training (Cycle Ergometer)

Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT)

EXPERIMENTAL

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.

Device: Inspiratory Muscle Training; Behavioral: Peripheral Muscle Strengthening Exercises; Behavioral: Aerobic Exercise Training (Cycle Ergometer); Device: Whole-Body Vibration Training

Interventions

Inspiratory Muscle Training DEVICE

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.

Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT); Pulmonary Rehabilitation Only

Peripheral Muscle Strengthening Exercises BEHAVIORAL

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.

Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT); Pulmonary Rehabilitation Only

Aerobic Exercise Training (Cycle Ergometer) BEHAVIORAL

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.

Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT); Pulmonary Rehabilitation Only

Whole-Body Vibration Training DEVICE

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.

Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT)

Eligibility Criteria

• Age: 40 Months - 80 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi

Üsküdar, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study uses a single-blind design. Participants with interstitial lung disease are randomized into two parallel groups. The control group receives pulmonary rehabilitation only, including inspiratory muscle training, strengthening, and aerobic exercise twice weekly for 8 weeks. The experimental group receives the same rehabilitation program plus whole body vibration on a side-alternating platform (10-26 Hz). Outcome assessors are blinded to group allocation. Primary outcomes are changes in six-minute walk distance, pulmonary function (FVC, FEV₁, FEV₁/FVC), and arterial blood gases (PaO₂, PaCO₂, SaO₂, pH, HCO₃-). Secondary outcomes include dyspnea (mMRC, Borg scale), depression (BDI), and quality of life (SGRQ).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. Physiotherapist

Model Details: Participants with fibrotic interstitial lung disease (ILD), aged between 40 and 80 years, will be randomly assigned to two parallel groups using block randomization. The control group will receive a supervised pulmonary rehabilitation (PR) program consisting of inspiratory muscle training, peripheral muscle strengthening, and aerobic exercise. The intervention group will receive the same PR program plus whole body vibration (WBV) training delivered on a side-alternating vibration platform. Both groups will participate in supervised sessions twice per week for 8 weeks at the Chest Diseases Department of Sultan Abdulhamid Han Training and Research Hospital in Istanbul. The study follows a single-blind design in which outcome assessors will be blinded to group allocation. Clinical and functional outcomes, including pulmonary function tests, exercise capacity, arterial blood gases, dyspnea, depression, and quality of life, will be measured before and after the intervention to compare the

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: July 16, 2026
• Study Start: January 15, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)