Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000719831
Ethics application status
Approved
Date submitted
5/03/2020
Date registered
9/06/2021
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of physiotherapeutic programme on the balance and functional efficiency of seniors over 75 years of age
Scientific title
The effect of an original physiotherapeutic programme on the balance and functional efficiency of institutionalised seniors over 75 years of age
Secondary ID [1] 300580 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical medicine / rehabilitation 316316 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314582 314582 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Original physiotherapeutic programme, structured as follows:

EACH SESSION IS SUPERVISED BY A LICENSED PHYSIOTHERAPIST.

TEST SESSION I - morning hours - establishing individual eligibility for attending the testing programme - 30 days prior to its commencement
- 30 days since the eligibility screening - commencement of the programme, in the morning - in order to reduce potential for any adverse cardiovascular events, 3 times a week, on the same days, i.e. Mondays, Wednesdays, Fridays
- 120 days since the commencement of the programme - completion of the intervention (i.e. 150 days since the commencement of the study itself)

TEST SESSION II - takes place on the 121st day (i.e. 171 days since Test Session I), spans 2 days, i.e. pursued on Tuesdays and Thursdays, to preclude any inadvertent associations with the exercise regimen, which might otherwise be instrumental in higher muscle tension, and therefore become a confounding factor with regard to the actual effects of the exercise regimen applied

TEST SESSION III - following another 120 days since Test Session II (i.e. 241 days since Test Session I), Test Session III commences - 291 days since Test Session I (plus minus 30 days, as not every patient would be tested upon the first day of eligibility screening), spans two days, i.e. pursued on Tuesdays and Thursdays, to preclude any inadvertent associations with the exercise regimen, which might otherwise be instrumental in higher muscle tension, and therefore become a confounding factor with regard to the actual effects of the long-term observation.

Select implementation details of the study protocol:

Group I (n=30) - Research Group (AB) - a programme of active free exercises and balance exercises (15 min) combined with stimulation through appropriately modulated sounds (15 min).
Group II (n=30) - Research Group (VB) - a programme of free and equivalent active exercises (15 min) combined with visual stimulation (15 min).
Group III (n=30) - Study group (AVB) - a programme of active free exercises and balance exercises (15 min) combined with audio-visual stimulation (15 min).


DESCRIPTION OF THE INTERVENTION

Group I - Study Group (BA) - n=30, i.e. 5 subgroups of 6 persons per 1 physiotherapist. A 16-weeks training, performed 3 times a week. A programme of free and active balance exercises (15 minutes), to be combined with appropriately modulated sound stimulation (15 minutes). Training intensity on an average level, determined against the Borg scale (10-11) 65% HRmax. The sound stimulation to be performed with variable amplitude and intensity alternating every 30 seconds between channels; sound intensity not to exceed 80 dB.
Both assessment and regular monitoring of the participants throughout the project is specifically provided for in the intervention protocol - attendance checklists at each session.

Group II - Study Group (BW) - n=30, i.e. 5 subgroups of 6 persons per 1 physiotherapist. The 16-weeks training, performed 3 times a week. The programme of free and active balance exercises (15 minutes) combined with visual stimulation (15 minutes). Training intensity determined on an average level using the Borg scale (10-11;) 65% HRmax. Visual stimulation is to be provided with the aid of a mobile phone. A game is to be activated for a participant on the phone, making use of a built-in accelerometer. A participant would be expected to move within the AP and ML plane in order to perform a pertinent visual exercise. The game consists in placing a ball into a virtual hole located on the screen.
Both assessment and regular monitoring of the participants throughout the project is specifically provided for in the intervention protocol - attendance checklists at each session.

Group III - Study Group (BAW) - n=30, i.e. 5 subgroups of 6 persons per 1 physiotherapist. A 16-weeks training, performed 3 times a week. Free and active balance exercise programme (15 min), visual and sound stimulation (15 min). Training intensity on an average level, determined against the Borg scale (10-11) 65% HRmax. Visual stimulation will be done with a mobile phone. A game is to be activated for a participant on the phone, making use of a built-in accelerometer. A participant would be expected to move within the AP and ML plane in order to perform a pertinent visual exercise. The game consists in placing a ball into a virtual hole located on the screen.
The sound stimulation to be performed with variable amplitude and intensity alternating every 30 seconds between channels; sound intensity not to exceed 80 dB.
Both assessment and regular monitoring of the participants throughout the project is specifically provided for in the intervention protocol - attendance checklists at each session.

HERE ARE SOME EXAMPLES OF THE EXERCISES PROVIDED FOR IN THE ACTUAL STUDY INTERVENTION PROTOCOL.

EXERCISES - BALANCE-ORIENTED

ONE LEG STAND - HOLD SUPPORT
1. Stand up tall beside the chair
2. Hold on to the back of the chair looking ahead
3. Stand on one leg
4. Try to hold this position for 10 seconds
5. Stand on the other leg
6. Try to hold this position for 10 seconds

ONE LEG STAND - NO SUPPORT
1. Stand on one leg
2. Try to hold this position for 10 seconds
3. Stand on the other leg
4. Try to hold this position for 10 seconds

SIT TO STAND - TWO HANDS
1. Sit on a standard chair
2. Place the feet behind the knees
3. Lean forward over your knees
4. Push off with both hands to stand up
5. Repeat this a few times

SIT TO STAND - NO HANDS
1. Sit on a standard chair
2. Place the feet behind the knees
3. Lean forward over your knees
4. Stand up without using your hands
5. Repeat this a few times

ORIGINAL BALANCE-ORIENTED EXERCISE
A participant would be expected to move within the AP (AP antero-posterio) and ML (ML medio-lateral) plane in order to perform a pertinent visual exercise. The game consists in placing a ball into a virtual hole located on the screen. The sound stimulation to be performed with variable amplitude and intensity alternating every 30 seconds between channels; sound intensity not to exceed 80 dB.

Intervention code [1] 316885 0
Rehabilitation
Intervention code [2] 316887 0
Prevention
Comparator / control treatment
Group IV (n=30) - Control group (C) - a programme of active free exercises and balance exercises, no verbal stimulation (30 min).

Group IV - Control Group (K) - n=30, i.e. 5 subgroups of 6 persons per 1 physiotherapist. The 16-weeks training, performed 3 times a week. The programme consists of free and active balance exercises, with no verbal stimulation, to be performed for 30 minutes. Training intensity on an average level, determined against the Borg scale (10-11) 65% HRmax.
Both assessment and regular monitoring of the participants throughout the project is specifically provided for in the intervention protocol - attendance checklists at each session.
Control group
Active

Outcomes
Primary outcome [1] 323124 0
Primary outcomes
Change in individual balance capacity in seniors, as expressed in SLS <=10 seconds of balance, BBS by >=46 points (clinically significant value) and in stabilometric platform values in AP projection by <=30 cm, and in ML projection by >=15cm.
Timepoint [1] 323124 0
Primary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention, to have the actual study results compared with the ones recorded at baseline, i.e. prior to commencement of the intervention protocol (STUDY I). Each project participant would thus be availed of an opportunity to observe whatever specific changes have occurred in result of the intervention in terms of the variables regarding individual balance.
Subsequently, each participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This would facilitate the comparison of the variables regarding individual balance recorded at baseline with the post-intervention ones, i.e. STUDY I vs STUDY II.
Primary outcome [2] 327613 0
Primary outcomes
Change in individual double-task functional efficiency, as expressed in TUGCOG, to the value of <10.57 seconds.
Timepoint [2] 327613 0
Primary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention. This will make it possible to compare the results yielded by the study with the ones recorded at baseline, i.e. prior to the actual commencement of the intervention protocol (STUDY I). This way, each project participant shall have an opportunity to see for himself what specific changes have occurred in result of the intervention, in terms of the variables under study regarding individual functional efficiency.
Subsequently, each project participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This will make it possible to compare the results recorded at baseline, i.e. prior to the actual commencement of the intervention protocol (STUDY I) and after the intervention protocol has been concluded (STUDY II). This way, each project participant shall have an opportunity to see for himself what specific changes have occurred at 4 months following the conclusion of the intervention, in terms of the variables under study regarding individual functional efficiency.
Secondary outcome [1] 380862 0
Secondary outcomes
Change in Individual double-task functional efficiency, as expressed through the results on the stabilometric platform, i.e. path length value of <=160 mm.
Timepoint [1] 380862 0
Secondary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention. This will make it possible to compare the results yielded by the study with the ones recorded at baseline, i.e. prior to the actual commencement of the intervention protocol (STUDY I). This way, each project participant shall have an opportunity to see for himself what specific changes have occurred in result of the intervention, in terms of the variables under study regarding individual balance and functional efficiency.
Subsequently, each project participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This will make it possible to compare the results recorded at baseline, i.e. prior to the actual commencement of the intervention protocol (STUDY I) and after the intervention protocol has been concluded (STUDY II). This way, each project participant shall have an opportunity to see for himself what specific changes have occurred at 4 months following the conclusion of the intervention, in terms of the variables under study regarding individual balance and functional efficiency.
Secondary outcome [2] 395943 0
Secondary outcomes
Change in Individual The Timed Up and Go (TUGman) test.
Timepoint [2] 395943 0
Secondary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention, to have the actual study results compared with the ones recorded at baseline, i.e. prior to commencement of the intervention protocol (STUDY I). Each project participant would thus be availed of an opportunity to observe whatever specific changes have occurred in result of the intervention in terms of the variables regarding individual functional efficiency.

Subsequently, each participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This would facilitate the comparison of the variables regarding individual functional efficiency recorded at baseline with the post-intervention ones, i.e. STUDY I vs STUDY II.
Secondary outcome [3] 395944 0
Secondary outcomes
Change in Individual Single Leg Stance Open Eyes (SLSOP) test, Single Leg Stance Closed Eyes (SLSCL) test.
Timepoint [3] 395944 0
Secondary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention, to have the actual study results compared with the ones recorded at baseline, i.e. prior to commencement of the intervention protocol (STUDY I). Each project participant would thus be availed of an opportunity to observe whatever specific changes have occurred in result of the intervention in terms of the variables regarding individual balance.

Subsequently, each participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This would facilitate the comparison of the variables regarding individual balance recorded at baseline with the post-intervention ones, i.e. STUDY I vs STUDY II.
Secondary outcome [4] 396318 0
Change in Individual the Trail Making Test part B (TMT-B).
Timepoint [4] 396318 0
Secondary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention, to have the actual study results compared with the ones recorded at baseline, i.e. prior to commencement of the intervention protocol (STUDY I). Each project participant would thus be availed of an opportunity to observe whatever specific changes have occurred in result of the intervention in terms of the variables regarding individual functional efficiency.

Subsequently, each participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This would facilitate the comparison of the variables regarding individual functional efficiency recorded at baseline with the post-intervention ones, i.e. STUDY I vs STUDY II.
Secondary outcome [5] 396319 0
Change in Individual the Tinetti Test (POMA) - Performance Oriented Mobility Assessment Balance and Gait - a scale assessing balance and gait.
Timepoint [5] 396319 0
Secondary timepoints
Each project participant is to be examined between the 1st and the 15th day following the concluded intervention, to have the actual study results compared with the ones recorded at baseline, i.e. prior to commencement of the intervention protocol (STUDY I). Each project participant would thus be availed of an opportunity to observe whatever specific changes have occurred in result of the intervention in terms of the variables regarding individual balance and gait.

Subsequently, each participant is to be examined between the 1st and 15th day, within 4 months of the concluded intervention. This would facilitate the comparison of the variables regarding individual balance and gait recorded at baseline with the post-intervention ones, i.e. STUDY I vs STUDY II.

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

1. Age of participants >=75 years
2. MMSE>=19
3. Blood pressure <140-159 mmHg (systolic) and <90-99 mmHg (diastolic).
4. GS >0.8 m/s
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
EXCLUSION CRITERIA

1. Visual impairment <= 2 dioptres
2. Moderate hearing loss <=40-70 dB
3. Functional limb shortening
4. Alzheimer's disease
5. Parkinson's disease
6. Unstable cardiovascular diseases
7. Active cancer
8. No informed, written consent for attending the study protocol
9. Bouts of dizziness (lasting in excess of 10 minutes/day - over the last 3 weeks)
10. GDS >8 points


Study design
Purpose of the study
Prevention
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
2/03/2021
Date of last data collection
Anticipated
Actual
31/05/2021
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 23742 0
Poland
State/province [1] 23742 0

Funding & Sponsors
Funding source category [1] 305001 0
University
Name [1] 305001 0
The Jan Kochanowski University in Kielce
Country [1] 305001 0
Poland
Primary sponsor type
University
Name
The Jan Kochanowski University in Kielce
Address
ul.. Stefana Zeromskiego 5, 25-369 Kielce,
Country
Poland
Secondary sponsor category [1] 305355 0
None
Name [1] 305355 0
Address [1] 305355 0
Country [1] 305355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305398 0
Bioethics Review Committee, Faculty of Medicine and Health Sciences, The Jan Kochanowski University, Kielce, Poland
Ethics committee address [1] 305398 0
Ethics committee country [1] 305398 0
Poland
Date submitted for ethics approval [1] 305398 0
Approval date [1] 305398 0
28/05/2019
Ethics approval number [1] 305398 0

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

Contacts
Principal investigator
Name 100242 0
A/Prof Marek Zak
Address 100242 0
The Jan Kochanowski University, ul. Zeromskiego 5, 25-369 Kielce, Poland,
Country 100242 0
Poland
Phone 100242 0
+48 41 3496909
Fax 100242 0
Email 100242 0
[email protected]
Contact person for public queries
Name 100243 0
Tomasz Sikorski
Address 100243 0
The Jan Kochanowski University, ul. Zeromskiego 5, 25-369 Kielce, Poland,
Country 100243 0
Poland
Phone 100243 0
+48 41 3496909
Fax 100243 0
Email 100243 0
[email protected]
Contact person for scientific queries
Name 100244 0
Marek Zak
Address 100244 0
The Jan Kochanowski University, ul. Zeromskiego 5, 25-369 Kielce, Poland,
Country 100244 0
Poland
Phone 100244 0
+48 41 3496909
Fax 100244 0
Email 100244 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
At this stage pertinent decisions have not yet been made.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7250Study protocol  [email protected]



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.