Aortic Stent GraftNCT03424863
Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients
A study testing Moderate Intensity Muscle Strengthening in people with Aortic Stent Graft, run by Marius Henriksen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stent Graft
- What is being tested?
- Moderate Intensity Muscle Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Feb 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Adults (+18y)
- In good health (self report)
Who cannot join
- Lack of ability to read, speak or understand instructions in Danish or English
- Other unspecified heart disease
- Lack of ability to read, speak or understand instructions in Danish or English
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, 2400
About this study
Official title: 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:
Read more
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
- Being tested
- Moderate Intensity Muscle Strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Muscle StrengtheningOther
1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Moderate Intensity Muscle Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systolic pressure during a single lower extremity muscle strengthening exercise
Blood pressure is measured continuously using a finger clamp measurement device (Nexfin)
Measured: 5 minutes: 15 repetitions of leg press muscle strength exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start22 Feb 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stent GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Christian Dall, PhD, Study chair, Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424863
- Sponsor's protocol ID
- FYS014
- Status last verified
- Dec 2018
- First submitted
- 26 Jan 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Systolic Blood Pressure in Heart Patients With Aortic Stent-graft During Moderate Intensity Strength Training: A Descriptive Intervention Study
- ClinicalTrials.gov ID
- NCT03424863
- Acronym / sponsor ID
- FYS014
- Conditions
- Aortic Stent Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic stent graft patients | Experimental | Other: Moderate Intensity Muscle StrengtheningPatients who have received an aortic stent graft who will perform one session of moderate intensity muscle strengthening during which blood pressure will be measured. |
| Healthy volunteers | Experimental | Other: Moderate Intensity Muscle StrengtheningHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Adults (+18y)
Key exclusion criteria (3 listed)
- Lack of ability to read, speak or understand instructions in Danish or English
- Other unspecified heart disease
- Lack of ability to read, speak or understand instructions in Danish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity Muscle Strengthening1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day. | Other | Aortic stent graft patients, Healthy volunteers |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Stent Graft
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Recruiting
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
Technical Sucess, Freedom From Type I and III Endoleaks at 12 Months
Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Type B Aortic Dissection
Recruiting
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Dall, PhD study chair
Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Muscle Strengthening in people with Aortic Stent Graft, run by Marius Henriksen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak systolic pressure during a single lower extremity muscle strengthening exercise (time frame: 5 minutes: 15 repetitions of leg press muscle strength exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.