Condition category
Not Applicable
Date applied
03/06/2020
Date assigned
19/06/2020
Last edited
19/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Sufficient postural control is important to succeed in activities of daily living such as standing (static balance), walking (dynamic balance), or in situations where balance is particularly challenged to avoid a fall as for instance when leaning forward while reaching (proactive balance). Regular balance training knowingly improves these measures of balance performance. However, balance training can include exercises of various task difficulties. For example, a one-legged stance may represent a rather simple task as long as it is executed on firm ground with eyes opened, but pose a higher challenge to an individual once it is executed on unstable ground and/or with eyes closed. Thus, it is assumed that the effectiveness of balance training is affected by the difficulty of the exercises performed. Therefore, this study aims to investigate whether conducting balance training with a high level of task difficulty (BT-high) is more effective than a comparable training with a low level of task difficulty (BT-low) in healthy male adolescents.

Who can participate?
Healthy male adolescents aged 10-15

What does the study involve?
Participants are randomly allocated to one of two groups who both receive a standardized balance training (BT) program for 7 weeks (two sessions per week, 30-35 minutes each). One group (BT-low) performs balance exercises with a low level of task difficulty while the other group (BT-high) conducts balance exercises with a high level of task difficulty. The balance exercises performed during each training session will be similar in nature in both groups. However, exercises in the BT-high group will be performed under more challenging conditions. For example, the BT-low group will perform squats in two-legged stance with eyes opened, whereas the BT-high group conducts the same exercise with eyes closed. Other methods to influence task difficulty will be to allow (BT-low) or prohibit (BT-high) arm support and to exclude (BT-low) or include (BT-high) additional motor (e.g., throwing and catching a ball) and cognitive (e.g., counting backwards) tasks during the exercise. Before and after 7 weeks of balance training balance performance is assessed under static (i.e., time in balance during one-legged stance), dynamic (i.e., gait velocity during normal walking), and proactive (i.e. reach distance in the Y-balance test; time to complete the timed-up-and-go test) conditions to find out whether both types of training are effective at improving balance performance and whether one training regime is more effective than the other.

What are the possible benefits and risks of participating?
The benefits include improved physical performance and especially balance performance. These may be associated with increased health as well as with a reduced risk of an injury or a fall. Besides temporary fatigue following the training sessions, there are no risks associated with the participation in the study.

Where is the study run from?
University of Duisburg-Essen (Germany)

When is the study starting and how long is it expected to run for?
April 2018 to April 2019

Who is funding the study?
University of Duisburg-Essen (Germany)

Who is the main contact?
Prof. Thomas Muehlbauer
thomas.muehlbauer@uni-due.de

Trial website

Contact information

Type

Scientific

Primary contact

Mr Simon Schedler

ORCID ID

Contact details

Gladbecker Str. 182
Essen
45141
Germany
+492011837350
simon.schedler@uni-due.de

Type

Scientific

Additional contact

Prof Thomas Muehlbauer

ORCID ID

Contact details

Gladbecker Str. 182
Essen
45141
Germany
+492011837333
thomas.muehlbauer@uni-due.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

BT2020a

Study information

Scientific title

Effects of balance training on balance performance in youth: role of training difficulty - a parallel interventional study using a randomized design

Acronym

BTdose

Study hypothesis

Balance training leads to enhanced balance performance in youth. Improvements will be larger following balance training conducted with a high level of task difficulty compared to balance training with a low level of task difficulty.

Ethics approval

Approved 06/12/2018, Human Ethics Committee at the University of Duisburg-Essen, Faculty of Educational Sciences (Universitaetsstr. 2, Essen, 45141, Germany; +49 (0) 201 1837237; ethik-psychologie@uni-due.de), ref: TM_06_12_2018

Study design

Parallel interventional study using a randomized design

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Balance performance

Intervention

Two groups receive a standardized balance training (BT) program for 7 weeks (2 sessions/week, 30-35 minutes each). One group (BT-low) performs balance exercises with a low level of task difficulty while the other group (BT-high) conducts balance exercises with a high level of task difficulty. Participants are randomly assigned to either the BT-low or BT-high group using research randomizer software (www.randomizer.org).

Both groups will conduct a progressive balance training two times per week with single-sessions lasting to about 30-35 minutes for 7 weeks. The balance exercises performed during each training session will be similar in nature in both groups. However, exercises in the BT-high group will be performed under more challenging conditions. For example, the BT-low group will perform squats in two-legged stance with eyes opened, whereas the BT-high group conducts the same exercise with eyes closed. Other methods to influence task difficulty will be to allow (BT-low) or prohibit (BT-high) arm-support and to exclude (BT-low) or include (BT-high) additional motor (e.g., throwing and catching a ball) and cognitive (e.g., counting backwards) tasks during the exercise.

Before and after 7 weeks of balance training balance performance will be assessed under static (i.e., time in balance during one-legged stance), dynamic (i.e., gait velocity during normal walking), and proactive (i.e. reach distance in the Y-balance test; time to complete the timed-up-and-go test) conditions to find out whether both trainings are effective to improve balance performance and whether one training regime is more effective than the other.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Static balance performance is assessed using a one-legged stance (non-dominant leg) under three conditions (1. firm ground, eyes opened; 2. firm ground, eyes closed; 3. foam ground, eyes opened) that are subsequently applied to the participant. The time in balance under each condition is measured to the maximum of 60 s and used for analysis.
2. Dynamic balance is assessed using a 10-m walk test. Participants are given one meter to accelerate and deccelerate before and after the walkway and are asked to walk at their preferred speed. The time to cover the 10 m distance is measured using a standardized stopwatch and subsequently gait velocity is calculated.
3. Proactive balance is measured using the Lower-Quarter Y-Balance Test (YBT). The maximal reach distance in anterior, posteriomedial, and posteriolateral direction is assessed and normalized to leg length. Further, the normalized composite score is calculated.
All outcomes will be measured before and after the 7 weeks intervention period

Secondary outcome measures

Proactive balance assessed using the timed-up-and-go test conducted before and after the 7 weeks intervention period

Overall trial start date

02/04/2018

Overall trial end date

26/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age range: 10-15 years
2: Gender: male
3. Health status: healthy without any known neurological, orthopedic, or musculoskeletal disease

Participant type

Healthy volunteer

Age group

Child

Gender

Male

Target number of participants

40

Total final enrolment

40

Participant exclusion criteria

1. Neurological disease
2. Orthopedic disease/impairment
3. Musculoskeletal disease

Recruitment start date

07/01/2019

Recruitment end date

18/01/2019

Locations

Countries of recruitment

Germany

Trial participating centre

AFC Assindia Cardinals Essen 1983 e.V.
Planckstraße 42
Essen
45147
Germany

Sponsor information

Organisation

University of Duisburg-Essen

Sponsor details

Division of Movement and Training Sciences/Biomechanics of Sport
Gladbecker Str. 182
Essen
45141
Germany
+49 (0)2011837333
thomas.muehlbauer@uni-due.de

Sponsor type

University/education

Website

https://www.uni-due.de/en/

Funders

Funder type

University/education

Funder name

Universität Duisburg-Essen

Alternative name(s)

University of Duisburg-Essen, UDE

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Germany

Results and Publications

Publication and dissemination plan

There is no protocol available for this study. Following post-intervention assessments, data shall be analyzed. The results shall be published through one original research article within 18 months from the end of the study.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Thomas Mühlbauer (thomas.muehlbauer@uni-due.de).

Intention to publish date

26/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/06/2020: Internal review. 04/06/2020: Trial's existence confirmed by Human Ethics Committee at the University of Duisburg-Essen, Faculty of Educational Sciences.