Heart FailureNCT01912248
Acute Effect of Strength Training on Blood Pressure in Cardiac Patients
An observational study of Heart Failure and Ischemic Heart Disease, run by Christian Dall at 1 site in Denmark.
Trial summary
Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac patient, how high? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Ischemic Heart Disease, Heart Transplant Recipients
- What is being tested?
- strength training
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Apr 2014
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 12 heart transplant recipients 12 heart failure patients 12 patients with ischemic disease
Who may be able to join
- 18 years
- no strength training > 3 month
- speak and understand danish
Who cannot join
- cancer
- serum creatinin above 200 mmol/l
- re-transplantation
- Ejection fraction > 35
Trial locations and contacts
1 site in 1 country.
About this study
Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac patient, how high?
Read the detailed description
12 heart transplant recipients 12 heart failure patients 12 patients with ischemic heart disease
- Being tested
- strength training
- Keywords
- acute rise of systolic and diastolic bloodpressure
- Medical subject headings
- Heart Failure, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strength trainingOther
Also called one hour of strength training.
strength training, lower limb.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | strength training Receives: Other: strength training | |
| Heart Transplant recipients | strength training Receives: Other: strength training | |
| patients with ischemic heart disease | strength training Receives: Other: strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Measured: one test, 1 hour, continuated systolic blood pressure surveliance
Secondary outcomes (1)
diastolic blood pressure
Measured: one test 1 hour, continuated bloodpressure surveliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Dall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Dall, Bispebjerg Hospital
- Investigators
- Christian H Dall, cand.scient, Principal investigator, Bispebjerg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912248
- Sponsor's protocol ID
- H-2-2012-143
- Status last verified
- Jan 2015
- First submitted
- 29 Jul 2013
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Strength Training on Blood Pressure in Cardiac Patients
- ClinicalTrials.gov ID
- NCT01912248
- Acronym / sponsor ID
- H-2-2012-143
- Keywords
- acute rise of systolic and diastolic bloodpressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Christian DallUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
Moderate and heavy strength training exercise and the acute blood pressure rise in cardiac patient, how high?
Detailed description
12 heart transplant recipients 12 heart failure patients 12 patients with ischemic heart disease
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | Other: strength trainingstrength training |
| Heart Transplant recipients | – | Other: strength trainingstrength training |
| patients with ischemic heart disease | – | Other: strength trainingstrength training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 12 heart transplant recipients 12 heart failure patients 12 patients with ischemic disease
Key inclusion criteria (3 listed)
- 18 years
- no strength training > 3 month
- speak and understand danish
Key exclusion criteria (4 listed)
- cancer
- serum creatinin above 200 mmol/l
- re-transplantation
- Ejection fraction > 35
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 |
|---|---|---|
| strength trainingAlso: one hour of strength training.strength training, lower limb. | Other | Heart Transplant recipients, Heart failure, patients with ischemic heart disease |
Primary outcome
systolic blood pressure
Time frame: one test, 1 hour, continuated systolic blood pressure surveliance
1 secondary outcome
diastolic blood pressure
Time frame: one test 1 hour, continuated bloodpressure surveliance
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 27 Jan 2015.
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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 H Dall, cand.scient principal investigator
Bispebjerg Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ischemic Heart Disease, run by Christian Dall 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 3 inclusion and 4 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 27 Jan 2015. 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?
systolic blood pressure (time frame: one test, 1 hour, continuated systolic blood pressure surveliance). 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 27 Jan 2015.