NCT02479269

Brief Summary

The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to avoid any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. Blood samples for subsequent measurements were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood samplings were performed. Exercise intensity according to the heart rate remained stable until the last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA tests. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

June 13, 2015

Last Update Submit

May 8, 2016

Conditions

Keywords

Brain Natriuretic Peptideaerobic execiseC- Reactive Protein

Outcome Measures

Primary Outcomes (2)

  • Brain Natriuretic Peptide

    8 weeks

  • serum C - reactive protein

    8 weeks

Secondary Outcomes (3)

  • serum lipoproteins

    8 weeks

  • Body Mass Index

    8 weeks

  • blood pressure

    8 weeks

Study Arms (2)

intervention

EXPERIMENTAL

Aerobic exercise+ blood sampling

Other: Aerobic exercise

control

NO INTERVENTION

Blood sampling

Interventions

Aerobic exercise for 8 weeks

intervention

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.

You may not qualify if:

  • Patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr Mohammad Ali Ostovan, Cardiologist

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

June 13, 2015

First Posted

June 24, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 10, 2016

Record last verified: 2016-05