CopdNCT03679325
Evaluation of Cardiac Variability After a Vitamine D Protocol and Whole Body Vibration
A study testing vitamine D and whole body vibration (WBV) in people with Copd and Aging, run by Maíra F Pessoa at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- What is being tested?
- vitamine D and whole body vibration (WBV)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- 20 May 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- vitamine D, whole body vibration (WBV)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamine DDietary supplement
a dose once a week
whole body vibration (WBV)Other
03 months of WBV training three times per week
| Study group | Role | What they receive |
|---|---|---|
| vitamine D | Active comparator | a dose once a week Receives: Dietary Supplement: vitamine D; Other: whole body vibration (WBV) |
| vitamine D placebo | Placebo comparator | a dose once a week Receives: Other: whole body vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
evaluation of time and frequency domains
Measured: before and immediately after the chronic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start20 May 2018
- Primary completion30 Aug 2018
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maíra F Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maíra F Pessoa, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679325
- Sponsor's protocol ID
- COPDcardiac variability
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39329240
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol
- ClinicalTrials.gov ID
- NCT03679325
- Acronym / sponsor ID
- COPDcardiac variability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Maíra F PessoaUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamine D | Active comparator | Dietary Supplement: vitamine D, Other: whole body vibration (WBV)a dose once a week |
| vitamine D placebo | Placebo comparator | Other: whole body vibration (WBV)a dose once a week |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamine Da dose once a week | Dietary supplement | vitamine D |
| whole body vibration (WBV)03 months of WBV training three times per week | Other | vitamine D, vitamine D placebo |
Primary outcome
heart rate variability
Time frame: before and immediately after the chronic intervention
evaluation of time and frequency domains
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Derived from this study: PubMed 39329240Williamson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamine D and whole body vibration (WBV) in people with Copd and Aging, run by Maíra F Pessoa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: before and immediately after the chronic intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.