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Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT03560154
Recruitment Status : Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Nur Selin Of, Istanbul University

Brief Summary:

Interstitial lung disease (ILD) is a diverse group of parenchymal lung disorders characterized by restrictive lung function and impaired alveolar diffusion capacity, leading to dyspnea on exertion, reduced exercise endurance, and poor quality of life. Patients usually complain of progressive breathlessness, persisting non-productive cough, which occurs with exercise. Hemoptysis, fever, chest pain are also seen. The most common comorbidity in chronic lung diseases is the progressive loss of exercise tolerance. Not only dyspnea, but also peripheral muscle dysfunction and cognitive deficits such as, anxiety and depression are responsible for the reduction of mobility in the patient. In the context of pulmonary rehabilitation (PR) program to be applied in interstitial lung diseases; upper and lower limb endurance, stretching and relaxation techniques, aerobic exercise training, respiratory muscle training, training of energy conservation methods, support by determining oxygen requirement, nutritional evaluation, prevention of weight and muscle loss, psycho-social support. The purpose of PR programs in this disease is; to improve muscle strength, endurance, and mechanical activity, to improve dyspnea sensation, to improve functional capacity, to inform and educate the patient about the patient's disease. The use of whole body vibration (TVT) is an increasingly common method of therapeutic use in order to improve neuromuscular performance. TVT applications have shown that increases muscle activity, muscle strength and muscle strength, improves lower extremity blood circulation and balance, and increases growth hormone production. TVT training effects have rarely been studied in patients with pulmonary disease. Muscle strength and performance enhancement were significant effects of TVT, which was emphasized as a promising exercise method for those with chronic obstructive pulmonary disease (COPD). Over the past decade, endurance and strength training has been established as the most important components of exercise training programs in patients with COPD and ILD. Therefore, inclusion of TVT into exercise training programs in ILD patients may lead to beneficial results.

The investigators hypotheses are:

  1. the combination of home respiratory exercises with whole body vibration training may lead to more improved respiratory muscle strength, dyspnoea, functional capacity, balance, peripheral muscle strength and quality of life in ILD patients
  2. when applied as an isolated intervention, home respiratory exercises programme may lead to lower results than combination programs.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Scleroderma Idiopathic Pulmonary Fibrosis Other: Whole Body Vibration Training Not Applicable

Detailed Description:

Patients:

All participants with ILD will be recruited from a Cerrahpasa Medical Faculty Hospital between January 2017 and June 2018. All treatments will performed in the same hospital.

Sample Size:

"Power and Sample Size Program" was used to calculate sample size. Power analysis was done with Pass 11 Home program. In the power analysis program, α = 0,05, β = 0,15 1- β = 0,84. When the number of samples of the groups was 30 and 30, 84% power was obtained. Using a two-sided two-sample t-test, the standard deviations from the 0,05 alpha value are 7.0 and 6.0.

Procedure:

A list of individuals diagnosed with interstitial lung disease who are following the outpatient clinic of the Department of Chest Diseases of the Istanbul University Cerrahpaşa Medical Faculty and who meet the inclusion criteria for the study will be created. The created patient list will be enumerated. Two groups will be formed from the numbered persons by the random number table method (n = 60). Groups will receive 30 participants in the treatment group, whose protocol numbers end in an even number, and 30 members in the control group, who finished with an odd number of protocol numbers. Up to 10% of the sample size will be selected as a substitute, taking into account the non-participation of the selected individuals in the study.

Assessments at baseline and after training will be performed by pulmonary physiotherapist. All the participants will be treated in the Cerrahpaşa Medical Faculty hospital by a physiotherapist who is experienced in pulmonary rehabilitation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease: A Randomized Controlled Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: Whole Body Vibration Training
whole body vibration application will be performed in the range of 25-40 Hz, with amplitude 1-2 mm, 30-60 seconds (30-45 seconds) application and resting times of 60 seconds, 2-5 sets each session. In TVT training; Eight kinds of exercises will be provided, including 3 sessions per week for 4 weeks. The duration of each session will vary between 8-30 minutes. The frequency, amplitude, and duration of the TVT will be gradually increased from the lowest intensity to the level that the patient can tolerate. 8 exercises will be applied: for lower extremity; high squat, deep squat, right/left lunge, calf raise, for upper extremity; front raise, bent over lateral, biceps curl, and cross over. Before TVT application, 5-8 min. warm-up exercises will be applied. If desaturation (<88%) develops during the training in the patient, an oxygen mask will be used to ensure adequate oxygenation. Also, as a home program; respiratory exercises will be taught every day of the week for 10 minutes a day.
Other: Whole Body Vibration Training
whole body vibration application will be performed in the range of 25-40 Hz, with amplitude 1-2 mm, 30-60 seconds (30-45 seconds) application and resting times of 60 seconds, 2-5 sets each session. Also, as a home program; respiratory exercises will be taught every day of the week for 10 minutes a day.

No Intervention: Home respiratory exercises
Respiratory exercises will be taught to the patient. Duration of the respiratory exercises is at least 10 minute per session, 7 days a week for 4 weeks. A weekly phone call will be provided and exercise will be followed.



Primary Outcome Measures :
  1. Pulmonary Function Test [ Time Frame: 4 weeks ]
    The pulmonary function test (PFT) will be performed with a portable spirometry device (Spirobank II) with the nose closed and at least three times in the sitting position. After the nose is tightened with a latch, the person breathes normally on the spirometer. After a few normal inspirations and expirations, it is desirable to take a deep breath at the end of the expiration at the level of rest, and to release the air slowly and continuously afterwards. With this application, the volumes and capacities outside the residual volume (RV), functional residual capacity (FRC) and total lung capacity (TLC) are calculated.

  2. Diffusing capacity for carbon monoxide (DLCO) [ Time Frame: 4 weeks ]
    The single breath carbon monoxide diffusion test method will be used to calculate the diffusion capacity. Carbonmonoxide Diffusion (DLCO) measurement is an important noninvasive test that provides information on pulmonary gas exchange. The CO concentrations are measured by passing the analyzer through a breathing air analyzer of the patient, which is then exhaled into the device; the amount of CO transferred to the blood is calculated from the difference between the inspired air and the CO concentrations in the expired air.

  3. Respiratory muscle strength [ Time Frame: 4 weeks ]
    Respiratory muscle strength will be measured using a portable electronic mouth measuring instrument (MicroRPM; Micro Medical, UK). Maximum inspiratory (MIP) and expiratory (MEP) pressures are noninvasive tests that indirectly indicate respiratory muscle strength. It is the intraoral pressure measured during maximal inspiration and maximal respiration against a valve (shutter) that closes the respiratory tract during expiration. The best of three measurements is accepted.

  4. 6-minute walk test (6MWT) [ Time Frame: 4 weeks ]
    Functional exercise capacity was assessed using the 6-minute walk test (6MWT). Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and pulse oximeter will measure O2 saturation, and according to Borg scale, dyspnea and fatigue level will be determined. Oxygen will be provided immediately following exercise for patients who desaturate (SpO2 <88%), or as needed.

  5. 6-minute pegboard and ring test (6PBRT) [ Time Frame: 4 weeks ]
    Subjects are asked to sit straight in a chair and a pegboard with multiple peg positions is placed in front of the subject at arm's length from the body. Two pegs are positioned at the shoulder level and 2 at 20 cm above the shoulder level, and 10 rings (1/2 oz per ring) are put on each of the 2 lower pegs. The final score is the total number of rings moved during the 6-minute period. Subjects are permitted to stop and rest during the test if they feel severe dyspnea, fatigue, or other discomfort, and continue moving the pegs as soon as they can. Subjects are asked to score the perceived dyspnea and fatigue after the test by the Borg scale. Each subject performe the PBRT twice. A pulse oximeter is used to monitor heart rate (HR) and arterial oxygen saturation (Sao2), and measure blood pressure (BP) before and after each test.


Secondary Outcome Measures :
  1. Timed Up and Go Test (TUG) [ Time Frame: 4 weeks ]
    TUG is a reliable and simple test to assess balance and functional mobility of stroke patients. The patient sited in chair and with command of physiotherapist raised from the chair, walked 3 meters, walked back to the chair and sited down again. The time of process was recorded by the physiotherapist in seconds. It was allowed to use walking aid during the test. Lower duration indicates better mobility performance.

  2. Sit to Stand Test (STS) [ Time Frame: 4 weeks ]
    It is a test based on crossing the patient's hands at the chest and making the most repetition possible by sitting and lifting continuously for 30 seconds. The number of sit down and stand up is recorded by the physiotherapist.

  3. Static Posturography System (TETRAX) [ Time Frame: 4 weeks ]
    Static posturography formed with four separate plates and each force plate measures the perpendicular pressure of the anterior and posterior feet. Subjects took off their shoes, positioned their feet on the plates, and stood in a comfortable position. Eight different postures were evaluated for the test and each posture was measured for 32 seconds. For the postural variable factors, the stability index (ST), Fourier index, weight distribution index (WDI), and the synchronization index (SI) are measured.

  4. Peripheral Muscle Strength Measurement [ Time Frame: 4 weeks ]
    Quadriceps femoris and biceps brachii isometric muscle strength will be measured by portable hand dynamometer (JTECH, Medical Commander Powertrack II, USA). Isometric muscle strength of Quadriceps femoris and biceps brachii is measured by portable hand dynamometer. Quadriceps femoris muscle force is measured in sitting position, at knee extension, and biceps brachii muscle strength at backrest position, while elbow is flexed. The measurements are repeated three times in succession and the average is recorded.

  5. The Fatigue Severity Scale (FSS) [ Time Frame: 4 weeks ]
    The Fatigue Severity Scale is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Respondents answer using a Likert scale ranging from 1 to 7. ''1'' indicates strong disagreement with the statement, while ''7'' indicates strong agreement. Total score is calculated by deriving an arithmetic mean. FSS scores range from 0-63. A score of 36 or higher generally indicates severe fatigue.

  6. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 4 weeks ]
    The SGRQ is a standardized self-administered airways disease-specific questionnaire. It contains 50 items (covering 76 levels) divided into three subscales: ''Symptoms'' (8 items), including several respiratory symptoms, their frequency and severity; ''Activity'' (16 items), concerned with activities that cause or are limited by breathlessness; and ''Impacts'' (26 items), which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. SGRQ scores range from 0-100, zero score indicating no impairment of life quality. Answers to SGRQ items are weighted and total SGRQ score and scores on the three subscales (Symptom frequency, Impact, and Activity) are calculated by adding these weights. Scores are then converted to percentages by dividing the weighted score obtained by the total possible weighted score. The higher the score the poorer the quality of life.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with interstitial lung disease (Idiopathic Pulmonary Fibrosis, pneumoconiosis, chronic hypersensitivity pneumonia, radiation fibrosis, collagenosis pulmonary involvement, nonspecific interstitial pneumonitis-NSIP, idiopathic NSIP)
  • Patients whose stability and medical treatment have not been changed for the last 3 months will be included in the study.

Exclusion Criteria:

  • Malignant tumor,
  • presence of co-morbidities that prevent exercise training (severe orthopedic or neurological deficit, unstable cardiac disease)
  • The knee and / or hip joint replacement operation has been performed,
  • having lower and upper limb amputation,
  • taking any hormone replacement or medication that may affect the normal metabolism of the musculoskeletal system,
  • presence of neurological (MS, intracranial tumor, neurodegenerative diseases, cerebrovascular event, epilepsy) disease which will affect balance and proprioception,
  • those with drug use history (antidepressants, anticonvulsants, sedatives, betahistine) that may affect the balance,
  • having Ischemic heart disease, dilate, hypertrophic or nonidiopathic cardiomyopathy,
  • having pacemaker entity, By-pass, coronary stent,
  • having uncontrolled DM,
  • presence of acute arthritis / tendinopathy,
  • O2 saturation in room air <80% (resting), patient with advanced respiratory failure,
  • having severe neurological and / or metabolic pathologies,
  • having hemodynamic instability,
  • Being pregnant and breastfeeding,
  • Individuals with a recent surgical operation, ILD, will not be included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560154


Locations
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Turkey
Nur Selin Of
Istanbul, Istanbul University/Cerrahpasa Faculty Of Medicine, Turkey, 34096
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Zerrin Yiğit, Prof Istanbul University/Institute of Cardiology

Publications:

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Responsible Party: Nur Selin Of, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03560154     History of Changes
Other Study ID Numbers: N-85
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nur Selin Of, Istanbul University:
Pulmonary Function Test
Peripheral Muscle strength
Postural balance
Dyspnea
Pulmonary Muscle Strength
Functional Capacity
Fatigue
Quality of Life

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Respiratory Tract Diseases