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- Klinische proef NCT04946708
Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients
Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.
Design: this pilot-study uses a two-group random assignment pretest-posttest design. Once the groups are being selected an envelope will be mailed to the participant with the printed version of the exercise program and surveys, a portable SpiroBank Smart FN multi parameter spirometer (MIR), a finger pulse oximeter (LOOKEE), a diary, and a prepaid envelop for a subsequent post-intervention return of the equipment and surveys and the diary.
Intervention: A) Exercise program: evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed. B) Patients intake: in a zoom meeting, a registered therapist (Pl) in charge of implementing the intervention will request informed consent to participate in the study, explain specifics of the intervention to each participant, and will conduct an initial assessment. C) Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum Sp02), explain the educational materials, and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All participants (and immediate caregiver I necessary) will receive training: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy. Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The therapist will lead the first three meetings, gradually encourage participants to take turns leading the exercises with the goal of identifying /empowering potential patient leaders. Beginning with the fourth meeting, participants will be encouraged to connect to the meeting and follow their exercise program on their own, taking into account their individualized recommendations. The RA will organize and attend the zoom meetings to resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. D) Self-monitoring: patients will be asked to wear the finger pulse oximeter at all times while exercising, so that they can control their pace while avoiding exceeding target values (HR, Sp02). They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary. E) Support: participants will be able to contact the therapist at any time during the study if they have questions or concerns. Otherwise, they will receive a follow-up phone call once a week from the RA.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0T6
- U of Manitoba
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Clinical diagnosis of interstitial lung disease
- Access to a smart phone or tablet and home internet
Exclusion Criteria:
- Acute exacerbation of their ILDs condition
- History of neurological disease or mental illness
- Inability to ambulate independently without supervision
- Inability to complete basic tasks on a smart phone or tablet
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Zoombijeenkomst in kleine groep
Groep één: zal worden gevraagd om het oefenprogramma te volgen met een kleine groep leeftijdsgenoten (2 groepen/elk 6 deelnemers) in een zoombijeenkomst 3 keer per week/elk 45 min (inclusief 5 min voor en 10 min na de bijeenkomst gratis talk-chat tussen de deelnemers b.v.
vragen, percepties, enz.).
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Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g.
maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
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Experimenteel: YouTube vooraf opgenomen video
Groep twee: zal worden gevraagd om het oefenprogramma 3 keer per week/elk 30 min te volgen tijdens het bekijken van een vooraf opgenomen YouTube-video.
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Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g.
maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Verandering in longcapaciteit
Tijdsspanne: 8 weken
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Het zal worden beoordeeld met behulp van een SpiroBank Smart F/V multi-parameter spirometer (MIR) bij pre-post interventie en eenmaal per week tussendoor om veranderingen te controleren.
Deze draagbare spirometer, die MDSAP-goedgekeurd is en voldoet aan de ATS/ERS-richtlijnen, maakt automatisch via Bluetooth verbinding met een iOS- en Android-compatibele app (MIR Spirobank).
Het geeft real-time feedback via berichten en animaties op de smartphone, om de persoonlijke naleving tijdens de test te verbeteren.
De app kan een PDF-afdruk van testresultaten genereren met informatie over 19 parameters van de longcapaciteit.
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8 weken
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Verandering in vermoeidheid
Tijdsspanne: 8 weken
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De schaal van de ernst van vermoeidheid (0 -7 "hoger slechter") zal worden gebruikt om de ernst van vermoeidheid te meten.
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8 weken
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Verandering in inspanningscapaciteit
Tijdsspanne: 8 weken
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Beoordeeld met de zit-naar-sta-test van één minuut (aantal keren dat de personen de taak in één minuut kunnen voltooien).
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8 weken
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Verandering in verzadiging na inspanning
Tijdsspanne: 8 weken
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SpO2 wordt gemeten met een digitale vingertop-pulsoximeter voor en na de zit-naar-stand-test van één minuut.
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8 weken
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Change in dyspnea
Tijdsspanne: 8 weeks
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Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.
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8 weeks
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Change in physical function
Tijdsspanne: 8 weeks
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Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).
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8 weeks
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Changes in health-related quality of life (HRQoL)
Tijdsspanne: 8 weeks
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Assessed with the King's Brief Interstitial Lung Disease (KBILD), which is an ILD-specific measure of HRQoL.
Total score ranges are 0-100 (100 represents best HRQoL).
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8 weeks
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
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- Dowman LM, McDonald CF, Hill CJ, Lee AL, Barker K, Boote C, Glaspole I, Goh NSL, Southcott AM, Burge AT, Gillies R, Martin A, Holland AE. The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial. Thorax. 2017 Jul;72(7):610-619. doi: 10.1136/thoraxjnl-2016-208638. Epub 2017 Feb 17.
- 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.
- Travis WD, Costabel U, Hansell DM, King TE Jr, Lynch DA, Nicholson AG, Ryerson CJ, Ryu JH, Selman M, Wells AU, Behr J, Bouros D, Brown KK, Colby TV, Collard HR, Cordeiro CR, Cottin V, Crestani B, Drent M, Dudden RF, Egan J, Flaherty K, Hogaboam C, Inoue Y, Johkoh T, Kim DS, Kitaichi M, Loyd J, Martinez FJ, Myers J, Protzko S, Raghu G, Richeldi L, Sverzellati N, Swigris J, Valeyre D; ATS/ERS Committee on Idiopathic Interstitial Pneumonias. An official American Thoracic Society/European Respiratory Society statement: Update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med. 2013 Sep 15;188(6):733-48. doi: 10.1164/rccm.201308-1483ST.
- Ryerson CJ, Tan B, Fell CD, Manganas H, Shapera S, Mittoo S, Sadatsafavi M, To T, Gershon A, Fisher JH, Johannson KA, Hambly N, Khalil N, Marras TK, Morisset J, Wilcox PG, Halayko AJ, Khan MA, Kolb M. The Canadian Registry for Pulmonary Fibrosis: Design and Rationale of a National Pulmonary Fibrosis Registry. Can Respir J. 2016;2016:3562923. doi: 10.1155/2016/3562923. Epub 2016 Apr 5.
- Hopkins RB, Burke N, Fell C, Dion G, Kolb M. Epidemiology and survival of idiopathic pulmonary fibrosis from national data in Canada. Eur Respir J. 2016 Jul;48(1):187-95. doi: 10.1183/13993003.01504-2015. Epub 2016 May 26.
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- Florian J, Watte G, Teixeira PJZ, Altmayer S, Schio SM, Sanchez LB, Nascimento DZ, Camargo SM, Perin FA, Camargo JJ, Felicetti JC, Moreira JDS. Pulmonary rehabilitation improves survival in patients with idiopathic pulmonary fibrosis undergoing lung transplantation. Sci Rep. 2019 Jun 27;9(1):9347. doi: 10.1038/s41598-019-45828-2.
- Hanada M, Kasawara KT, Mathur S, Rozenberg D, Kozu R, Hassan SA, Reid WD. Aerobic and breathing exercises improve dyspnea, exercise capacity and quality of life in idiopathic pulmonary fibrosis patients: systematic review and meta-analysis. J Thorac Dis. 2020 Mar;12(3):1041-1055. doi: 10.21037/jtd.2019.12.27.
- Keating A, Lee A, Holland AE. What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chron Respir Dis. 2011;8(2):89-99. doi: 10.1177/1479972310393756.
- Nici L, Singh SJ, Holland AE, ZuWallack RL. Opportunities and Challenges in Expanding Pulmonary Rehabilitation into the Home and Community. Am J Respir Crit Care Med. 2019 Oct 1;200(7):822-827. doi: 10.1164/rccm.201903-0548PP. No abstract available.
- Spitzer KA, Stefan MS, Priya A, Pack QR, Pekow PS, Lagu T, Pinto-Plata VM, ZuWallack RL, Lindenauer PK. Participation in Pulmonary Rehabilitation after Hospitalization for Chronic Obstructive Pulmonary Disease among Medicare Beneficiaries. Ann Am Thorac Soc. 2019 Jan;16(1):99-106. doi: 10.1513/AnnalsATS.201805-332OC.
- Ozalevli S, Karaali HK, Ilgin D, Ucan ES. Effect of home-based pulmonary rehabilitation in patients with idiopathic pulmonary fibrosis. Multidiscip Respir Med. 2010 Feb 28;5(1):31-7. doi: 10.1186/2049-6958-5-1-31.
- Rammaert B, Leroy S, Cavestri B, Wallaert B, Grosbois JM. Home-based pulmonary rehabilitation in idiopathic pulmonary fibrosis. Rev Mal Respir. 2011 Sep;28(7):e52-7. doi: 10.1016/j.rmr.2011.06.006. Epub 2011 Jul 30.
- Chung BPH, Chiang WKH, Lau H, Lau TFO, Lai CWK, Sit CSY, Chan KY, Yeung CY, Lo TM, Hui E, Lee JSW. Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. Hong Kong Physiother J. 2020 Jun;40(1):63-73. doi: 10.1142/S1013702520500079. Epub 2020 Feb 20.
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- Briand J, Behal H, Chenivesse C, Wemeau-Stervinou L, Wallaert B. The 1-minute sit-to-stand test to detect exercise-induced oxygen desaturation in patients with interstitial lung disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618793028. doi: 10.1177/1753466618793028.
- Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
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- Nolan CM, Birring SS, Maddocks M, Maher TM, Patel S, Barker RE, Jones SE, Walsh JA, Wynne SC, George PM, Man WD. King's Brief Interstitial Lung Disease questionnaire: responsiveness and minimum clinically important difference. Eur Respir J. 2019 Sep 5;54(3):1900281. doi: 10.1183/13993003.00281-2019. Print 2019 Sep.
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HS24936 (B2021:051)
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Klinische onderzoeken op Exercise program (virtual/remote)
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