Acute Effect of Strength Training on Blood Pressure in Ca... | NCT01912248

Studies
Acute Effect of Strength Training on Blood Pressure in Cardiac Patients

NCT01912248

Sponsor

Christian Dall

Status

Completed

Last Update Posted

Jan 27, 2015Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Heart Failure
Ischemic Heart Disease
Heart Transplant Recipients

Interventions

strength training

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Jul 30, 2013

First Posted Date

Jul 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2015

Last Update Posted Date

Jan 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Heart failure	strength training	Other: strength training
Heart Transplant recipients	strength training	Other: strength training
patients with ischemic heart disease	strength training	Other: strength training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
strength training	Other	strength training, lower limb.	Heart Transplant recipients Heart failure patients with ischemic heart disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
systolic blood pressure		one test, 1 hour, continuated systolic blood pressure surveliance

Secondary Outcomes

Measure	Description	Time Frame
diastolic blood pressure		one test 1 hour, continuated bloodpressure surveliance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years
no strength training > 3 month
speak and understand danish

Exclusion Criteria:

cancer
serum creatinin above 200 mmol/l
re-transplantation
Ejection fraction > 35

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

12 heart transplant recipients 12 heart failure patients 12 patients with ischemic disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian H Dall, cand.scient	Bispebjerg Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christian Dall		Copenhagen		2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided