NCT02116114

Brief Summary

We have as hypothesis that the aquatic aerobic physical training program can help promote beneficial adaptations on the cardiovascular, respiratory and systemic inflammation variables, functional capacity and quality of life in patients with chronic obstructive pulmonary disease (pulmonary emphysema).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2011

Enrollment Period

7 months

First QC Date

April 14, 2014

Last Update Submit

April 14, 2014

Conditions

Keywords

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cardiac autonomic modulation by heart rate variability at week 8

    Baseline, Week 8

Secondary Outcomes (1)

  • Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8

    Baseline, Week 8

Other Outcomes (1)

  • Change from baseline in systemic inflammation by C-reactive protein at week 8

    Baseline, Week 8

Study Arms (2)

Aquatic exercises

EXPERIMENTAL

* 3 times a week * heating * aerobic training * slowdown

Other: Aerobic training

control group

NO INTERVENTION

The control group participated in the study only to usual care , conventional medical treatment orientation about the disease , methods of energy conservation and evaluation.

Interventions

The program of aquatic exercise training was developed involving the following steps : heating : dynamic stretching exercises aerobic exercises , lasting 10 minutes was performed, aquatic fitness : aerobic training and slowdown. The intensity was prescribed based on the Borg scale score 4-6. Aerobic training was performed at intervals. The duration of aerobic fitness was started with eight 20-minute sessions , progressing to eight sessions of 30 minutes and finished with eight 40-minute sessions. Downturn : global stretching exercises , lasting 10 minutes were performed. During all sessions , the patients were instructed to breath with pursed - lip .

Aquatic exercises

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of COPD ( GOLD I / II / III / IV rating )
  • Clinically stable
  • Low level of physical activity , according to the IPAQ ( International Physical Activity Questionnaire )
  • Absence of exacerbation in the last three months
  • Do not participate in a regular exercise program in the past six months

You may not qualify if:

  • Diabetes Mellitus
  • Endocrine Disorders
  • Chronic renal failure
  • Liver Diseases
  • Other lung diseases or inflammatory diseases associated
  • Cardiac
  • Use of drugs that prevented physical performance
  • Musculoskeletal and neuromuscular changes that make it impossible to run experimental protocols
  • Dermatological disorders ( cutaneous fistulas , infected wounds , ringworm skin , varicose ulcers )
  • Hypersensitivity to the product used for the treatment of pool water
  • Rabies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruna G Silva, Master

    Universidade Metodista de Piracicaba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlene A Moreno, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pos doctorate

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 16, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 16, 2014

Record last verified: 2011-04