NCT03548181: 3-IPF

Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF)

Status unknown Phase 2 Last updated 7 June 2018

What this trial tests

Phase 2 trial testing Virtual Autonomous Physiotherapist Agent (VAPA) in Idiopathic Pulmonary Fibrosis in 30 participants. Status unknown.

Timeline

1 September 2017

Primary endpoint
30 May 2019

31 January 2020

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 September 2017
Primary completion	30 May 2019
Estimated completion	31 January 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Virtual Autonomous Physiotherapist Agent (VAPA)

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

University of Aarhus

Who can join

Adults 18 to 85, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of unknown cause with a median survival of 3-5 years. As the disease progresses, worsening of lung function and gas exchange impairment cause hypoxemia during physical activity leading to a downward spiral; dyspnea and fatigue lead to a reduction in daily physical activities, exercise tolerance, muscle strength and quality of life. Problems reported by IPF patients are social isolation, increased level of dependency and immobility.

There is no curative treatment for IPF, but pulmonary rehabilitation (PR) is recommended by expert opinion for the majority of IPF patients in order to improve quality of life and exercise tolerance. There are, however, no official PR programs for IPF patients and they therefore either participate in PR programs patients with chronic obstructive lung diseases (COPD) or train by themselves in fitness centers without guidance. PR for COPD is mostly offered in specialized clinics with an average duration of 8 weeks. Not all patients with IPF are fit for these programs or want to participate in an extensive external program due to, among other reasons, distance to the clinic. Tele-rehabilitation may offer these patients an alternative.

New technologies in healthcare that can treat patients from a distance are implemented in these years. Tele-rehabilitation has been shown to be feasible in patients with lymphedema, COPD, orthopedic diseases (lower back, knee and shoulder). To ensure that all IPF patients are offered the possibility to participate in IPF specific rehabilitation programs, even though they live far away from expert ILD centers, tele-rehabilitation might be an alternative to participation in COPD rehabilitation programs. There have so far been no studies on the feasibility effect of tele-rehabilitation in IPF.

Aim To assess the feasibility and effect of tele-rehabilitation with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with IPF.

Method \& material The study is a prospective randomized controlled trial comparing the effects of tele-rehabilitation and standard treatment in patients with IPF. 24 patients with IPF will be randomized in two groups, and the intervention group trained by tele-rehabilitation for 12 weeks with follow-up after training at 3 and 6 months. The control group will follow the usual control program for IPF patients that only involves outpatient visits approximately every 3rd month. The intervention group will recieve tele-rehabilitation.in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.

Patients will be tested with pulmonary function parameters, 6 minute walk test, a pedometer registering steps walked in 7 days, King's brief ILD questionnaire (a disease specific quality of life questionnaire), the General Anxiety Disorder Score (GAD-7) (measures the presence and severity of general anxiety disorder) and the SGRQ-IPF, a disease specific, self-administered questionnaire for IPF, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Telerehabilitation for chronic respiratory disease.
   Cox NS, Dal Corso S, Hansen H, McDonald CF, et al · · 2021 · cited 280× · PMID 33511633 · DOI 10.1002/14651858.cd013040.pub2
2. Tele-Rehabilitation Program in Idiopathic Pulmonary Fibrosis-A Single-Center Randomized Trial.
   Cerdán-de-Las-Heras J, Balbino F, Løkke A, Catalán-Matamoros D, et al · · 2021 · cited 43× · PMID 34639313 · DOI 10.3390/ijerph181910016