Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis Pulmonary Sarcoidosis

NCT03914027 | Unknown DMC

• 1 other identifier: TeleSarco
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs. PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity. Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation. Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists. PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors. Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model. No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR 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, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.

Conditions

Sarcoidosis, Pulmonary; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 6MWT -12 weeks

  Change in the distance walked at a 6MWT measured at week 12.

  12 weeks afte baseline

Secondary Outcomes (9)

• 6MWT 6 and 9 month

  6 and 9 months after baseline.

• Change in muscle strength measured with the MVC

  12 weeks, 6 and 9 months after baseline

• Change in total score in health-related quality of life measured by Sct. Georges Respiratory Questionnaire (Jones, Quirk, and Baveystock 1991) (SGRQ)

  12 weeks, 6 and 9 months after baseline

• Change in fatigue measured by 10-item Fatigue Assessment Scale (FAS)

  12 weeks, 6 and 9 months after baseline

• Change in total score in health-related quality of life measured by The King's Brief Interstitial Lung disease health status questionnaire (KBILD)

  12 weeks, 6 and 9 months after baseline

Study Arms (2)

Control

NO INTERVENTION

Patients allocated to the control group will follow the same procedure except for not using tele-rehabilitation.

Intervention

EXPERIMENTAL

The intervention is the use of a tele-rehabilitation program during 12 weeks. The patient's training time will be registered automatically. The control group will receive standard treatment only.

Behavioral: Telerehabilitation

Interventions

Telerehabilitation BEHAVIORAL

Each patient will have the opportunity to have minimum one VC per week the first month, one Video Consultation each second week the second month one VC a month the rest of the trial. Here the physiotherapist, via history will extract the information needed to calibrate the daily TR program according to the patient's physical status and needs. 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.

Also known as: remote rehabilitation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PS
• Signed informed consent
• Adults ≥ 18 years
• DLCO ≥ 30% predicted and FVC ≥ 50% predicted
• minute walking test distance ≥ 150 m

You may not qualify if:

• Participation in an official rehabilitation program \< 3 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Eurostars: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Pulmonary Disease Research Center

Aarhus, Aarhus, 8000, Denmark

RECRUITING

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: 33511633 DERIVED

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sarcoidosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Elisabeth Bendstrup, PhD, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Cerdan, PhD stud

CONTACT

+4530648283; joscer@rm.dk

Elisabeth Bendstrup, PhD, MD

CONTACT

+45 7846 2201; karbends@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomisation will allocate patients to either the intervention or control group. This will be performed electronically by using a randomization plan generator ("Randomization Plans: Never the Same Thing Twice!" n.d.) that has already given a randomization plan and code to generate the same plan obtained. To reproduce this study randomization plan, enter at http://www.jerrydallal.com/random/permute.htm : 24 subjects randomized into 2 blocks (intervention, control) Seed number 10180. Block randomization will be used to ensure that the numbers of participants assigned to each group is equally distributed during the different seasons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Prospective randomized controlled trial. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR 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.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 12, 2019
• Study Start: December 12, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2025
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

DK (1)