Clinical trial NCT03560154: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Pulmonary Function Test
timeFrame: 4 weeks
measure: Diffusing capacity for carbon monoxide (DLCO)
timeFrame: 4 weeks
measure: Respiratory muscle strength
timeFrame: 4 weeks
measure: 6-minute walk test (6MWT)
timeFrame: 4 weeks
measure: 6-minute pegboard and ring test (6PBRT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: 4 weeks
measure: Sit to Stand Test (STS)
timeFrame: 4 weeks
measure: Static Posturography System (TETRAX)
timeFrame: 4 weeks
measure: Peripheral Muscle Strength Measurement
timeFrame: 4 weeks
measure: The Fatigue Severity Scale (FSS)
timeFrame: 4 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nur Selin Of
state: Istanbul University/Cerrahpasa Faculty Of Medicine
Study officials:
affiliation: Istanbul University/Institute of Cardiology
name: Zerrin Yiğit, Prof
role: STUDY_DIRECTOR
References:
citation: Salhi B, Malfait TJ, Van Maele G, Joos G, van Meerbeeck JP, Derom E. Effects of Whole Body Vibration in Patients With COPD. COPD. 2015;12(5):525-32. doi: 10.3109/15412555.2015.1008693. Epub 2015 Aug 4.
citation: 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.
citation: 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.
citation: Gloeckl R, Heinzelmann I, Kenn K. Whole body vibration training in patients with COPD: A systematic review. Chron Respir Dis. 2015 Aug;12(3):212-21. doi: 10.1177/1479972315583049. Epub 2015 Apr 22.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hanada M, Sakamoto N, Ishimatsu Y, Kakugawa T, Obase Y, Kozu R, Senjyu H, Izumikawa K, Mukae H, Kohno S. Effect of long-term treatment with corticosteroids on skeletal muscle strength, functional exercise capacity and health status in patients with interstitial lung disease. Respirology. 2016 Aug;21(6):1088-93. doi: 10.1111/resp.12807. Epub 2016 May 13.
citation: 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.
citation: Nishiyama O, Yamazaki R, Sano H, Iwanaga T, Higashimoto Y, Kume H, Tohda Y. Physical activity in daily life in patients with idiopathic pulmonary fibrosis. Respir Investig. 2018 Jan;56(1):57-63. doi: 10.1016/j.resinv.2017.09.004. Epub 2017 Oct 23.
citation: 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.
citation: 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.
citation: Wickerson L, Mathur S, Helm D, Singer L, Brooks D. Physical activity profile of lung transplant candidates with interstitial lung disease. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):106-12. doi: 10.1097/HCR.0b013e3182839293.
citation: Dale MT, McKeough ZJ, Munoz PA, Corte P, Bye PT, Alison JA. Physical activity in people with asbestos related pleural disease and dust-related interstitial lung disease: An observational study. Chron Respir Dis. 2015 Nov;12(4):291-8. doi: 10.1177/1479972315587518. Epub 2015 Jun 5.
citation: Dale MT, McKeough ZJ, Troosters T, Bye P, Alison JA. Exercise training to improve exercise capacity and quality of life in people with non-malignant dust-related respiratory diseases. Cochrane Database Syst Rev. 2015 Nov 5;2015(11):CD009385. doi: 10.1002/14651858.CD009385.pub2.
citation: Dowman L, McDonald CF, Hill C, Lee A, Barker K, Boote C, Glaspole I, Goh N, Southcott A, Burge A, Ndongo R, Martin A, Holland AE. The benefits of exercise training in interstitial lung disease: protocol for a multicentre randomised controlled trial. BMC Pulm Med. 2013 Feb 1;13:8. doi: 10.1186/1471-2466-13-8.
citation: Tonelli R, Cocconcelli E, Lanini B, Romagnoli I, Florini F, Castaniere I, Andrisani D, Cerri S, Luppi F, Fantini R, Marchioni A, Beghe B, Gigliotti F, Clini EM. Effectiveness of pulmonary rehabilitation in patients with interstitial lung disease of different etiology: a multicenter prospective study. BMC Pulm Med. 2017 Oct 10;17(1):130. doi: 10.1186/s12890-017-0476-5.
citation: Janaudis-Ferreira T. Exercise training improves exercise capacity and quality of life in people with interstitial lung disease [synopsis]. J Physiother. 2017 Oct;63(4):257. doi: 10.1016/j.jphys.2017.07.002. Epub 2017 Sep 6. No abstract available.
citation: Wickerson L. Exercise training improves exercise capacity and quality of life in people with interstitial lung disease [commentary]. J Physiother. 2017 Oct;63(4):257. doi: 10.1016/j.jphys.2017.07.001. Epub 2017 Sep 6. No abstract available.
citation: Keyser RE, Christensen EJ, Chin LM, Woolstenhulme JG, Drinkard B, Quinn A, Connors G, Weir NA, Nathan SD, Chan LE. Changes in fatigability following intense aerobic exercise training in patients with interstitial lung disease. Respir Med. 2015 Apr;109(4):517-25. doi: 10.1016/j.rmed.2015.01.021. Epub 2015 Feb 7.
citation: Caron M, Hoa S, Hudson M, Schwartzman K, Steele R. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease. Eur Respir Rev. 2018 May 15;27(148):170102. doi: 10.1183/16000617.0102-2017. Print 2018 Jun 30.
citation: Szentes BL, Kreuter M, Bahmer T, Birring SS, Claussen M, Waelscher J, Leidl R, Schwarzkopf L. Quality of life assessment in interstitial lung diseases:a comparison of the disease-specific K-BILD with the generic EQ-5D-5L. Respir Res. 2018 May 25;19(1):101. doi: 10.1186/s12931-018-0808-x.
citation: 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.
citation: Suzuki A, Kondoh Y, Swigris JJ, Ando M, Kimura T, Kataoka K, Yamano Y, Furukawa T, Numata M, Sakamoto K, Hasegawa Y. Performance of the St George's Respiratory Questionnaire in patients with connective tissue disease-associated interstitial lung disease. Respirology. 2018 Mar 25. doi: 10.1111/resp.13293. Online ahead of print.