Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients

Interstitial Lung Disease Clinical Trial

Official title:

Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946708
• Other study ID #: HS24936 (B2021:051)
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 17, 2022
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Exercise program (virtual/remote)
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.

Locations

Country	Name	City	State
Canada	U of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (23)

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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). pii: 1900281. doi: 10.1183/13993003.00281-2019. Print 2019 Sep. — View Citation

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Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung capacity	It will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ERS guidelines, connects automatically via Bluetooth to an iOS & Android compatible App (MIR Spirobank). It provides real time feedback through messages and animation on smartphone, to improve personal compliance during the test. The app can generate test results PDF printout with information regarding 19 parameters of lung capacity.	8 weeks
Primary	Change in dyspnea	Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.	8 weeks
Primary	Change in fatigue	Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.	8 weeks
Primary	Change in exercise capacity	Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).	8 weeks
Primary	Change in post-exercise saturation	SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test.	8 weeks
Primary	Change in physical function	Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).	8 weeks
Primary	Changes in health-related quality of life (HRQoL)	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).	8 weeks