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Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients

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: NCT03424863
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE February 22, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Peak systolic pressure during a single lower extremity muscle strengthening exercise [ Time Frame: 5 minutes: 15 repetitions of leg press muscle strength exercise. ]
Blood pressure is measured continuously using a finger clamp measurement device (Nexfin)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03424863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients
Official Title  ICMJE Peak Systolic Blood Pressure in Heart Patients With Aortic Stent-graft During Moderate Intensity Strength Training: A Descriptive Intervention Study
Brief Summary

Patients with an aortic stent graft are recommended to do muscle strengthening exercise as part of their rehabilitation. But, as excess blood pressure pose a risk to the integrity of the stent graft, high intensity muscle strengthening exercise may potentially be detrimental, and hence moderate intensity muscle strengthening is recommended. However, the blood pressure changes during moderate intensity strengthening exercises are unknown, and this study aims to quantify these among patients and compare them to those of healthy volunteers.

Purpose:

The purpose of this study is to investigate the increase in blood pressure during quadriceps muscle strength training in patients with aortic stent graft.

Methods:

Patients with aortic stent graft will be included. The participants are investigated once. During the investigation, the blood pressure increase during a single strength training exercise (leg press) is measured. The strength training exercise is done at 60% of maximal strength (moderate intensity) corresponding to 15 Repitition Maximum (RM) (a load that can be lifted exactly 15 times).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Aortic Stent Graft
Intervention  ICMJE Other: Moderate Intensity Muscle Strengthening
1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.
Study Arms  ICMJE
  • Experimental: Aortic stent graft patients
    Patients who have received an aortic stent graft who will perform one session of moderate intensity muscle strengthening during which blood pressure will be measured.
    Intervention: Other: Moderate Intensity Muscle Strengthening
  • Experimental: Healthy volunteers
    Healthy volunteers in general good health with no history of heart disease who will perform one session of moderate intensity muscle strengthening during which blood pressure will be measured.
    Intervention: Other: Moderate Intensity Muscle Strengthening
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2018)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
40
Actual Study Completion Date  ICMJE August 31, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria patients:

  • Adults (+18y) with aortic stent graft following aortic dissection or aneurism
  • Minimum 8 weeks post surgery
  • Strengthening exercise approved by treating cardiologist
  • Able to perform the exercise

Exclusion Criteria patients:

  • Lack of ability to read, speak or understand instructions in Danish or English
  • Other unspecified heart disease

Inclusion Criteria healthy volunteers:

  • Adults (+18y)
  • In good health (self report)

Exclusion Criteria healthy volunteers:

• Lack of ability to read, speak or understand instructions in Danish or English

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03424863
Other Study ID Numbers  ICMJE FYS014
Has Data Monitoring Committee No
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 Marius Henriksen, Frederiksberg University Hospital
Study Sponsor  ICMJE Marius Henriksen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christian Dall, PhD Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
PRS Account Frederiksberg University Hospital
Verification Date December 2018

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