Clinical trial NCT06636487: Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD
Official title: Expanding Pulmonary Rehabilitation in Other Chronic Respiratory Disease Than COPD - the ExPuRe Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Sarcoidosis
Bronchiectasis
Asthma Bronchiale
Interstitial Lung Diseases (ILD)
Keywords: Pilot RCT Study
Telerehabilitation
home-based pulmonary rehabilitation
pulmonary tele-rehabilitation
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
name: Copenhagen University Hospital, Herlev-Gentofte
name: Copenhagen University Hospital, Amager-Hvidovre, Denmark
name: Nordsjaellands Hospital
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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)

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Eligibility
timeFrame: Assesment before enrollment
measure: Adherence
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Acceptability
timeFrame: Acceptance when enrolling the project
Secondary outcomes:
measure: COPD Assessment Test (CAT) / Chronic Airways Assessment Test (CAAT)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Asthma Control Questionnaire (ACQ-7)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Kings Brief Interstitial Lung Disease
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: EuroQol-5D-3L (EQ-5D-3L)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: ActivePAL triaxial accelerometer (PAL) / SENS motion (PAL) (≥50% of total sample
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: 1-minute sit to stand (1-min-STS)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: 30-second sit to stand (30-sec-STS)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Hand-grip strength (Jamar dynamometer)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Number of hospital admissions (respiratory related and all-cause)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Mortality (respiratory related and all-cause)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Adverse events
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Short Physical Performance Battery and (SPPB)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Center, Amager
state: Greater Copenhagen
city: Copenhagen
country: Denmark
facility: Copenhagen University Center, Frederiksberg-Bispebjerg
state: Greater Copenhagen
city: Copenhagen
country: Denmark
facility: Copenhagen University Center, Hvidovre
state: Greater Copenhagen
city: Gentofte
country: Denmark
facility: Copenhagen University Center, Herlev-Gentofte
state: Greater Copenhagen
city: Hillerød
country: Denmark
facility: Copenhagen University Center, Hillerød
state: Greater Copenhagen
Study officials:
affiliation: Dept. of Respiratory Medicine, University Hospital Hvidovre
name: Henrik Hansen, PhD, Msc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Respiratory Medicine, University Hospital Hvidovre
name: Nina Godtfredsen, MD, PhD
role: STUDY_CHAIR
References: