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

Aortic Stent Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424863
• Other study ID #: FYS014
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2018
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stent Graft

Intervention

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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Physical and Occupational Therapy	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.