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Completed

NCT Number: NCT03424863

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Marius Henriksen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2018
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.