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临床试验/NCT03604952
NCT03604952已完成不适用

Effects of Ramadan Observance on Pulmonary Variables, Exercise Performance and Postural Balance in Male Patients With Chronic Obstructive Pulmonary Disease

Faculty of Medicine, Sousse1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
6-min walking test

研究概览

简要总结

Purpose: To analyze the effects of Ramadan observance (RO) on pulmonary variables, exercise performance and postural balance in patients with chronic obstructive pulmonary disease (COPD).

Methods: Twenty COPD patients (age=72.7 ± 4.1 yr, non-smokers, without cardiac or neuromuscular complications) were evaluated. Tests performed one week before Ramadan (C), and during the second (R-2) and the fourth weeks of Ramadan (R-4) included standard spirometry, a quality of life questionnaire (VQ11), a 6-min walking test (6MWT), measurement of maximal voluntary contraction force of the quadriceps (MVC), Timed Get Up and Go (TUG), Berg Balance Scale (BBS) and Unipedal Stance (UST).

详细描述

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide ; prevalence is high in Tunisia, with 7.8 % and 4.2 % of the population in disease stages 1 and 2 respectively . Patients with COPD show an impaired exercise tolerance, often with severe dyspnea, a decreased ability to participate in the activities of daily living, and a poor health-related quality of life.

The common practice of those observing Ramadan is to have two meals per day: a large meal shortly after sunset and a much lighter one immediately before dawn. Ramadan observance (RO) is characterized by many changes in diet and sleep patterns , often with a decrease in the time available for nocturnal sleep . Studies in athletes have shown altered muscle metabolism , hormonal changes , and an impaired physical performance depending on the time of day at which test sessions were performed . Sometimes there are disturbances of cognitive function , and Patel et al noted decreases in postural control even in young adults, due to momentary lapses of attention after sleep deprivation . Such changes are of particular concern in elderly patients with COPD, since their ability to carry out the activities of daily living may initially be marginal, and any disturbances of balance and cognitive function associated with RO could increase the risk of falls .

To date, only one previous study has examined the effects of Ramadan observance in patients with COPD ; this report focused almost exclusively upon changes in medication use during RO. Most Muslim patients with COPD observe Ramadan (for example, 93% in Turkey ), but little is known about the clinical and physiological effects of such fasting in COPD .Thus, the aim of the present study was to analyze the effects of RO on pulmonary variables, exercise performance and postural balance in patients with COPD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
67 Years 至 77 Years(Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Clinically stable individuals with a functional diagnosis of COPD according to the global strategy for the diagnosis, management and prevention of COPD guideline were selected
  • •medication remained unchanged during Ramadan).Smokers

排除标准

  • •those with cardiovascular or neurological disease, lower extremity musculoskeletal problems and visual deficits that could affect postural control were excluded

结局指标

主要结局

6-min walking test

时间窗: 6 min

Exercise Performance was assessed by 6MWT , performed indoors, along a flat, straight, 30 m walking course with a tiled surface; chairs were placed in case participants needed to rest

the Berg balance scale

时间窗: 10 MIN

The BBS is a psychometrically robust clinical measurement of balance for older adults. It assesses performance on 5 levels, from 0 (cannot perform) to 4 (normal performance), with14 items involving functional balance control, including transfer, turning and stepping; a perfect score is 56

The timed get up and go (TUG),

时间窗: 15 seconds

The TUG score reflects both balance and functional mobility . The time taken to stand from a chair, walk a distance of 3 meters, turn around, return to the chair, and sit down was recorded

the Unipedal stance

时间窗: 45 secondes

The UST measures the participant's ability to stand on his preferred leg. A unipedal stance is maintained for a long as possible; failure is defined as shifting the stance foot or placing the lifted foot on the floor. The UST was considered normal if the unipedal stance was maintained for 45 seconds or longer

standard spirometry

时间窗: 15 MIN

Pulmonary function was tested using a Zan 100 spirometer (Inspire Health GmbH, Germany) according to Respiratory Society recommendations, with data related to Tunisian norms

次要结局

  • Isometric leg force assessment(5 secondes)
  • Quality of life questionnaire (VQ 11)(10 min)

研究者

发起方
Faculty of Medicine, Sousse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Mekki

Avenue Mohamed Karoui, 4002, Sousse, Tunisia

Faculty of Medicine, Sousse

研究点 (1)

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