Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636487
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Expand Pulmonary Rehabilitation to Other Chronic Respiratory Diseases Than COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanding Pulmonary Rehabilitation in Other Chronic Respiratory Disease Than COPD - the ExPuRe Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExPuRe
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None