Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000373673
Ethics application status
Approved
Date submitted
26/03/2014
Date registered
8/04/2014
Date last updated
12/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of exercise training on patients with schizophrenia
Scientific title
Effects of an 8 month exercise training intervention on physical function and quality of life of patients with schizophrenia
Secondary ID [1] 284340 0
None
Universal Trial Number (UTN)
U1111-1154-9193
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 291496 0
Condition category
Condition code
Mental Health 291863 291863 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty one sedentary patients with schizophrenia were randomly assigned by simple random allocation (drawing lots) to a dance group (group A; 16 patients), who participated in a traditional dancing exercing program which was administered by a dance teacher, or to a control group (group B; 15 patients). The dancing exercise program was specifically
designed to meet the abilities of patients with schizophrenia, jointly by a physical education teacher,
who was a professional experienced dance instructor
and had extensive experience in fitness, dancing
and rehabilitation. Allocation sequence was concealed until intervention was assigned. Patients were recruited from a psychiatric outpatient department of AHEPA hospital, in where they were staying enclosed.
The eight-month supervised training program was carried out in the psychiatric outpatient department, where the patients were staying, three times a week. The warm-up period lasted 10 min and included stretching. The dance phase lasted 40 min and consisted of basic, low impact steps, performed in a single group while holding hands in a hemi-cycle. The exercise program was ending with a cool-down phase that lasted 10 minutes. The dances were practiced in a progressive order from the simplest and least physically demanding to the most complex and dynamic, in terms of movement elements. All dances were circle dances, starting with the right foot moving counter-clock-wise and were accompanied by traditional Greek music from different areas of Greece.
The steps of the selected Greek dances were simple, such as stepping to the side, followed by a closing of the foot together or a passing of the foot in front or behind the other, single limb standing, hopping, jumping and trunk extension. The duration of each dance was 3-4 min and the breaks between dances lasted 15 s.
At the beginning of the program, the intensity of the dances was low and increased progressively aiming to become moderate to high after week 16. The instructors ensured that the training intensity was set at an aerobic endurance level of 60–70 % of individual maximum heart rate, which was calculated individually for each participant using the ‘220-age’ formula. Heart rate of each participant was measured by instructors every 10 min during the training sessions. The patients were allowed to stop exercising whenever they felt uncomfortable.The attendance was calculated by the teacher who monitored attendance records
Intervention code [1] 289064 0
Lifestyle
Comparator / control treatment
Active control.15 schizophrenic patients who refrained from any kind of physical activity and followed a sedentary lifestyle, constituted the control group
Control group
Active

Outcomes
Primary outcome [1] 291787 0
the results of this study suggest that training with Greek traditional dances improves functional capacity in patients with schizophrenia. The following functional capacity tests were performed on all subjects:
i) Six-min walk test (6MWT): the 6-min walking test was used to estimate the physical function of the subjects. Participants completed a 6-min endurance walk test, walking as comfortably as possible in 6 min. The 6-min test is a useful measure of functional capacity, targeting people with at least moderately severe impairment.
ii) sit-to-stand test (STS): subjects were asked to rise as fast as possible, with their arms folded, from a chair with a seat level of 0.42 above the floor. The subjects were required to rise ten times consecutively and the time taken to complete the task was recorded. The STS test is used as an indicator for lower limb strength, balance and mobility. It has been reported that the STS times are associated with standing and leaning balance and mobility in older people. Slow STS times have been also found to predict subsequent disability, falls and hip fractures.
iii) Berg Balance Scale (BBS): BBS evaluates the performance in specific activities that require balance function. The BBS is a 14-item functional test involving common actions (e.g. sit to stand, picking up an object, standing on one leg e.t.c.) necessary for activities of daily living. Participants were scored on a 5-point (0-4) ordinal scale depending on their ability to complete the requested actions. A score of 0 was assigned when the task could not be completed and a score of 4 indicated independence. A score of 45 or less is used by the most investigators to indicate a greater risk for falls.
iv) Low limbs strength testing: Baseline Leg Dynamometer was used to assess patients’ lower limbs strength. Firstly, there was a familiarization with the method and patients were asked to make two test trials. Thereafter the best of the three trials was recorded.
v) Hand-Grip strength: Hand-grip strength was assessed in both sides, using a baseline handheld dynamometer. The participants were seated with the forearm in neutral position and the elbow at 90 degrees. They squeezed the handgrip as hard as they could. The best of the three measurements was used for further analysis.
Timepoint [1] 291787 0
8 months
Secondary outcome [1] 307539 0
The results of this study revealed that exercise training with Greek traditional dances is capable to improve Quality of Life in patients with schizophrenia. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) was used in order to evaluate the QoL of the participants. The Q-LES-Q is a self-report measure designed to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The Q-LES-Q is composed of 93 items, with 91 of them grouped into six summary subscales reflecting satisfaction with physical health, subjective feelings, leisure activities, household duties, social relationships, and general activities. High scores on the Q-LES-Q indicate greater enjoyment or satisfaction.
Timepoint [1] 307539 0
8 months
Secondary outcome [2] 307597 0
Global Assessment of Functioning Scale (GAF) was used to evaluate the patients social and occupational functioning
Timepoint [2] 307597 0
8 months
Secondary outcome [3] 307598 0
Positive and Negative Syndrome Scale (PANSS) was also used for measuring the patient’s symptoms severity.
Timepoint [3] 307598 0
8 months

Eligibility
Key inclusion criteria
All participants needed to have a diagnosis of schizophrenia to be eligible for this study. Also, the inclusion criteria were:
1.participants were taking stable doses of antipsychotic medication for at least six weeks prior to inclusion.
2. Patients were asked to refrain from any other form of organized physical activity during the study period
3.The partcipants required to fulfill the 70% attendance during the training programs.
4.Also, another basic precondition for the participation in the study was mini mental score greater or equal to 22.
Minimum age
46 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they: i) had significant cardiovascular, neuromuscular and endocrine or other somatic disorder that may prevent safe participation in the study (IOC Medical Commission, 2004), ii) were judged by the attending psychiatrics to be too unwell to participate in the exercise program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Thirty one sedentary patients with schizophrenia were randomly assigned by simple random allocation (drawing lots) to a dance group or to a control group. The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
no
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were analysed with Statistical Package for Social Sciences (SPSS, Chicago, Illinois, USA), version 20.0 software for windows.The number of participants needed to achieve study objectives was determined with G*power analysis.The sample size was calculated on the basis of the primary hypothesis.Because of the rarity of the disease, the sample
size was limited. According to Gpower analysis we needed twelve people to test the hypothesis at significance level .05 and power 0.8. Also,in sample size planning we
consider losses to follow-up or drop-outs, therefore the sample size was proportionately increased. We increased the sample further to sixteen and the power was 0.9.
The Kolmogorov-Smirnov test was used to examine the normality of the distribution. Changes of variables within the groups at baseline and the end of the study were evaluated by Two-Way ANOVA with repeated measures of variance with time and group being the independent variables. In addition, within-group change from baseline was obtained by subtracting the final from the baseline values. A one-way ANOVA followed by Bonferroni post hoc test was used for between-group comparisons of change from baseline. Furthermore, the relationships of the differences from the final to the baseline measurement of the above parameters were observed using Pearson’s correlation coefficient. Moreover, multiple regression analysis was also performed, to examine the factors that affect QLS and functional capacity, using the Total score of the Q-LES-Q and 6MWT as subordinate variables. Data are expressed as mean +/-SD, with a significance level p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 5930 0
Greece
State/province [1] 5930 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 288980 0
University
Name [1] 288980 0
Aristotle University
Country [1] 288980 0
Greece
Primary sponsor type
University
Name
Aristotle University of Thessaloniki
Address
TEFAA, Sportmedicine Laboratory
Thermi PC 54100
Thessaloniki
Country
Greece
Secondary sponsor category [1] 287659 0
Individual
Name [1] 287659 0
Antonia Kaltsatou
Address [1] 287659 0
Physical Education and Sport Science Department of Aristotle University of Thessaloniki
Thermi PC 54100
Thessaloniki, Greece
Country [1] 287659 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290791 0
Ethical Committee of the Aristotle University
Ethics committee address [1] 290791 0
Ethics committee country [1] 290791 0
Greece
Date submitted for ethics approval [1] 290791 0
20/08/2012
Approval date [1] 290791 0
01/09/2012
Ethics approval number [1] 290791 0

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

Contacts
Principal investigator
Name 47262 0
Dr Antonia Kaltsatou
Address 47262 0
Sportsmedicine Laboratory, Aristotle University of Thessaloniki
22, Dim. Gounari Str
54621, Thessaloniki
Greece
Country 47262 0
Greece
Phone 47262 0
+306938767967
Fax 47262 0
Email 47262 0
[email protected]
Contact person for public queries
Name 47263 0
Antonia Kaltsatou
Address 47263 0
Sportsmedicine Laboratory, Aristotle University of Thessaloniki
22, Dim. Gounari Str
54621, Thessaloniki
Greece
Country 47263 0
Greece
Phone 47263 0
+302310263562
Fax 47263 0
Email 47263 0
[email protected]
Contact person for scientific queries
Name 47264 0
Antonia Kaltsatou
Address 47264 0
Sportsmedicine Laboratory, Aristotle University of Thessaloniki
22, Dim. Gounari Str
54621, Thessaloniki
Greece
Country 47264 0
Greece
Phone 47264 0
+306938767967
Fax 47264 0
Email 47264 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
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