D Vitamine and Whole Body Vibration in Functional Outcomes

NCT ID: NCT03684837

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2018-09-30

Brief 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.

Conditions

COPD; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

D vitamine

a dose for week

Group Type: ACTIVE_COMPARATOR

Vitamine D supplementation

Intervention Type: DIETARY_SUPPLEMENT

a vitamine D dose for week

chronic exercise in whole body vibration (WBV)

Intervention Type: OTHER

exercise in WBV during 03 months, e times per week

D vitamine placebo

a dose for week

Group Type: PLACEBO_COMPARATOR

chronic exercise in whole body vibration (WBV)

Intervention Type: OTHER

exercise in WBV during 03 months, e times per week

Interventions

Vitamine D supplementation

a vitamine D dose for week

Intervention Type: DIETARY_SUPPLEMENT

chronic exercise in whole body vibration (WBV)

exercise in WBV during 03 months, e times per week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maíra F Pessoa

OTHER

Sponsor Role: lead

Responsible Party

Maíra F Pessoa

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Federal University of Pernambuco

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

COPDinfl

Identifier Type: -

Identifier Source: org_study_id