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

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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

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).


Condition or disease Intervention/treatment Phase
Aortic Stent Graft Other: Moderate Intensity Muscle Strengthening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Peak Systolic Blood Pressure in Heart Patients With Aortic Stent-graft During Moderate Intensity Strength Training: A Descriptive Intervention Study
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424863


Locations
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Denmark
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Marius Henriksen
Investigators
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Study Chair: Christian Dall, PhD Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

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Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT03424863     History of Changes
Other Study ID Numbers: FYS014
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No