NCT02754778

Brief Summary

Evaluation of practicability in survey and test procedures and of successful implementation of complex interventions - feasibility analysis based on a pilot study: Influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or HELLP-syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

April 22, 2016

Last Update Submit

March 1, 2023

Conditions

Keywords

arterial stiffnesspreeclampsiaHELLP-syndromepulse wave velocityadvanced glycation endproductsskin autofluorescenceconditional workoutpostpartumcardiovascular riskpregnancyvicorderage reader

Outcome Measures

Primary Outcomes (1)

  • reduced aortic pulse wave velocity by 1m/s

    six month

Secondary Outcomes (1)

  • no arterial hypertension defined as blood pressure ≤140mmHg / 80mmHg without antihypertensic medication

    13 years

Study Arms (2)

control group

NO INTERVENTION

no intervention, regular family life

intervention group

ACTIVE COMPARATOR

6 month of regular conditional workout 1-3 times a week

Behavioral: conditional workout

Interventions

6 month of regular conditional workout 1-3 times a weak

intervention group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of preeclampsia, superimposed gestosis or HELLP syndrome
  • capacity for content

You may not qualify if:

  • eclamptic stroke
  • New York Heart Association \> Stadium II
  • severe neurological or orthopedic disabilities
  • peripheral arterial occlusive disease
  • severe disease of the newborn which leads to an intensive familial care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Elisabeth and St. Barbara Hospital / Women's clinic

Halle, Saint, 06110, Germany

Location

Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Links

MeSH Terms

Conditions

Pre-EclampsiaHELLP Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Marcus Riemer, Dr. med.

    Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR
  • Gregor Seliger, Dr. med.

    Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Gregor Seliger

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 28, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

March 1, 2021

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations