Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF)
3-IPF
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedJune 7, 2018
May 1, 2018
1.7 years
May 24, 2018
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the distance walked at a 6MWT measured at week 12
Change in the distance walked at a 6MWT measured at week 12
12 weeks
Secondary Outcomes (7)
Change in the distance walked at a 6MWT
measured 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline
Change in total score in health-related quality of life measured by SGRQ-IPF
at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.
Change in total score in health-related quality of life measured by KBILD
at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.
Change in total score of anxiety measured by GAD-7
at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.
Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ-IPF
at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.
- +2 more secondary outcomes
Study Arms (2)
Intervention group "tele-rehabilitation"
EXPERIMENTALEach patient will have the opportunity to have minimum one Video Consultation (VC) per week the first month, one VC each second week the second month one VC a month the rest of the trial. Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA. Instead of ergometer bike training, the patient will receive some easy training tools such as elastics, weights and a fitness-step that can be used in the different exercises showed by the VPA to reach the same intensity of workout. The VPA will then be animated to motivate and encourage the patient to exercises at home. A digital diary will automatically register the data obtained by the system on patient's performance.
Control
ACTIVE COMPARATORPatients will be followed, but they do not get any other kind of treatment comparable to the intervention group treatment.
Interventions
A Virtual Autonomous Physiotherapist Agent is going to gide and motivate the patient to train physically at home.
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, the patient must meet all of the following criteria:
- Diagnosis of either definite or possible IPF according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria Signed informed consent DLCO ≥ 30% predicted and FVC ≥ 50% predicted 6 minute walking test ≥ 150 m Adults ≥ 18 years Being clinically stable Absolute decline in DLCO \& FVC should be less than 10% in the past 6 months.
You may not qualify if:
- A potential patient who meets any of the following criteria will be excluded from participation in this study if:
- Participation in an official rehabilitation program \< 4 months before start of the study Musculoskeletal disorders Severe cardiac diseases (ejection fraction \< 30%, daily angina, or otherwise specified by treating cardiologist) Unable to understand informed consent Other conditions that hamper the use of tele-rehabilitation Non-Danish speaking. Unwillingness to implement the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Eurostarscollaborator
Study Sites (1)
Jose Cerdan
Aarhus, Danmark, 8000, Denmark
Related Publications (1)
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PMID: 33511633DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The study is a randomized controlled trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 7, 2018
Study Start
September 1, 2017
Primary Completion
May 30, 2019
Study Completion
January 31, 2020
Last Updated
June 7, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share