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

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

Official Title
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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

Conditions
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COPD, Aging

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Other: whole body vibration (WBV)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D supplementation<br> | Dietary Supplement: Vitamin D<br>* a dose once a week<br>Other: whole body vibration (WBV)<br>* 03 months of WBV training three times per week<br>|
| Placebo Comparator: Vitamin D placebo<br> | Other: whole body vibration (WBV)<br>* 03 months of WBV training three times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Body composition | Changes in electrical bioimpedance assessing lean mass in segmental areas and trunk | before and immediately up to 12 weeks in WBV training. | 
| 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. |