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Interstitial Lung DiseasesNCT07709260

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

A study testing Inspiratory Muscle Training, Peripheral Muscle Strengthening Exercises and Aerobic Exercise Training (Cycle Ergometer) in people with Interstitial Lung Diseases, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 80 months
Conditions the study is for
Interstitial Lung Diseases
What is being tested?
Inspiratory Muscle Training, Peripheral Muscle Strengthening Exercises and Aerobic Exercise Training (Cycle Ergometer)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sultan 2. Abdülhamid Han Eğitim ve Araştırma Hastanesi

    Üsküdar, Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description
  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 $p < 0.05$.
Being tested
Inspiratory Muscle Training, Peripheral Muscle Strengthening Exercises, Aerobic Exercise Training (Cycle Ergometer), Whole-Body Vibration Training
Keywords
Interstitial Lung Disease, Whole-Body Vibration Training, Exercise
Medical subject headings
Lung Diseases, Interstitial, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory Muscle TrainingDevice

    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.

  • Peripheral Muscle Strengthening ExercisesBehavioural

    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 Training (Cycle Ergometer)Behavioural

    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 TrainingDevice

    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.

Study groups in NCT07709260
Study groupRoleWhat they receive
Pulmonary Rehabilitation OnlyActive comparatorParticipants 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
Receives: Device: Inspiratory Muscle Training; Behavioral: Peripheral Muscle Strengthening Exercises; Behavioral: Aerobic Exercise Training (Cycle Ergometer)
Pulmonary Rehabilitation + Whole-Body Vibration Training (WBVT)ExperimentalParticipants 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.
Receives: Device: Inspiratory Muscle Training; Behavioral: Peripheral Muscle Strengthening Exercises; Behavioral: Aerobic Exercise Training (Cycle Ergometer); Device: Whole-Body Vibration Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and after 8 weeks

Secondary outcomes (6)

  1. Forced Vital Capacity (FVC, % predicted)

    Pulmonary function will be evaluated by spirometry according to ATS/ERS standards. FVC (% predicted) will be recorded.

    Measured: Baseline and 8 weeks

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

    Spirometry measurement of FEV1 (% predicted).

    Measured: Baseline and 8 weeks

  3. FEV1/FVC Ratio (%)

    Ratio of forced expiratory volume in one second to forced vital capacity.

    Measured: Baseline and 8 weeks

  4. Partial Pressure of Oxygen (PaO2, mmHg)

    Resting arterial blood gas analysis, measuring oxygen tension (PaO2).

    Measured: Baseline and 8 weeks

  5. Partial Pressure of Carbon Dioxide (PaCO2, mmHg)

    Resting arterial blood gas analysis measuring PaCO2.

    Measured: Baseline and 8 weeks

  6. Blood pH

    Arterial blood gas analysis measuring systemic pH.

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start15 Jan 2026
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709260
Sponsor's protocol ID
ISTU-WBVT-ILD25
Status last verified
Jul 2026
First submitted
24 Aug 2025
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory Muscle Training, Peripheral Muscle Strengthening Exercises and Aerobic Exercise Training (Cycle Ergometer) in people with Interstitial Lung Diseases, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Six-Minute Walk Distance (time frame: Baseline and after 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07709260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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