NCT02198872

Brief Summary

In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest. 2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

July 15, 2014

Last Update Submit

July 23, 2014

Conditions

Keywords

Autonomic Nervous System, Body composition, Oxygen Uptake,Water Based Physical Training, Land Based Physical Training.

Outcome Measures

Primary Outcomes (1)

  • Change in autonomic system modulation

    Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.

    baseline and 16 weeks

Secondary Outcomes (1)

  • Change in body composition

    16 weeks

Other Outcomes (1)

  • Oxygen uptake

    16 Weeks

Study Arms (2)

Exercise, Aerobic (Water based)

EXPERIMENTAL

Patients of this group will be submitted to an aerobic water based physical training

Other: Exercise, Aerobic (Water based)

Land Group

ACTIVE COMPARATOR

Patients of this group perform physical training on bicycle.

Other: Land Group

Interventions

Patients of this group will be submitted to an aerobic water based physical training

Exercise, Aerobic (Water based)

Patients of this group perform physical training on bicycle.

Land Group

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis by angiography
  • sedentaries
  • family story of cardiac disease
  • obesity

You may not qualify if:

  • frequent arrhythmias at rest
  • triggered by physical effort
  • unstable angina
  • chronic obstructive pulmonary disease
  • insulin-dependent diabet
  • renal failure
  • sequel of stroke
  • uncontrolled hypothyroidism
  • water phobia
  • skin infections, allergic reactions to chlorine,
  • urinary incontinence and
  • musculoskeletal and neuromuscular disorders precluding physical tests and training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metodista de Piracicaba

Piracicaba, São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elie Fiogbé, Ms

    Universidade Metodista de Piracicaba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elie Fiogbé, Ms

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 24, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

February 1, 2018

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations