Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000247976
Ethics application status
Approved
Date submitted
6/10/2019
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of various physical trainings to reduce the risk of falls in people aged 65+
Scientific title
Assessment of the impact of physical training including body balance exercises and strength and circulatory endurance exercises on risk factors for falls in people aged 65+. Randomized clinical trial.
Secondary ID [1] 299487 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of falls 314715 0
Advanced age people 314716 0
Postural control disorders 314718 0
Gait disturbance 314719 0
Weakness of endurance 314720 0
Condition category
Condition code
Neurological 313053 313053 0 0
Other neurological disorders
Neurological 313822 313822 0 0
Other neurological disorders
Injuries and Accidents 313823 313823 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this clinical trial is to gain knowledge about the impact of physical training, including body balance exercises, and strength and cardiovascular endurance exercises, on the risk of falls in people aged 65+.

Two experimental groups will be created. In both groups, body balance exercises will be used according to the same program, and in addition, in the experimental group 1 (EG1), exercises aimed at increasing strength endurance will be conducted, and in the experimental group 2 (EG2), exercises aimed at increasing circulatory endurance will be conducted. In both groups, exercises will be applied twice a week for 60 minutes a day, for 12 weeks. In addition, a control group will be created in which patients will not undertake physical training for 12 weeks.

In both experimental groups, physical exercises will be programmed and conducted by a physiotherapist in cooperation with doctors in the field of orthopedics, neurolgia and internal diseases as well as a specialist in the field of medical physiology.

Demographic information on the patients will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the patients and the documentation of their concomitant diseases.

Patients in all groups will be assessed for intellectual performance, daily functioning, quality of life, severity of joint pain, depressive symptoms, fear of falling and level of physical activity before and after the study. These studies will be conducted using appropriate questionnaires.
All patients will also be tested for functional and dynamic body balance, gait quality, aerobic endurance, torso and lower limb muscle strength, grip strength and proprioception of the lower limbs. Patients will also be interviewed regarding the medicines they are taking in cooperation with the clinical pharmacist.

Experimental group 1 (EG1)
In EG1, physical exercise will be conducted for 12 weeks 2 times a week for 60 minutes a day. Exercises aimed at improving static and dynamic body balance will be applied for 30 minutes, and over the next 30 minutes, resistance exercises of the trunk and lower limbs muscles will be conducted to increase strength endurance. Feedback based on virtual reality will be used in all exercises. Body balance exercises will be peformed on platforms with stable and unstable ground. Dynamic resistance exercises with progressively increasing resistance in the range of 20 to 35% of maximum voluntary contraction will be applied in resistance training. Exercises for flexion, extension, rotation and lateral flexion of the trunk in the lumbar and thoracic sections, as well as exercises for flexion and extension of the knee joints will be used.
Virtual reality (VR) will be used to provide feedback. During the exercises, the patient will see virtual images displayed on the monitor screen and his task will be to perform specific body movements to direct the avatar's movements. The patient will be forced e.g. to bypass virtual obstacles, move virtual objects, aiming at virtual objects, etc. These tasks will require the patient to, e.g. transfer weight to the right or left limb, fingers or heels, as well as bend and straighten limbs or torso, etc..

Experimental group 2 (EG2)
In EG2, as in the EG1 group, trainings will be conducted for 12 weeks, twice a week for 60 minutes a day. Within 30 minutes, body balance exercises will be conducted according to the same program as in the EG1 group. In addition, endurance training on a treadmill will be used for EG2 for 30 minutes. The intensity of endurance training will be maintained at 50-60% of the patient's maximum heart rate.
Intervention code [1] 315737 0
Rehabilitation
Intervention code [2] 315738 0
Treatment: Devices
Intervention code [3] 315739 0
Treatment: Other
Comparator / control treatment
Patients in the control group will not receive physical training for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 321604 0
Static body balance assessed on the stabilometric platform in a free posture with eyes open. The assessment will take into account, inter alia, the path length and the area of movement of the COP (center of foot pressure).
Timepoint [1] 321604 0
At baseline, week 12
Primary outcome [2] 321605 0
Dynamic body balance assessed on the stabilometric platform during the test requiring the patient to intentionally and controlled movement of the center of body gravity in different directions. The assessment will take into account, inter alia, the path length and the area of movement of the COP.
Timepoint [2] 321605 0
At baseline, week 12
Primary outcome [3] 321606 0
Quality of gait - a composite primary outcome.
The assessment will be carried out on a treadmill.
A comprehensive assessment of gait quality will be made including: length and width of the steps, duration of the support and swing phases, number of steps per minute (cadence) and gait speed.
Timepoint [3] 321606 0
At beaseline, week 12
Secondary outcome [1] 375566 0
Oxygen endurance assessed based on the distance traveled in a 6-minute walk test (6MWT).
Timepoint [1] 375566 0
At baseline, week 12
Secondary outcome [2] 375567 0
Quality of life assessed with Euro – Quality of Life Questionnaire.
Timepoint [2] 375567 0
At baseline, week 12
Secondary outcome [3] 377777 0
Knee flexor muscle strength in isokinetic conditions at an angular velocity of 120 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full extension in the knee joint. The patient's lower leg will be attached to an arm moving at a constant angular velocity of 120 degrees per minute. At this angular velocity, the patient's task will be to bend the knee joint three times with maximum strength.
Timepoint [3] 377777 0
At baseline and week 12
Secondary outcome [4] 377778 0
Knee extensor muscle strength in isokinetic conditions. At an angular speed of 120 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full knee flexion. The patient's lower leg will be attached to an arm moving at a constant angular velocity of 120 degrees per minute. At this angular velocity, the patient's task will be to extend the knee joint three times with maximum strength.
Timepoint [4] 377778 0
At baseline and week 12
Secondary outcome [5] 377779 0
Knee flexor muscle strength in isokinetic conditions at an angular velocity of 60 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full extension in the knee joint. The patient's lower leg will be attached to an arm moving at a constant angular velocity of 60 degrees per minute. At this angular velocity, the patient's task will be to bend the knee joint three times with maximum strength.
Timepoint [5] 377779 0
At baseline and week 12
Secondary outcome [6] 377780 0
Knee extensor muscle strength in isokinetic conditions. At an angular speed of 60 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full knee flexion. The patient's lower leg will be attached to an arm moving at a constant angular velocity of 60 degrees per minute. At this angular velocity, the patient's task will be to extend the knee joint three times with maximum strength.
Timepoint [6] 377780 0
At baseline and week 12
Secondary outcome [7] 377781 0
Ankle flexor force in isokinetic conditions at an angular velocity of 120 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full extension in the ankle. The patient's foot will be attached to an arm moving at a constant angular velocity of 120 degrees per minute. At this angular velocity, the patient's task will be to perform three times flexion in the ankle joint with maximum strength.
Timepoint [7] 377781 0
At baseline and week 12
Secondary outcome [8] 377782 0
Ankle extensor force in isokinetic conditions at an angular velocity of 120 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full flexion at the ankle. The patient's foot will be attached to an arm moving at a constant angular velocity of 120 degrees per minute. At this angular velocity, the patient's task will be to extend the ankle joint three times with maximum strength.
Timepoint [8] 377782 0
At baseline and week 12
Secondary outcome [9] 377783 0
Ankle flexor force in isokinetic conditions at an angular velocity of 60 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full extension in the ankle. The patient's foot will be attached to an arm moving at a constant angular velocity of 60 degrees per minute. At this angular velocity, the patient's task will be to perform three times flexion in the ankle joint with maximum strength.
Timepoint [9] 377783 0
At baseline and week 12
Secondary outcome [10] 377784 0
Ankle extensor force in isokinetic conditions at an angular velocity of 60 degrees per minute.

During the examination, the patient will sit in an armchair designed for isokinetic testing. The starting position will be full flexion at the ankle. The patient's foot will be attached to an arm moving at a constant angular velocity of 60 degrees per minute. At this angular velocity, the patient's task will be to extend the ankle joint three times with maximum strength.
Timepoint [10] 377784 0
At baseline and week 12
Secondary outcome [11] 377785 0
Strength of torso extensors in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be bending your torso forward to 90 degrees. The patient's task will be to stretch the torso three times against the resistance dosed at the height of the shoulder blade and maintain the maximum isometric contraction of muscles for 5 seconds.
Timepoint [11] 377785 0
At baseline and week 12
Secondary outcome [12] 377786 0
Torso flexor strength in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be extension of the torso. The patient's task will be to bend the torso three times against the resistance dosed at the front, at the height of the upper chest and maintain the maximum isometric muscle contraction for 5 seconds.
Timepoint [12] 377786 0
At baseline and week 12
Secondary outcome [13] 377787 0
Torso lateral flexion force to the right in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be the lateral flexion of the torso to the left to an angle of 20 degrees. The patient's task will be to bend the torso three times to the right against the resistance dosed from the right side, at the height of the upper chest and maintain the maximum isometric muscle contraction for 5 seconds.
Timepoint [13] 377787 0
At baseline and week 12
Secondary outcome [14] 377788 0
Strength of lateral flexion of the torso to the left, in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be the lateral flexion of the torso to the right to an angle of 20 degrees. The patient's task will be to bend the trunk three times to the left against the resistance dosed from the left side, at the height of the upper chest and maintain the maximum isometric muscle contraction for 5 seconds.
Timepoint [14] 377788 0
At baseline and week 12
Secondary outcome [15] 377789 0
Torso rotator force to the right in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be the rotation of the torso to the left to an angle of 20 degrees. The patient's task will be to rotate the torso left three times against the resistance dosed on the right side and to maintain the maximum isometric contraction of muscles for 5 seconds.
Timepoint [15] 377789 0
At baseline and week 12
Secondary outcome [16] 377790 0
Torso rotator force to the left in isometric conditions.

During the examination, the patient will sit in a chair designed for isometric testing of the torso. The starting position will be the rotation of the torso to the right to an angle of 20 degrees. The patient's task will be to rotate the torso left three times against the resistance dosed on the left side and to maintain the maximum isometric contraction of muscles for 5 seconds.
Timepoint [16] 377790 0
At baseline and week 12

Eligibility
Key inclusion criteria
Patient eligibility for the experiment will be established by their physician as per the following criteria: 1) age from 65 to 85 years, 2) consent to participate in the research, 3) the result of the assessment of independence in everyday life according to the Barthel scale above 20 points, 4) the ability to move independently, 5) ability to understand and follow therapist's instructions.
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Contraindications to physical training provided for in the study (including circulatory-respiratory failure, chronic heart failure, acute injuries and inflammation of the musculoskeletal system, lower limb endoprostheses less than 6 months after surgery); 2) Muscle and nervous system diseases affecting body balance disturbing body balance; 3) Eye defects uncorrected with glasses or contact lenses; 4) Rheumatoid diseases; 5) Imbalance resulting from ear, eye, and head and neck blood vessels.

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)
The selected patients who will give their consent to participate in the study will be randomly assigned to the control group (no physical training for 12 weeks), the experimental group 1 (balance and strength endurance training) or the experimental group 2 (balance, and cardiovascular endurance training) using a concealed process.

In order to allocation concealment for individual groups, random permuted blocks will be used. Six-digit blocks will be created (1 - first experimental group; 2 - second experimental group; 3 - control group). In each block the number of digits will be the same and their order will be randomly generated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient allocation to groups will be independent of when and who will deliver the treatment. The group allocation sequence will be concealed. Block randomization will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
After the experiment, patient’s characteristics will be tested for normality of distribution using the Shapiro-Wilk test. In the case of normal distribution, the parametric ANOVA test will be used, and in the case of non-normal distributions, the non-parametric tests (Kruskal-Wallis analysis of variance for inter-group comparisions and Friedman’s ANOVA for intragroup comparisions) will be used to establish statistical significance.

Patients’ characteristics will also be tested for skewness, kurtosis and modality of distributions. In the cases when skewness and kurtosis are smaller than 4 and the distributions are unimodal, arithmetic averages and standard deviations will be used as the measures of central value and dispersion.

The level of statistical significance in all tests will be p < 0.05.

The statistical analysis will be performed using the Statistica software by StatSoft (licenced to the Medical University of Silesia).

In each group, changes in static and dynamic balance, gait quality, aerobic endurance, muscular strength and quality of life after treatment will be assessed against pre-treatment conditions. The results will also be compared between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2020
Actual
Date of last participant enrolment
Anticipated
3/08/2020
Actual
Date of last data collection
Anticipated
2/11/2020
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 21908 0
Poland
State/province [1] 21908 0
Silesia

Funding & Sponsors
Funding source category [1] 303982 0
University
Name [1] 303982 0
Academy of Physical Education in Katowice, Poland
Country [1] 303982 0
Poland
Primary sponsor type
University
Name
Academy of Physical Education
Address
Mikolowska 72A str. 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 304154 0
None
Name [1] 304154 0
Address [1] 304154 0
Country [1] 304154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304480 0
The Research Ethics Commitee from the Academy of Physical Education in Katowice, Poland
Ethics committee address [1] 304480 0
Ethics committee country [1] 304480 0
Poland
Date submitted for ethics approval [1] 304480 0
04/10/2018
Approval date [1] 304480 0
15/11/2018
Ethics approval number [1] 304480 0
1/2018

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

Contacts
Principal investigator
Name 97094 0
Prof Anna Polak
Address 97094 0
Prof. Anna Polak. PT, PhD
Institute of Physioterapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A Str. 40-062 Katowice. Poland
Country 97094 0
Poland
Phone 97094 0
+48322075301
Fax 97094 0
+48322075301
Email 97094 0
[email protected]
Contact person for public queries
Name 97095 0
Anna Polak
Address 97095 0
Prof. Anna Polak. PT, PhD
Institute of Physioterapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A Str. 40-062 Katowice. Poland
Country 97095 0
Poland
Phone 97095 0
+48322075301
Fax 97095 0
+48322075301
Email 97095 0
[email protected]
Contact person for scientific queries
Name 97096 0
Anna Polak
Address 97096 0
Prof. Anna Polak. PT, PhD
Institute of Physioterapy and Health Sciences, The Jerzy Kukuczka Academy of Physical Education, Mikolowska 72A Str. 40-062 Katowice. Poland
Country 97096 0
Poland
Phone 97096 0
+48322075301
Fax 97096 0
+48322075301
Email 97096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.