NCT03684330

Brief Summary

Verify the influence off vitamin D supplementation and a whole body vibration (WBV) protocol during 03 months in older patients chronic obstructive pulmonary disease

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
23 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 22, 2018

Last Update Submit

September 24, 2018

Conditions

COPDAging

Outcome Measures

Primary Outcomes (4)

  • serum inflammatory marker Interleukine-6 (IL-6)

    changes in total serum values of interleukine 6

    before and immediately up to 12 weeks in WBV training.

  • serum inflammatory marker Interleukine-8 (IL-8)

    changes in total serum values of interleukine 8

    before and immediately up to 12 weeks in WBV training.

  • serum inflammatory marker TNF-alpha ( and BDNF)

    changes in total serum values of tumoral necrose factor alpha

    before and immediately up to 12 weeks in WBV training.

  • serum inflammatory marker and brain derived neurotrophic factor (BDNF)

    changes in total serum values of brain derived neurotrophic factor

    before and immediately up to 12 weeks in WBV training.

Secondary Outcomes (3)

  • Peripheral strength

    before and immediately up to 12 weeks in WBV training.

  • Body composition

    before and immediately up to 12 weeks in WBV training.

  • Respiratory strength

    before and immediately up to 12 weeks in WBV training.

Study Arms (2)

Vitamin D supplementation

ACTIVE COMPARATOR
Dietary Supplement: Vitamin DOther: whole body vibration (WBV)

Vitamin D placebo

PLACEBO COMPARATOR
Other: whole body vibration (WBV)

Interventions

Vitamin DDIETARY_SUPPLEMENT

a dose once a week

Vitamin D supplementation
whole body vibration (WBV)OTHER

03 months of WBV training three times per week

Vitamin D placeboVitamin D supplementation

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFPE

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 22, 2018

First Posted

September 25, 2018

Study Start

May 20, 2018

Primary Completion

August 30, 2018

Study Completion

September 30, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

BR(1)