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

NCT03424863 | Completed

• 1 other identifier: FYS014
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Stent Graft

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Aortic stent graft patients

EXPERIMENTAL

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

Healthy volunteers

EXPERIMENTAL

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

Interventions

Moderate Intensity Muscle Strengthening OTHER

1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.

Aortic stent graft patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lack of ability to read, speak or understand instructions in Danish or English
• Other unspecified heart disease
• Adults (+18y)
• In good health (self report)
• Lack of ability to read, speak or understand instructions in Danish or English

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, 2400, Denmark

Location

Study Officials

• Christian Dall, PhD

  Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 7, 2018
• Study Start: February 22, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

DK (1)