Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD (ExPuRe)

Copenhagen University Hospital, Hvidovre

Status: Enrolling

Conditions: Sarcoidosis; Bronchiectasis; Idiopathic Pulmonary Fibrosis (IPF); Interstitial Lung Diseases (ILD); Asthma Bronchiale

Treatments: Behavioral: Control; Behavioral: Home-based pulmonary rehabilitation (HPR); Behavioral: pulmonary tele-rehabilitation (PTR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06636487

Add-on 96052 to H-22015777

Details and patient eligibility

About

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)

Full description

Primary objective of the ExPuRe study 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, Asthma and BE, who have a clinically assessed need for a pulmonary rehabilitation program.

The hypotheses are that HPR and PTR will appeal to 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, and that PTR and HPR will lead to positive changes in respiratory symptom relief, symptom relief in general and improve or maintain physical functioning larger than usual care, that is the control group (CON - no intervention).

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Residency in the Capital Region of Copenhagen

• A clinically assessed need for pulmonary rehabilitation including respiratory symptoms, corresponding to MRC grade 2 or higher and where:

  1. Center-based PR is not standard available or
  2. Center-based PR being declined by the patient

• Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid)

• Capable of lifting both arms to horizontal with at least 1 kg dumbbells in each hand

• And a minimum of one of the below mentioned diagnoses:

  1. ILD (Interstitial lung disease, Idiopathic pulmonary fibrosis, Sarcoidosis):

     DLCO lower than 80 % or FVC lower than 80%, HRCT verified, Age higher than 40 years, Confirmed respiratory physician diagnosis

  2. Asthma:

     With chronic airway obstruction, ACQ score higher than 1, FEV1 lower than 80%, Age higher than 50 years, Confirmed respiratory physician diagnosis of Asthma

  3. Bronchiectasis:

FEV1 lower than 80%, HRCT verified, Age higher than 40 years, Confirmed respiratory physician diagnosis

Exclusion criteria

• Cognitive impairment - unable to follow instructions
• Impaired hearing or vision - unable to see or hear instruction from a tablet
• Unable to understand and speak Danish
• Comorbidities where the exercise content is contraindicated

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

pulmonary tele-rehabilitation (PTR)

Experimental group

Description:

Recieve supervised PTR 2/weekly, session duration of 60 min; 35 min of exercise and 25 min of patient education for 10-weeks. Delivered from Hvidovre/Bispebjerg Hospital to groups of 3 - 5 patients who exercise at home and communicate via tablet-camera. After 10-weeks of PTR, participants are offered once weekly PTR for 60 minutes in groups of 4-8 patients throughout a 65-week maintenance period

Treatment:

Behavioral: pulmonary tele-rehabilitation (PTR)

Home-based pulmonary rehabilitation (HPR)

Experimental group

Description:

HPR is an individual self-initiated home-based PR program. Patient goal is to achieve at least 20 min of self-initiated muscle-endurance based exercise 3 days/ weekly for 10-weeks The first session is a home visit by an experienced respiratory physiotherapist and with focus on establishment of exercise goals, formal exercise prescription and education. The home visit is followed by 1/weekly session for 10-weeks.The sessions is delivered from Hvidovre/ Bispebjerg Hospital via tablet-camera or telephone call. After 10-weeks of HPR, participants are offered once weekly PTR for 60 min in groups of 4-8 patients throughout a 65-week maintenance period.

Treatment:

Behavioral: Home-based pulmonary rehabilitation (HPR)

Control

Active Comparator group

Description:

Control group will receive usual care; medication, scheduled follow-up visit and possible phone contact with GP or the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.

Treatment:

Behavioral: Control