Evaluation of Cardiac Variability After a Vitamine D Protocol and Whole Body Vibration

September 20, 2018 updated by: Maíra F Pessoa

Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol

Evaluation of heart rate variability in time and frequency domains, in Chronic Obstructive Pulmonary Disease (COPD) after 03 months of vitamine D supplementation and whole body vibration (WBV) training

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Federal University of Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD or healthy elderly sedentary according to International Physical Activity Questionnaire
  • BMI between 22.9 and 28 kg/m2
  • COPD with clinical-functional diagnosis of the disease according to Gold
  • ex-smokers

Exclusion Criteria:

  • Older patients with COPD who had episodes of exacerbation in the last three months
  • Who participate in pulmonary rehabilitation programs in the last year
  • Who used home oxygen therapy
  • Patients with COPD-associated comorbidities
  • Who were taking vitamin D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vitamine D
a dose once a week
Dietary supplement: vitamine D
a dose once a week
Other: whole body vibration (WBV)
03 months of WBV training three times per week
Placebo Comparator: vitamine D placebo
a dose once a week
Other: whole body vibration (WBV)
03 months of WBV training three times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate variability
Time Frame: before and immediately after the chronic intervention
evaluation of time and frequency domains
before and immediately after the chronic intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maíra F Pessoa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Anticipated)

September 30, 2018

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPDcardiac variability

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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