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Trial record 95 of 683 for:    CARBON DIOXIDE AND arterial

Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045666
Recruitment Status : Unknown
Verified January 2017 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
University of Haifa
Information provided by (Responsible Party):
Soroka University Medical Center

Tracking Information
First Submitted Date  ICMJE February 5, 2017
First Posted Date  ICMJE February 7, 2017
Last Update Posted Date April 6, 2017
Estimated Study Start Date  ICMJE April 15, 2017
Estimated Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
Cardio-pulmonary exercise test- measurements of VO2 , anaerobic threshold, respiratory exchange ratio, O2 pulse, ventilatory reserve, heart rate, End tidal CO2 and O2, work rate, ventilation (VE), VCO2 during exercise test [ Time Frame: 0-24 weeks ]
Physiological response to exercise
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2017)
Cardio-pulmonary exercise test [ Time Frame: 0-24 weeks ]
Physiological response to exercise
Change History Complete list of historical versions of study NCT03045666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure [ Time Frame: 0-12 weeks ]
    Cardiac function
  • EMPHASIS10 questionnaire [ Time Frame: 0-24 weeks ]
    Disease specific quality of life questionnaire
  • SF-36 questionnaire [ Time Frame: 0-24 weeks ]
    Quality of life questionnaire
  • N-terminal prohormone brain natriuretic peptide (NT-proBNP) [ Time Frame: 0-12 weeks ]
    high levels of NT-proBNP can indicate heart failure
  • Functional class evaluation [ Time Frame: 0-24 weeks ]
    Functional class as classified by the world health organization (WHO)
  • 6 minute walk distance [ Time Frame: 0-24 weeks ]
    Functional capacity assesment by 6 minute walk test
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2017)
  • Echocardiography [ Time Frame: 0-12 weeks ]
    Cardiac function
  • EMPHASIS10 questionnaire [ Time Frame: 0-24 weeks ]
    Disease specific quality of life questionnaire
  • SF-36 questionnaire [ Time Frame: 0-24 weeks ]
    Quality of life questionnaire
  • N-terminal prohormone brain natriuretic peptide (NT-proBNP) [ Time Frame: 0-12 weeks ]
    high levels of NT-proBNP can indicate heart failure
  • Functional class evaluation [ Time Frame: 0-24 weeks ]
    Functional class as classified by the world health organization (WHO)
  • 6 minute walk test [ Time Frame: 0-24 weeks ]
    Functional capacity assesment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.
Official Title  ICMJE The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Other: Exercise program
patients who are stable on Macitentan therapy (received in both groups before enrollment) and will exercise at a pulmonary rehabilitation program twice a week for 12 weeks
Other Name: Rehabilitation program
Study Arms  ICMJE
  • Experimental: Intervention group
    Patients stable on Macitentan therapy will exercise twice a week for 12 weeks, supervised by physiotherapists. The exercise program includes aerobic and strength exercises, at 2-3 minutes intervals.
    Intervention: Other: Exercise program
  • No Intervention: Control Group
    Patients stable on Macitentan therapy that will continue to receive it, without exercise.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 5, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2018
Estimated Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. PAH patients group 1
  2. Patients Age > 18 years,
  3. Patients with WHO III
  4. Patients on Macitentan treatment who are stable on disease-targeted medication for at least 2 months prior to inclusion.

Exclusion Criteria:

  1. Patients with other significant comorbidity such as Pulmonary veno-occlusive disease (PVOD) or pulmonary capillary haemangiomatosis, Malignancy, Recent myocardial infarction in the last 2 weeks.
  2. Patients on other PAH specific medications treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03045666
Other Study ID Numbers  ICMJE SOR-026116-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Soroka University Medical Center
Study Sponsor  ICMJE Soroka University Medical Center
Collaborators  ICMJE University of Haifa
Investigators  ICMJE
Principal Investigator: Avital Abriel Keren Soroka University Medical Center
PRS Account Soroka University Medical Center
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP