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

NCT03604952 | Completed

• 1 other identifier: Faculty of Medicine of Sousse,
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Keywords

chronic obstructive pulmonary disease; Ramadan observance; pulmonary variables; postural balance; exercise performance

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Isometric leg force assessment

  5 secondes

• Quality of life questionnaire (VQ 11)

  10 min

Interventions

COPD patients DIAGNOSTIC_TEST

Tests performed one week before Ramadan (C), and during the second (R-2) and the fourth weeks of Ramadan (R-4)

Eligibility Criteria

• Age: 67 Years - 77 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants in this study were 20 male volunteers with COPD

You may qualify if:

• medication remained unchanged during Ramadan).Smokers

You may not qualify if:

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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Study Sites (1)

Faculty of Medicine of Sousse

Sousse, 4002, Tunisia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Avenue Mohamed Karoui, 4002, Sousse, Tunisia

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: July 30, 2018
• Study Start: June 18, 2015
• Primary Completion: July 14, 2015
• Study Completion: July 16, 2015
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)