NCT03679325

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 19, 2018

Last Update Submit

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 COMPARATOR

a dose once a week

Dietary Supplement: vitamine DOther: whole body vibration (WBV)

vitamine D placebo

PLACEBO COMPARATOR

a dose once a week

Other: whole body vibration (WBV)

Interventions

vitamine DDIETARY_SUPPLEMENT

a dose once a week

vitamine D

03 months of WBV training three times per week

vitamine Dvitamine D placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

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

Locations