Clinical trial NCT03684330: Vitamin D Supplementation and WBV in Inflammatory Markers, Strength and Body Composition in Old Patients With COPD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Aging
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: serum inflammatory marker Interleukine-6 (IL-6)
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: serum inflammatory marker Interleukine-8 (IL-8)
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: serum inflammatory marker TNF-alpha ( and BDNF)
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: serum inflammatory marker and brain derived neurotrophic factor (BDNF)
timeFrame: before and immediately up to 12 weeks in WBV training.
Secondary outcomes:
measure: Peripheral strength
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Body composition
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Respiratory strength
timeFrame: before and immediately up to 12 weeks in WBV training.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPE
state: Pernambuco
Study officials:
References: