NCT02211573

Brief Summary

Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

August 5, 2014

Last Update Submit

August 5, 2014

Conditions

Keywords

Autonomic Nervous System, Body composition, Oxygen Uptake,Water 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

    baseline and 16 weeks

Other Outcomes (1)

  • Oxygen uptake

    16 Weeks

Study Arms (2)

Control group

NO INTERVENTION

Patients of this group don't performed physical training

Exercise, Aerobic (Water based)

EXPERIMENTAL

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

Other: Exercise, Aerobic (Water based)

Interventions

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

Exercise, Aerobic (Water based)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 5, 2014

First Posted

August 7, 2014

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

March 1, 2014

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations