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

COPD Clinical Trial

Official title:

Efficacy of Vitamin D Supplementation Added to WBV Chronic Protocol in Inflammatory Markers, Peripheral and Respiratory Strength and Body Composition in Old Patients With COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03684330
• Other study ID #: croninflam
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2018
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• COPD

Intervention

Dietary Supplement:
• Vitamin D
a dose once a week

Other:
• whole body vibration (WBV)
03 months of WBV training three times per week

Locations

Country	Name	City	State
Brazil	UFPE	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Maíra F Pessoa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Peripheral strength	Changes in Peripheral muscle strength assessed by the hand dynamometer (device that assess strength) in values obtained from the mean of 03 maneuvers of isokinetic contraction, in centimeters of water	before and immediately up to 12 weeks in WBV training.
Secondary	Body composition	Changes in electrical bioimpedance assessing lean mass in segmental areas and trunk	before and immediately up to 12 weeks in WBV training.
Secondary	Respiratory strength	Changes in respiratory strength obtained from a manovacuometer, collecting the major value of 03 maneuvers of the maximal inspiration (vacuometer) to the maximal expiration pressures (manometer), with values obtained in centimeters of water	before and immediately up to 12 weeks in WBV training.