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

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

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).

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: COPD patients

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Tunisia
  • Sousse, Tunisia, 4002
    • Faculty of Medicine of Sousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 67 years to 77 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Participants in this study were 20 male volunteers with COPD

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Faculty of Medicine, Sousse

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2015
• Primary Completion (Actual): July 14, 2015
• Study Completion (Actual): July 16, 2015

Study Registration Dates

• First Submitted: July 21, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 21, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: postural balance; chronic obstructive pulmonary disease; exercise performance; Ramadan observance; pulmonary variables
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Faculty of Medicine of Sousse,

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No