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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen University Center, Amager
RECRUITING
Copenhagen
Copenhagen University Center, Frederiksberg-Bispebjerg
RECRUITING
Copenhagen
Copenhagen University Center, Hvidovre
RECRUITING
Copenhagen
Copenhagen University Center, Herlev-Gentofte
RECRUITING
Gentofte Municipality
Copenhagen University Center, Hillerød
RECRUITING
Hillerød
Contact Information
Primary
Henrik Hansen, PhD, PT
henrik.hansen.09@regionh.dk
4528946780
Backup
Maria Olsen, Msc, PT
maria.olsen.05@regionh.dk
4540740460
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 50
Treatments
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
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.
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.
Sponsors
Leads: Copenhagen University Hospital, Hvidovre
Collaborators: University Hospital Bispebjerg and Frederiksberg, Nordsjaellands Hospital, Copenhagen University Hospital, Amager-Hvidovre, Denmark, Copenhagen University Hospital at Herlev

This content was sourced from clinicaltrials.gov