NCT03684837Unknown不适用
D Vitamine Supplementation and Whole Body Vibration Altering Functional Outcomes
Maíra F Pessoa2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年3月20日最近更新:
适应症
干预措施
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
- Functional capacity
研究概览
简要总结
Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.
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
- Triple (Participant, Investigator, 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.
研究组 & 干预措施
D vitamine
Active Comparator
a dose for week
干预措施: Vitamine D supplementation (Dietary Supplement)
D vitamine
Active Comparator
a dose for week
干预措施: chronic exercise in whole body vibration (WBV) (Other)
D vitamine placebo
Placebo Comparator
a dose for week
干预措施: chronic exercise in whole body vibration (WBV) (Other)
结局指标
主要结局
Functional capacity
时间窗: before and immediately up to 12 weeks in WBV training.
Change in walk distance achieved in metres, measured during the six minute walk test
次要结局
- Peripheral strength(before and immediately up to 12 weeks in WBV training.)
- Body composition(before and immediately up to 12 weeks in WBV training.)
- Respiratory strength(before and immediately up to 12 weeks in WBV training.)
- Balance static and dynamic(before and immediately up to 12 weeks in WBV training.)
- Gait speed(before and immediately up to 12 weeks in WBV training.)
- Quality of life measure by WHOQOL(before and immediately up to 12 weeks in WBV training.)
研究者
Maíra F Pessoa
Clinical Professor
Universidade Federal de Pernambuco
研究点 (2)
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