Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000627550
Ethics application status
Approved
Date submitted
2/05/2015
Date registered
16/06/2015
Date last updated
16/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between body balance, lung function, nutritional status and functional capacity in male patients with Chronic Obstructive Pulmonary Disease
Scientific title
Relationship between body balance, lung function, nutritional status and functional capacity in male patients with Chronic Obstructive Pulmonary Disease
Secondary ID [1] 286628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
copd 294946 0
Condition category
Condition code
Respiratory 295206 295206 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This was a observational study in which adults with COPD underwent pulmonary function testing (plethysmography), 6-min walking test (6MWT), and nutritional status assessment using Mini Nutritional Assessment (MNA). Body balance was quantified using Timed UP and GO test, BBS scale, Tinetti test and Unipodal Stance Test (UST). participants completed each test over 1 hour at baseline and again after 1 month
Duration: 1 months
Intervention code [1] 291763 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294964 0
composite primary outcome: body balance assessed using TUG test, tinetti test, BBS, UST and ABC scale
Timepoint [1] 294964 0
one assessement for each test at baseline and after 1 month.
Secondary outcome [1] 314476 0
exercise capacity assessed using the 6 Minute Walk Test at baseline.
Timepoint [1] 314476 0
one assessement for this outcome at baseline and after 1 month..
Secondary outcome [2] 314660 0
nutritional status was assessed using MNA scale
Timepoint [2] 314660 0
one assessement for this outcome at baseline and after 1 month..
Secondary outcome [3] 314661 0
pulmonary function was assessed using plethysmography
Timepoint [3] 314661 0
one assessement at baseline and after 1 month..

Eligibility
Key inclusion criteria
A convenience sample of adults males with COPD was recruited for participating. The inclusion criteria for people with COPD was the presence of moderate to severe disease (stage II or III) diagnosed by a physician on the basis of the Global Initiative for Obstructive Lung Disease
Minimum age
45 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1) known cognitive impairment; (2) mechanical ventilation for all or part of the day; (3) neurological or musculoskeletal condition that limited mobility; and (4) symptomatic cardiovascular disease.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
The sample size was calculated using MedCalc version
8.2 (Medcalc Software, Mariakerke, Belgium). A minimum
of 23 cases were required to test for the alternative hypothesis
that the correlation coefficient is higher than 0.50.
To check the normality of the sample, a Shapiro-Wilk test was used. Independent t test was used to examine differences between patients with low score and patients with normal score of each balance test. Spearman's correlation analysis was used to test the possible correlations between the parameters. The statistical significance level was set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2015
Actual
13/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 6859 0
Tunisia
State/province [1] 6859 0
sousse

Funding & Sponsors
Funding source category [1] 291201 0
Hospital
Name [1] 291201 0
Farhat Hached Hospital of Sousse of TUNISIA
Country [1] 291201 0
Tunisia
Funding source category [2] 291202 0
University
Name [2] 291202 0
University of Sousse - TUNISIA-
Country [2] 291202 0
Tunisia
Primary sponsor type
University
Name
Faculty of medecine of sousse - University of sousse
Address
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country
Tunisia
Secondary sponsor category [1] 289879 0
Hospital
Name [1] 289879 0
Farhat Hached Hospital of Sousse of TUNISIA
Address [1] 289879 0
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country [1] 289879 0
Tunisia
Secondary sponsor category [2] 289882 0
Individual
Name [2] 289882 0
mkacher wajdi
Address [2] 289882 0
Mkacher Wajdi. Departement of lung function. Farhat Hached Hospital. Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country [2] 289882 0
Tunisia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56922 0
Dr mkacher wajdi
Address 56922 0
FACULTY OF MEDECINE OF SOUSSE. University of Sousse
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 56922 0
Tunisia
Phone 56922 0
+21622875172
Fax 56922 0
Email 56922 0
[email protected]
Contact person for public queries
Name 56923 0
mkacher wajdi
Address 56923 0
FACULTY OF MEDECINE OF SOUSSE. University of Sousse
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 56923 0
Tunisia
Phone 56923 0
+21622875172
Fax 56923 0
Email 56923 0
[email protected]
Contact person for scientific queries
Name 56924 0
mkacher wajdi
Address 56924 0
FACULTY OF MEDECINE OF SOUSSE. University of Sousse
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 56924 0
Tunisia
Phone 56924 0
+21622875172
Fax 56924 0
Email 56924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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