COPDNCT03684837
D Vitamine and Whole Body Vibration in Functional Outcomes
A study testing Vitamine D supplementation and chronic exercise in whole body vibration (WBV) in people with COPD and Aging, run by Maíra F Pessoa at 1 site in Brazil.
Trial summary
Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- What is being tested?
- Vitamine D supplementation and chronic exercise in 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 Mar 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
- Older patients with COPD
- Both genders
- Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
- BMI in between 22.9 and 28 kg/m2.
- Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
- Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.
Who cannot join
- Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD-associated comorbidities were excluded.
- Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D Vitamine Supplementation and Whole Body Vibration Altering Functional Outcomes
Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.
- Being tested
- Vitamine D supplementation, chronic exercise in 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 D supplementationDietary supplement
a vitamine D dose for week
chronic exercise in whole body vibration (WBV)Other
exercise in WBV during 03 months, e times per week
| Study group | Role | What they receive |
|---|---|---|
| D vitamine | Active comparator | a dose for week Receives: Dietary Supplement: Vitamine D supplementation; Other: chronic exercise in whole body vibration (WBV) |
| D vitamine placebo | Placebo comparator | a dose for week Receives: Other: chronic exercise in whole body vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Change in walk distance achieved in metres, measured during the six minute walk test
Measured: before and immediately up to 12 weeks in WBV training.
Secondary outcomes (6)
Balance static and dynamic
Change in total scores of Tinetti index, composed by 16 items divided into 2 sections: static balance (9 items) with 16 points and gait or dynamic balance (7 items) with 12 points, summed in a total score of 28 points. Individuals scoring < 26 points have a risk for falling.
Measured: before and immediately up to 12 weeks in WBV training.
Gait speed
Change in time in seconds registered in Timed Up and Go test
Measured: before and immediately up to 12 weeks in WBV training.
Body composition
Change in electrical bioimpedance measuring the fat mass and lean mass in kilograms each one, in total body
Measured: before and immediately up to 12 weeks in WBV training.
Quality of life measure by WHOQOL
Change in total value obtained from WHOQOL-old questionnaire (World Health Organization of Quality Of Life) that evaluate in older the domains: sensory abilities; autonomy; past, present and future activities; social participation; death \& dying; and intimacy. The Quality of life needs to improve when it is 1 to 2,9; is regular 3 to 3.9 points; good between 4 up to 4.9 and very good with 5 points.
Measured: before and immediately up to 12 weeks in WBV training.
Peripheral strength
Change in mean value obtained from 03 maneuvers of isokinetic contraction in a hand dynamometer (device that measure strength in handgrip), measured in centimeters of water.
Measured: before and immediately up to 12 weeks in WBV training.
Respiratory strength
Change in major value obtained after 03 maneuvers in manovacuometer (device that measure manometry for expiratory pressure and vacuum generated for the inspiratory pressure), all in centimeters of water.
Measured: before and immediately up to 12 weeks in WBV training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start20 Mar 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, 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
- NCT03684837
- Sponsor's protocol ID
- COPDinfl
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D Vitamine Supplementation and Whole Body Vibration Altering Functional Outcomes
- ClinicalTrials.gov ID
- NCT03684837
- Acronym / sponsor ID
- COPDinfl
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Maíra F PessoaUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 26 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.
Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D vitamine | Active comparator | Dietary Supplement: Vitamine D supplementation, Other: chronic exercise in whole body vibration (WBV)a dose for week |
| D vitamine placebo | Placebo comparator | Other: chronic exercise in whole body vibration (WBV)a dose for week |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older patients with COPD
- Both genders
- Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
- BMI in between 22.9 and 28 kg/m2.
- Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
Key exclusion criteria (2 listed)
- Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD-associated comorbidities were excluded.
- Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.
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 D supplementationa vitamine D dose for week | Dietary supplement | D vitamine |
| chronic exercise in whole body vibration (WBV)exercise in WBV during 03 months, e times per week | Other | D vitamine, D vitamine placebo |
Primary outcome
Functional capacity
Time frame: before and immediately up to 12 weeks in WBV training.
Change in walk distance achieved in metres, measured during the six minute walk test
6 secondary outcomes
Balance static and dynamic
Time frame: before and immediately up to 12 weeks in WBV training.
Gait speed
Time frame: before and immediately up to 12 weeks in WBV training.
Body composition
Time frame: before and immediately up to 12 weeks in WBV training.
Quality of life measure by WHOQOL
Time frame: before and immediately up to 12 weeks in WBV training.
Peripheral strength
Time frame: before and immediately up to 12 weeks in WBV training.
Respiratory strength
Time frame: before and immediately up to 12 weeks in WBV training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: No
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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 supplementation and chronic exercise in 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 6 inclusion and 2 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 26 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?
Functional capacity (time frame: before and immediately up to 12 weeks in WBV training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2018.