Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD

NCT06636487 | Active Not Recruiting

• 1 other identifier: Add-on 96052 to H-22015777
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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:
• 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)
• An individual HPR program (self-initiated physical activity) with motivational and professional counseling once a week (10-15min), supported by a tablet screen
• A control group receiving usual care (CON)

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

Outcome Measures

Primary Outcomes (3)

• Eligibility

  Number of eligible patients for randomisation (Absolute number)

  Assesment before enrollment

• Adherence

  Number of participants adherent (Participant completion of 70% or more of the planned sessions) (Absolute number)

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

• Acceptability

  Number of patients accepting to participate (Absolute number)

  Acceptance when enrolling the project

Secondary Outcomes (16)

• COPD Assessment Test (CAT) / Chronic Airways Assessment Test (CAAT)

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

• Asthma Control Questionnaire (ACQ-7)

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

• Kings Brief Interstitial Lung Disease

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

• EuroQol-5D-3L (EQ-5D-3L)

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

• Multidimensional Fatigue Inventory (MFI-20)

  Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

Study Arms (3)

pulmonary tele-rehabilitation (PTR)

EXPERIMENTAL

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

Behavioral: pulmonary tele-rehabilitation (PTR)

Home-based pulmonary rehabilitation (HPR)

EXPERIMENTAL

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.

Behavioral: Home-based pulmonary rehabilitation (HPR)

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

pulmonary tele-rehabilitation (PTR) BEHAVIORAL

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

pulmonary tele-rehabilitation (PTR)

Home-based pulmonary rehabilitation (HPR) BEHAVIORAL

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

Home-based pulmonary rehabilitation (HPR)

Control BEHAVIORAL

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).

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Center-based PR is not standard available or
• 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:
• 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
• 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
• Bronchiectasis:
• FEV1 lower than 80%, HRCT verified, Age higher than 40 years, Confirmed respiratory physician diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Nordsjaellands Hospital: collaborator

Study Sites (5)

Copenhagen University Center, Amager

Copenhagen, Greater Copenhagen, 2300, Denmark

Location

Copenhagen University Center, Frederiksberg-Bispebjerg

Copenhagen, Greater Copenhagen, 2400, Denmark

Location

Copenhagen University Center, Hvidovre

Copenhagen, Greater Copenhagen, 2650, Denmark

Location

Copenhagen University Center, Herlev-Gentofte

Gentofte Municipality, Greater Copenhagen, 2820, Denmark

Location

Copenhagen University Center, Hillerød

Hillerød, Greater Copenhagen, 3400, Denmark

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Sarcoidosis; Bronchiectasis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Bronchial Diseases

Study Officials

• Henrik Hansen, PhD, Msc, PT

  Dept. of Respiratory Medicine, University Hospital Hvidovre

  PRINCIPAL INVESTIGATOR

• Nina Godtfredsen, MD, PhD

  Dept. of Respiratory Medicine, University Hospital Hvidovre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on predetermined outcomes, but not the specific nature of the models of interest, and the predetermined hypothesis about the purpose, acceptability, willingness and adherence to intervention group allocated. All assessors are blinded to group allocation and previous test results. In case of failure keeping the outcome assessor blinded (that is, if a participant reveals his/her allocation) a second assessor will be available to step in and conduct the assessment on another day. To avoid investigators (subconscious) bias the biostatistician who perform the data analyses and validate the results is blinded to group allocation. The research group will interpret the results, before the allocation code is broken.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, PhD

Model Details: A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)