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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- serum inflammatory marker Interleukine-6 (IL-6)
研究概览
简要总结
Verify the influence off vitamin D supplementation and a whole body vibration (WBV) protocol during 03 months in older patients chronic obstructive pulmonary disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older patients with COPD
- •Both genders
- •Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
- •BMI in between 22.9 and 28 kg/m
- •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.
排除标准
- •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.
结局指标
主要结局
serum inflammatory marker Interleukine-6 (IL-6)
时间窗: before and immediately up to 12 weeks in WBV training.
changes in total serum values of interleukine 6
serum inflammatory marker and brain derived neurotrophic factor (BDNF)
时间窗: before and immediately up to 12 weeks in WBV training.
changes in total serum values of brain derived neurotrophic factor
serum inflammatory marker Interleukine-8 (IL-8)
时间窗: before and immediately up to 12 weeks in WBV training.
changes in total serum values of interleukine 8
serum inflammatory marker TNF-alpha ( and BDNF)
时间窗: before and immediately up to 12 weeks in WBV training.
changes in total serum values of tumoral necrose factor alpha
次要结局
- Peripheral strength(before and immediately up to 12 weeks in WBV training.)
- Respiratory strength(before and immediately up to 12 weeks in WBV training.)
- Body composition(before and immediately up to 12 weeks in WBV training.)
研究者
Maíra F Pessoa
Clinical Professor
Universidade Federal de Pernambuco