Clinical trial NCT03604952: Effects of Ramadan Observance in Male Patients With Chronic Obstructive Pulmonary Disease
Official title: Effects of Ramadan Observance on Pulmonary Variables, Exercise Performance and Postural Balance in Male Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: chronic obstructive pulmonary disease
Ramadan observance
pulmonary variables
postural balance
exercise performance
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 20
Sex: MALE
Minimum age (years): 67
Maximum age (years): 77
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in this study were 20 male volunteers with COPD

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: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

Exclusion Criteria:

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

Primary outcomes:
measure: standard spirometry
timeFrame: 15 MIN
measure: 6-min walking test
timeFrame: 6 min
measure: The timed get up and go (TUG),
timeFrame: 15 seconds
measure: the Berg balance scale
timeFrame: 10 MIN
measure: the Unipedal stance
timeFrame: 45 secondes
Secondary outcomes:
measure: Isometric leg force assessment
timeFrame: 5 secondes
measure: Quality of life questionnaire (VQ 11)
timeFrame: 10 min
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Faculty of Medicine of Sousse
Study officials:
References: