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

Expanding Pulmonary Rehabilitation in Other Chronic Respiratory Disease Than COPD - the ExPuRe Pilot Study

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Bronchiectasis; Sarcoidosis; Idiopathic Pulmonary Fibrosis (IPF); Asthma Bronchiale; Interstitial Lung Diseases (ILD)
• Intervention / Treatment: Behavioral: pulmonary tele-rehabilitation (PTR); Behavioral: Home-based pulmonary rehabilitation (HPR); Behavioral: Control

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).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Greater Copenhagen
    • Copenhagen, Greater Copenhagen, Denmark, 2300
      • Copenhagen University Center, Amager
    • Copenhagen, Greater Copenhagen, Denmark, 2400
      • Copenhagen University Center, Frederiksberg-Bispebjerg
    • Copenhagen, Greater Copenhagen, Denmark, 2650
      • Copenhagen University Center, Hvidovre
    • Gentofte Municipality, Greater Copenhagen, Denmark, 2820
      • Copenhagen University Center, Herlev-Gentofte
    • Hillerød, Greater Copenhagen, Denmark, 3400
      • Copenhagen University Center, Hillerød

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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; 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).
Experimental: pulmonary tele-rehabilitation (PTR); 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); 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
Experimental: Home-based pulmonary rehabilitation (HPR); 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test (CAT) / Chronic Airways Assessment Test (CAAT)	A patient self administered questionaire. An 8-item questionnaire designed to assess the impact of disease on a person's life (health status). Range of CAT scores from 0-40. Higher scores implicates a more severe impact of COPD on a patient's life(total score point) . respiratory symptoms BE (CAT) respiratory symptoms Asthma (CAAT)	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Asthma Control Questionnaire (ACQ-7)	A 7-item asthma specific questionaire to measure the adequacy of asthma control and change in asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled). The ACQ score is calculated as the average of 5, 6 or 7 items (total score point) . Only for those with Asthma	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Kings Brief Interstitial Lung Disease	The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status. (total score point) - only for those with ILD	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
EuroQol-5D-3L (EQ-5D-3L)	Patient completed questionaires that assess quality of life. Total score from 0-1 on EQ5D- health domain. Total score from 0 - 100 mm on EQ5D-VAS domain. No total domain score.	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Multidimensional Fatigue Inventory (MFI-20)	A patient completed questionaire with a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Items are scored 1-5. In the final score, high scores represent more fatigue (total score point)	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Pittsburg Sleep Quality Index (PSQI)	A self-rated 19-item questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality (total score point).	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
ActivePAL triaxial accelerometer (PAL) / SENS motion (PAL) (≥50% of total sample	Wearing time is 24 h per day for 5 days at each time point. Measures sedentary and active body movements, steps per day and METs. High number of activity is better	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
1-minute sit to stand (1-min-STS)	A clinical test where the patient performes as many sit to stand actions as possible in one minute. Measures endurance by counting the number of repetitions.	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
30-second sit to stand (30-sec-STS)	A clinical test where the patient performes as many sit to stand actions as possible in 30 seconds. Measures leg muscle strength by counting the number of repetitions.	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hand-grip strength (Jamar dynamometer)	Measure hangrip muscle strengt in kilo. The higher the better	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Number of hospital admissions (respiratory related and all-cause)	Report of the total number	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Mortality (respiratory related and all-cause)	Report of the total number	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Adverse events	Report of the numbers of severe adverse events and adverse events	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Brief Pain Inventory (BPI)	A nine item self-administered questionnaire used to evaluate the severity of a patients pain and the impact of this pain on the patients daily functioning. The Every symptom are rated on severity scale ranging from 0 - 10 (total score point).	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Short Physical Performance Battery and (SPPB)	An objective measurement instrument combining three test in one score. The tests consist of a balance test (measured in seconds), lower extremity strength (measured in seconds), and a walkning test measuring functional capacity (measured in seconds) in older adults (65 years of age). Score measured in seconds	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Hospital Anxiety and Depression Scale (HADS)	Patient self administered questionaires that assess anxiety and depression symptoms. Seven item domain questions for depression with a total score form of 0 - 21 points. Seven item domain questions for anxiety with total score from 0 - 21 points (total score point) .	Baseline; At 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: Copenhagen University Hospital at Herlev; University Hospital Bispebjerg and Frederiksberg; Nordsjaellands Hospital
• Investigators: Principal Investigator: Henrik Hansen, PhD, Msc, PT, Dept. of Respiratory Medicine, University Hospital Hvidovre; Study Chair: Nina Godtfredsen, MD, PhD, Dept. of Respiratory Medicine, University Hospital Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; home-based pulmonary rehabilitation; Pilot RCT Study; pulmonary tele-rehabilitation
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Pulmonary Fibrosis; Hemic and Lymphatic Diseases; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Sarcoidosis; Bronchiectasis
• Other Study ID Numbers: Add-on 96052 to H-22015777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access demands a part application to; (1) Danish Data Protection agency, (2) ethics committee of the capital region, (3) national health Data authorities. Only if the applications are approved data will be considered available for sharing. The investigator will not be able to support this process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No