Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05015777 |
| Other study ID # |
1/16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 6, 2016 |
| Est. completion date |
June 20, 2016 |
Study information
| Verified date |
August 2021 |
| Source |
Poznan University of Physical Education |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study investigated the effect of exercise using the Emil Jaques-Dalcroze's method on the
postural stability of women over 65 years of age. The study model was based on a randomized
controlled trial - parallel group design.
Description:
Participants were recruited through advertisements in local newspapers and on the Internet,
and covered the Poznań Metropolitan Area, Poland. Following randomization using the computer
program Statistica 13.4 (TIBCO Software Inc., Palo Alto, CA)., the participants were divided
into two groups: Intervention Group (IG) and Control Group (CG). The participants' postural
stability was investigated by determining their ability to control the displacement of the
body's center of pressure (COP). For this purpose, the Balance Platform model AccuSway Plus
was used, together with the Balance Trainer software. The system recorded changes in COP
position in the anteroposterior (AP) and mediolateral (ML) directions. The sampling rate was
set at 100 Hz. The COP is a reliable parameter for evaluating postural stability and upright
balance control. The results of the four COP parameters described below were statistically
analysed.
1. COP Path Length: sum of path lengths from the Subject Start Position to the intersection
of the active target perimeter.
2. COP Area Deviation: sum of areas where the COP path deviates from the straight line that
intersects the Subject Start and End Positions.
3. COP Total Time: time taken to complete the entire trial.
4. COP Reaction Time: average reaction time to cross the perimeter of target, measured from
the activation of the next target.
Two measurement sessions were held: the first (baseline) took place during the week before
starting the exercise programme and the second (12-week follow-up) straight after its finish.
Women with IG participated in the exercise programme, while women with CG were advised not to
change anything about their current lifestyle, and in particular not to undertake any new
structured physical activity. Those conducting the measurements were unaware of the purpose
of this study and the fact that the participants were divided into groups.
Training programme. Training sessions took place twice a week for 45 minutes each over a
period of 12 weeks. Each training included rhythmic exercises using the Jaques-Dalcroze
Eurhythmics (JDE) method with piano accompaniment and electronically played music. Training
sessions were conducted by a JDE specialist.
Balance Platform Test Participants had to perform a movement task while standing on a
posturographic platform. A Feedback Balance Analysis protocol was used - the subjects saw a
point on the screen that was a reflection of their COP. By tilting their body in different
directions, they could observe changes in the position of their COP in real time. The
participants' task was to do it in such a way as to direct their COP to the appropriate
targets marked on the screen, in the right order.
Taking into account the natural heterogeneity of the group in terms of physical fitness due
to the age of subjects, the distances of extreme areas in relation to the central area, and
thus the range of deflection, were decided to be determined for each participant
individually. For this purpose, first the maximum deflections of each subject in the AP and
ML directions were determined, and then the software automatically determined the centres of
targets at a distance of 75% of the maximum deflection in a given direction. This ensured
that each subject leaned their torso relatively the same range and that the task was within
their capabilities. The results of maximum torso lean ranges were also statistically
analysed.
The test consisted of two main elements: 1) the COP point movement phase and 2) the COP point
maintain phase. The task consisted of the COP point movement to individual targets (in a
predetermined order), each time the COP point had to be maintained inside the area of each
target for at least one second, after which the target became inactive (darker), which was a
signal of its correct passing. At the same time, the next (active) target would light up,
indicating that the COP point had to be moved to that target, where it again had to be held
for a minimum of one second, and so on. Each time the extreme target was passed, it was
necessary to return to the central target. A similar trial measuring changes in postural
stability in a biofeedback model under the influence of training has already been used in
other experiments.
The posturographic platform was fixed to a flat surface, in front of the subject at a
distance of 1.5 meters at eye level was placed a 27 inch monitor. The room was soundproofed
to ensure peace and quiet. On the platform there were lines specifying the proper distances
and angles of feet placement in order to ensure that the subject stood in the same place
during each subsequent trial. The feet on the platform were placed naturally, one next to the
other at hip width, with the toes gently pointing outwards.
Each participant was given verbal instructions on how to perform the test, with particular
emphasis on the fact that the test had to be carried out as quickly and accurately as
possible, moving the COP point by the shortest possible route to the target, and once
reached, trying to keep the COP point as still as possible in the centre of target until it
became inactive (turned dark). The person conducting the test next performed a demonstration
of the entire trial. The final step was for the subjects to perform two pre-test trials,
followed by a third trial, the results of which were statistically analysed.
Statistical analysis The results of descriptive statistics were presented as means with
standard deviation (mean±SD). Postural stability test results were presented as means and
confidence intervals at the 95% level. A two-factor analysis of variance (ANOVA) was
conducted. An eta square analysis was used to determine effect size. The post-hoc Tukey test
was conducted in case of significant main or interaction effects. Differences between groups
in the single study session area and between study sessions in the group area were determined
using the Mann-Whitney U test with correction for continuity. Statistical significance level
was set at 5%. All calculations were carried out using Statistica 13.4 (TIBCO Software Inc.,
Palo Alto, CA).
