Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03045666
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2017-02-05
Brief Title:
Impact of Rehabilitation Program on PAH Patients Treated With Macitentan
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
48 patients over the age of 18 with pulmonary arterial hypertension PAH classified as WHO III-IV that are all stable under Macitentan therapy medication for treating PAH patients will be recruited to the study through the pulmonary hypertension PH clinic at Soroka Medical Center The patients will be randomly divided into an intervention group which will exercise twice a week for 12 weeks supervised by physiotherapists and a control group which will only receive the medication Tests will be performed before the beginning of the intervention program 6 weeks after it has begun at the end of the 12 week program and 3 months after finishing the program
Detailed Description:
48 patients over the age of 18 with PAH classified as WHO III-IV that are all stable under Macitentan therapy will be recruited to the study through the PH clinic at Soroka Medical Center The patients will be randomly divided into intervention and control groups
The intervention group will exercise in a pulmonary rehabilitation program twice a week for 12 weeks The exercise protocol will include circuit training with 2-3 minutes exercise intervals including aerobic and strength training and will be supervised by physiotherapists The control group will continue to receive their usual Macitentan treatment
All study participants will undergo tests before the beginning of the intervention program 6 weeks after it has begun at the end of the 12 week program and 3 months after finishing the program The tests will include a cardio-pulmonary exercise test 6 minute walk distance measurement WHO functional class evaluation levels of Brain natriuretic peptide BNP EMPHASIS10 questionnaire emPHasis-10 questionnaire is a short questionnaire for assessing Health Related Quality of Life in pulmonary arterial hypertension Short Form-36 SF-36 quality of life questionnaire and echocardiography
Once data collection is completed two way ANOVA repeated measures will be used to assess the changes in outcome measures
The intervention group will exercise in a pulmonary rehabilitation program twice a week for 12 weeks The exercise protocol will include circuit training with 2-3 minutes exercise intervals including aerobic and strength training and will be supervised by physiotherapists The control group will continue to receive their usual Macitentan treatment
All study participants will undergo tests before the beginning of the intervention program 6 weeks after it has begun at the end of the 12 week program and 3 months after finishing the program The tests will include a cardio-pulmonary exercise test 6 minute walk distance measurement WHO functional class evaluation levels of Brain natriuretic peptide BNP EMPHASIS10 questionnaire emPHasis-10 questionnaire is a short questionnaire for assessing Health Related Quality of Life in pulmonary arterial hypertension Short Form-36 SF-36 quality of life questionnaire and echocardiography
Once data collection is completed two way ANOVA repeated measures will be used to assess the changes in outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None