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Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF) (3-IPF)

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ClinicalTrials.gov Identifier: NCT03548181
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Eurostars
Information provided by (Responsible Party):
University of Aarhus

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


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a prospective, randomized controlled trial comparing the effects of tele-rehabilitation and standard treatment in patients with IPF
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The study is a randomized controlled trial
Primary Purpose: Treatment
Official Title: Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : January 31, 2020


Arm Intervention/treatment
Experimental: Intervention group "tele-rehabilitation"

Each 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.

Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA)
A Virtual Autonomous Physiotherapist Agent is going to gide and motivate the patient to train physically at home.
Other Name: VAPA

Active Comparator: Control
Patients will be followed, but they do not get any other kind of treatment comparable to the intervention group treatment.
Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA)
A Virtual Autonomous Physiotherapist Agent is going to gide and motivate the patient to train physically at home.
Other Name: VAPA




Primary Outcome Measures :
  1. Change in the distance walked at a 6MWT measured at week 12 [ Time Frame: 12 weeks ]
    Change in the distance walked at a 6MWT measured at week 12


Secondary Outcome Measures :
  1. Change in the distance walked at a 6MWT [ Time Frame: measured 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline ]
    Change in the distance walked at a 6MWT measured 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.

  2. Change in total score in health-related quality of life measured by SGRQ-IPF [ Time Frame: 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 SGRQ-IPF at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.

  3. Change in total score in health-related quality of life measured by KBILD [ Time Frame: 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.

  4. Change in total score of anxiety measured by GAD-7 [ Time Frame: 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.

  5. Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ-IPF [ Time Frame: 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.

  6. Change in the number of steps walked measured by a pedometer. [ Time Frame: at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline. ]
    Change in the number of steps walked measured by a pedometer.

  7. Cost of the tele-rehabilitation program [ Time Frame: At week 12 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548181


Contacts
Contact: Jose Cerdan, PhD student +4530648283 joscer@rm.dk
Contact: Elisabeth Bendstrup, Ph.D +45 7846 2201 karbends@rm.dk

Locations
Denmark
Jose Cerdan Recruiting
Aarhus, Danmark, Denmark, 8000
Contact: Jose Cerdan, PhD student    30648283    joscer@rm.dk   
Contact: Elisabeth Bendstrup, PhD, M.D    +45 7846 2201    karbends@rm.dk   
Sponsors and Collaborators
University of Aarhus
Eurostars

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03548181     History of Changes
Other Study ID Numbers: 3-TELE IPF
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Tele-rehabilitation

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial