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

Peak Systolic Blood Pressure in Heart Patients With Aortic Stent-graft During Moderate Intensity Strength Training: A Descriptive Intervention Study

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).

Study Overview

• Status: Completed
• Conditions: Aortic Stent Graft
• Intervention / Treatment: Other: Moderate Intensity Muscle Strengthening

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital, Department of Physical and Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak systolic pressure during a single lower extremity muscle strengthening exercise	Blood pressure is measured continuously using a finger clamp measurement device (Nexfin)	5 minutes: 15 repetitions of leg press muscle strength exercise.

Collaborators and Investigators

• Sponsor: Marius Henriksen
• Investigators: Study Chair: Christian Dall, PhD, Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FYS014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No