Effects of Whole Body Vibration Training in Patients With Interstitial Lung Disease
NCT ID: NCT03560154
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-01-31
2020-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients whose stability and medical treatment have not been changed for the last 3 months will be included in the study.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Nur Selin Of
Principal Investigator
Principal Investigators
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Zerrin Yiğit, Prof
Role: STUDY_DIRECTOR
Istanbul University/Institute of Cardiology
Locations
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Nur Selin Of
Istanbul, Istanbul University/Cerrahpasa Faculty of Medicine, Turkey (Türkiye)
Countries
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References
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Turner S, Torode M, Climstein M, Naughton G, Greene D, Baker MK, Fiatarone Singh MA. A randomized controlled trial of whole body vibration exposure on markers of bone turnover in postmenopausal women. J Osteoporos. 2011;2011:710387. doi: 10.4061/2011/710387. Epub 2011 Jun 27.
Gloeckl R, Jarosch I, Bengsch U, Claus M, Schneeberger T, Andrianopoulos V, Christle JW, Hitzl W, Kenn K. What's the secret behind the benefits of whole-body vibration training in patients with COPD? A randomized, controlled trial. Respir Med. 2017 May;126:17-24. doi: 10.1016/j.rmed.2017.03.014. Epub 2017 Mar 14.
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Cardim AB, Marinho PE, Nascimento JF Jr, Fuzari HK, Dornelas de Andrade A. Does Whole-Body Vibration Improve the Functional Exercise Capacity of Subjects With COPD? A Meta-Analysis. Respir Care. 2016 Nov;61(11):1552-1559. doi: 10.4187/respcare.04763. Epub 2016 Sep 20.
Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
Deniz S, Sahin H, Yalniz E. Does the severity of interstitial lung disease affect the gains from pulmonary rehabilitation? Clin Respir J. 2018 Jun;12(6):2141-2150. doi: 10.1111/crj.12785. Epub 2018 Mar 24.
Dowman L, Hill CJ, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2014 Oct 6;(10):CD006322. doi: 10.1002/14651858.CD006322.pub3.
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Schaeffer MR, Ryerson CJ, Ramsook AH, Molgat-Seon Y, Wilkie SS, Dhillon SS, Mitchell RA, Sheel AW, Khalil N, Camp PG, Guenette JA. Neurophysiological mechanisms of exertional dyspnoea in fibrotic interstitial lung disease. Eur Respir J. 2018 Jan 18;51(1):1701726. doi: 10.1183/13993003.01726-2017. Print 2018 Jan.
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Yilmaz Yelvar GD, Cirak Y, Dalkilinc M, Demir YP, Baltaci G, Komurcu M. Impairments of postural stability, core endurance, fall index and functional mobility skills in patients with patello femoral pain syndrome. J Back Musculoskelet Rehabil. 2017;30(1):163-170. doi: 10.3233/BMR-160729.
Akkaya N, Doganlar N, Celik E, Aysse SE, Akkaya S, Gungor HR, Sahin F. TEST-RETEST RELIABILITY OF TETRAX(R) STATIC POSTUROGRAPHY SYSTEM IN YOUNG ADULTS WITH LOW PHYSICAL ACTIVITY LEVEL. Int J Sports Phys Ther. 2015 Nov;10(6):893-900.
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Ramadurai D, Riordan M, Graney B, Churney T, Olson AL, Swigris JJ. The impact of carrying supplemental oxygen on exercise capacity and dyspnea in patients with interstitial lung disease. Respir Med. 2018 May;138:32-37. doi: 10.1016/j.rmed.2018.03.025. Epub 2018 Mar 26.
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Other Identifiers
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N-85
Identifier Type: -
Identifier Source: org_study_id
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