Evaluation of Cardiac Variability After a Vitamine D Protocol and Whole Body Vibration
Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol
1 other identifier
interventional
59
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedFirst Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedSeptember 24, 2018
September 1, 2018
3 months
September 19, 2018
September 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
heart rate variability
evaluation of time and frequency domains
before and immediately after the chronic intervention
Study Arms (2)
vitamine D
ACTIVE COMPARATORa dose once a week
vitamine D placebo
PLACEBO COMPARATORa dose once a week
Interventions
03 months of WBV training three times per week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maíra F Pessoalead
Study Sites (1)
Federal University of Pernambuco
Recife, Pernambuco, 50670-901, Brazil
Related Publications (1)
Williamson A, Martineau AR, Jolliffe D, Sheikh A, Janssens W, Sluyter J, Rafiq R, de Jongh R, Griffiths CJ. Vitamin D for the management of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2024 Sep 27;9(9):CD013284. doi: 10.1002/14651858.CD013284.pub2.
PMID: 39329240DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 20, 2018
Study Start
May 20, 2018
Primary Completion
August 30, 2018
Study Completion
September 30, 2018
Last Updated
September 24, 2018
Record last verified: 2018-09