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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679325
Recruitment Status : Unknown
Verified September 2018 by Maíra F Pessoa, Universidade Federal de Pernambuco.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Maíra F Pessoa, Universidade Federal de Pernambuco

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Copd Aging Dietary Supplement: vitamine D Other: whole body vibration (WBV) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : August 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. heart rate variability [ Time Frame: before and immediately after the chronic intervention ]
    evaluation of time and frequency domains


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679325


Locations
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Brazil
Federal University of Pernambuco
Recife, Pernambuco, Brazil, 50670-901
Sponsors and Collaborators
Maíra F Pessoa
More Information
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Responsible Party: Maíra F Pessoa, Clinical Professor, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03679325    
Other Study ID Numbers: COPDcardiac variability
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents