Effects of Ramadan Observance in Male Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604952
• Other study ID #: Faculty of Medicine of Sousse,
• Status: Completed
• Start date: June 18, 2015
• Est. completion date: July 16, 2015

Study information

• Verified date: July 2018
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 16, 2015
• Est. primary completion date: July 14, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 67 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• COPD patients
Tests performed one week before Ramadan (C), and during the second (R-2) and the fourth weeks of Ramadan (R-4)

Locations

Country	Name	City	State
Tunisia	Faculty of Medicine of Sousse	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standard spirometry	Pulmonary function was tested using a Zan 100 spirometer (Inspire Health GmbH, Germany) according to Respiratory Society recommendations, with data related to Tunisian norms	15 MIN
Primary	6-min walking test	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	6 min
Primary	The timed get up and go (TUG),	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	15 seconds
Primary	the Berg balance scale	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	10 MIN
Primary	the Unipedal stance	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	45 secondes
Secondary	Isometric leg force assessment	After a warm-up phase of the leg extensor muscle consisting of 5 min cycling at 60% of maximum HR reached at the end of 6MWT, 3 maximal voluntary isometric contractions (MVC) were made, separated by 5 min rest intervals	5 secondes
Secondary	Quality of life questionnaire (VQ 11)	The VQ11 is a reliable and valid measure of COPD-specific health related quality of life (HRQoL) [27]. The 11 items cover three main components: functional (dyspnea, fatigue and mobility), psychological (physical confidence, anxiety, depression and sleep), and social (life project, social life, closeness and emotional life). A high total score indicates a poor HRQoL	10 min