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

Primary Purpose

Interstitial Lung Disease, Scleroderma, Idiopathic Pulmonary Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Whole Body Vibration Training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Pulmonary Function Test, Peripheral Muscle strength, Postural balance, Dyspnea, Pulmonary Muscle Strength, Functional Capacity, Fatigue, Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nur Selin Of

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole Body Vibration Training

Home respiratory exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pulmonary Function Test
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.
Diffusing capacity for carbon monoxide (DLCO)
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.
Respiratory muscle strength
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.
6-minute walk test (6MWT)
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.
6-minute pegboard and ring test (6PBRT)
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

Timed Up and Go Test (TUG)
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.
Sit to Stand Test (STS)
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.
Static Posturography System (TETRAX)
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.
Peripheral Muscle Strength Measurement
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.
The Fatigue Severity Scale (FSS)
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.
St. George's Respiratory Questionnaire (SGRQ)
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.

Full Information

First Posted
June 6, 2018
Last Updated
July 28, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03560154
Brief Title
Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease
Official Title
Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 when applied as an isolated intervention, home respiratory exercises programme may lead to lower results than combination programs.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Scleroderma, Idiopathic Pulmonary Fibrosis
Keywords
Pulmonary Function Test, Peripheral Muscle strength, Postural balance, Dyspnea, Pulmonary Muscle Strength, Functional Capacity, Fatigue, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Body Vibration Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Home respiratory exercises
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Whole Body Vibration Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Function Test
Description
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.
Time Frame
4 weeks
Title
Diffusing capacity for carbon monoxide (DLCO)
Description
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.
Time Frame
4 weeks
Title
Respiratory muscle strength
Description
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.
Time Frame
4 weeks
Title
6-minute walk test (6MWT)
Description
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.
Time Frame
4 weeks
Title
6-minute pegboard and ring test (6PBRT)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
4 weeks
Title
Sit to Stand Test (STS)
Description
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.
Time Frame
4 weeks
Title
Static Posturography System (TETRAX)
Description
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.
Time Frame
4 weeks
Title
Peripheral Muscle Strength Measurement
Description
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.
Time Frame
4 weeks
Title
The Fatigue Severity Scale (FSS)
Description
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.
Time Frame
4 weeks
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zerrin Yiğit, Prof
Organizational Affiliation
Istanbul University/Institute of Cardiology
Official's Role
Study Director
Facility Information:
Facility Name
Nur Selin Of
City
Istanbul
State/Province
Istanbul University/Cerrahpasa Faculty Of Medicine
ZIP/Postal Code
34096
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease

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