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Trial registered on ANZCTR


Registration number
ACTRN12614000778684
Ethics application status
Approved
Date submitted
12/07/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of balance training enrolled in pulmonary rehabilitation on quality of life, fatigue perception, depression and anxiety in COPD patients.
Scientific title
COPD patients and balance training: effect on quality of life, fatigue, depression and anxiety.
Secondary ID [1] 284970 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 292468 0
Quality of life 292469 0
Fatigue 292470 0
Depression 292471 0
Anxiety 292472 0
Condition category
Condition code
Respiratory 292781 292781 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 292782 292782 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients assigned to the intervention group undergo balance training three times a week for 24 weeks (72 sessions). Training sessions last 30 min and are monitored by health professionals. Participants receive individualized exercises and attention regarding the level of difficulty and approach to training progression. The content of the balance-training program was developed according to previous works , guidelines for fall prevention , and consultation with experts. Balance training consisted of four main types of exercise: (1) stance exercises, (2) transition exercises, (3) gait exercises, and (4) functional strengthening. When a participant was able to complete a task independently and with little instability, the difficulty level was increased progressively by introducing more challenging conditions (eg, eyes closed, addition of a secondary cognitive task, increased speed/repetition, or perturbations). Prior to beginning study, we pilot tested the training program on two patients with COPD to determine (1) equipment needs for safety and (2) feasibility of the balance program with respect to a 30-min session.
Balance training occurred concurrently with inpatient PR, which included (1) supervised exercise training bid three times a week, (2) daily breathing exercises, and (3) self-management education and psychologic and social support. Three times a week, patients in the intervention group receive the balance-training program in place of their usual morning or afternoon exercise session. Therefore, the total time spent exercising is matched between groups.
Intervention code [1] 289800 0
Rehabilitation
Comparator / control treatment
Patients assigned to the control group receive only the usual Pulmonary Rehabilitation program.
it involves setting the intensity of eff ort on a target heart
rate corresponding to 60 -70% of maximum heart rate
reached during the 6-minute walking test. Th is intensity
of training does not lead to excessive symptoms of dyspnea
and fatigue. During the sessions, the subject can
monitor the intensity of training by means of a cardiofrequency
meter (Polar, S810) where alarms are set to
± 5 beats per minute around the target heart rate.
Th e training consists of a 5-minute warm-up followed
by 10 minutes of work (cycling or walking on a
treadmill) and 5 minutes of active recovery, repeated
over a 45-minute session. Th en, the subjects performed
strength exercises (legs and arms) for 30 minutes; the
resistance training included 3 sets per session of each
of the following: seated leg press, seated leg curl, seated
leg extension, standing calf raise, and seated ankle dorsifl
exion. Training intensity was set at 60% of the pretraining
one-repetition maximum for the fi rst 4 weeks
and increased as tolerated thereafter to 80% of the new
one-repetition maximum obtained after 4 weeks of
training, for each exercise. Finally, the session ends with
relaxation exercises and stretching.
Control group
Active

Outcomes
Primary outcome [1] 292633 0
Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20)
Timepoint [1] 292633 0
at baseline and at the end of the 6 months training program
Primary outcome [2] 292634 0
the quality of life was determined using the St. George's Respiratory Questionnaire (SGRQ) in its French version
Timepoint [2] 292634 0
at baseline and at the end of the 6 months training program
Primary outcome [3] 292635 0
Anxiety and depression were measured using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 292635 0
at baseline and at the end of the 6 months training program
Secondary outcome [1] 309387 0
Pulmonary Function using a constant volume plethysmograph (ZAN 500 Body II MeBgrerate ZAN GmbH, Germany)
Timepoint [1] 309387 0
at baseline and at the end of the 6 months training program
Secondary outcome [2] 309388 0
exersise tolerance using the six minutes walk test
Timepoint [2] 309388 0
at baseline and at the end of the 6 months training program

Eligibility
Key inclusion criteria
(1) COPD diagnosed by pulmonary function, (2) stable clinical condition (3), absence of other obstructive disease (asthma, bronchiectasis...) and (4) lack of recent cardiac or neuromuscular pathologies.
Minimum age
45 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who smoke and those who run significant response to bronchodilators, defined as an increase in FEV1 over 12% from predicted values were excluded from our study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 6210 0
Tunisia
State/province [1] 6210 0
Sousse

Funding & Sponsors
Funding source category [1] 289591 0
University
Name [1] 289591 0
University of SOUSSE
Country [1] 289591 0
Tunisia
Primary sponsor type
Hospital
Name
Farhat Hached Hospital
Address
Farhat Hached Hospital, Ibn Jazzar street
4031 SOUSSE EZZOUHOUR SOUSSE
Country
Tunisia
Secondary sponsor category [1] 288275 0
Individual
Name [1] 288275 0
Pr. TABKA Zouhair
Address [1] 288275 0
Faculty of Medecine of sousse, Mohamed Karoui street N° 102, 4002 Sousse
Country [1] 288275 0
Tunisia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291326 0
Research Ethics Committee
Ethics committee address [1] 291326 0
Farhat Hached Hospital, Ibn Jazzar street
4031 SOUSSE EZZOUHOUR SOUSSE
Ethics committee country [1] 291326 0
Tunisia
Date submitted for ethics approval [1] 291326 0
30/11/2013
Approval date [1] 291326 0
30/12/2013
Ethics approval number [1] 291326 0
2013

Summary
Brief summary
Balance impairment in Chronic Obstructive Pulmonary Disease (COPD) is associated with a worsening of quality of life as related with fatigue perception, depression and anxiety. The aim of this study was to examine the effect of balance training included in pulmonary rehabilitation (PR) on quality of life (QOL), fatigue perception, depression and anxiety in COPD patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49902 0
Dr Wajdi Mkacher
Address 49902 0
Department of Physiology, Sousse Faculty of Medicine, Sousse, Tunisia.
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 49902 0
Tunisia
Phone 49902 0
+ 216 22 87 51 72
Fax 49902 0
Email 49902 0
[email protected]
Contact person for public queries
Name 49903 0
Wajdi Mkacher
Address 49903 0
Department of Physiology, Sousse Faculty of Medicine, Sousse, Tunisia.
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 49903 0
Tunisia
Phone 49903 0
+21622875172
Fax 49903 0
Email 49903 0
[email protected]
Contact person for scientific queries
Name 49904 0
Wajdi Mkacher
Address 49904 0
Department of Physiology, Sousse Faculty of Medicine, Sousse, Tunisia.
Ave Mohamed Karoui, 4002, Sousse, Tunisia
Country 49904 0
Tunisia
Phone 49904 0
+ 216 22 87 51 72
Fax 49904 0
Email 49904 0
[email protected]

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