Vitamin D Supplementation and WBV in Inflammatory Markers, Strength and Body Composition in Old Patients With COPD

NCT ID: NCT03684330

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-20
• Study Completion Date: 2018-09-30

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

Conditions

COPD; Aging

Study Design

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

Study Groups

Vitamin D supplementation

Group Type: ACTIVE_COMPARATOR

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

a dose once a week

whole body vibration (WBV)

Intervention Type: OTHER

03 months of WBV training three times per week

Vitamin D placebo

Group Type: PLACEBO_COMPARATOR

whole body vibration (WBV)

Intervention Type: OTHER

03 months of WBV training three times per week

Interventions

Vitamin D

a dose once a week

Intervention Type: DIETARY_SUPPLEMENT

whole body vibration (WBV)

03 months of WBV training three 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

UFPE

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

croninflam

Identifier Type: -

Identifier Source: org_study_id