Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD

Summary

The purpose of this pilot randomized clinical trial is to evaluate the willingness, acceptance, adherence and signs of benefits of structured home-based pulmonary rehabilitation (HPR) and supervised pulmonary tele-rehabilitation (PTR) on respiratory symptoms, quality of life, functioning and physical activity in patients with ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis), Bronchiectasis and Asthma who have a clinically assessed need for a pulmonary rehabilitation program.

The main questions the project aims to answer are:

* Will HPR and PTR appeal to a minimum of 30% of the eligble patients
* Be greatly accepted (≥70% of participant complete 70% or more of the planned sessions) by patients agreeing to participate in the study
* Will PTR and HPR lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care

Researchers will compare with a comparable control group who gets usual care (scheduled controls and medication but no exercise intervention) to examine the willingness to be randomized and to get an indication on possible health related effects. Participants will be randomly assigned to one of three groups:

1. A structured supervised group-based PTR (exercise twice a week; each session consists of 35 min. evidence-based exercises and 25 min. of patient education)
2. An individual HPR program (self-initiated physical activity) with motivational and professional counseling once a week (10-15min), supported by a tablet screen
3. A control group receiving usual care (CON)

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)
• Sarcoidosis
• Bronchiectasis
• Asthma Bronchiale
• Interstitial Lung Diseases (ILD)

Interventions

BEHAVIORAL

pulmonary tele-rehabilitation (PTR)

PTR is delivered from promoter hospital to a group of 3 - 5 patients who exercise at home and communicate via tablet-camera. Each session is 60 min; 35 min exercise/ 25 min patient education, two times per week for a duration of 10-weeks. Specific exercises are evidence-based; been used in several intervention studies on patients with CRD (eg. COPD). Exercises involves larger muscle groups with 50/50 exercises for upper and lower extremities. Volume, intensity and content exercise protocol follow both national and international exercise recommendations. The education sessions consist of dialogue, reflections around empowerment and better living with CRD. Every sixth education session consists of 25 min Mindfulness exercises developed for CRD patients. After 10-weeks of PTR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period

BEHAVIORAL

Home-based pulmonary rehabilitation (HPR)

HPR is an individual self-initiated home-based PR aiming to achieve 20 min of self-initiated muscle endurance based exercise; 3-days/weekly for 10-weeks. Exercises are evidence based; used in several intervention studies on patients with CRD (eg. COPD) and involves larger muscle groups with 50/50 exercises for upper/lower extremities. First session is a home visit by a respiratory physiotherapist. During the visit the physiotherapist and patient establish exercise goals, exercise prescription and provision of access to mindfulness exercises and an educationbook. The home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to CRD and self-management is discussed. A session is delivered from promoter hospital via tablet-camera or telephone call (patients preference). After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period

BEHAVIORAL

Control

Receive usual care; medication, scheduled follow up visit and possible phone contact with GP and the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered. If a patient changes their decision and wishes to participate in a conventional hospital- or community-based PR program, it will be granted as this is a highly recommended treatment (e.g. rehabilitation after hospital admitted exacerbation).

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Nordsjaellands Hospital

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  lead OTHER

Principal Investigators

• Henrik Hansen, PhD, Msc, PT · Dept. of Respiratory Medicine, University Hospital Hvidovre

• Nina Godtfredsen, MD, PhD · Dept. of Respiratory Medicine, University Hospital Hvidovre

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2025-09-30

Completion

2027-05-31

Countries

• Denmark

Study Locations