Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001000594
Ethics application status
Approved
Date submitted
22/05/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effectiveness of two rehabilitation programs using smovey® Vibroswing rings and dumbbells on balance, physical fitness, foot load, gait and risk of falls in older women.
Scientific title
Comparison of the effectiveness of two rehabilitation programs using smovey® Vibroswing rings and dumbbells on balance, functional ability, foot load, gait and risk of falls in older women.
Secondary ID [1] 309377 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
elder people 333872 0
physical fitness 333873 0
foot load 333874 0
balance impairment 333875 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330549 330549 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Original exercise program using smovey® Vibroswing rings and dumbbells
2 Currently, a progressive aging process of societies is observed. Old age is a period of life in which involutionary processes take place affecting all body systems, including anatomical and functional systems. Consequently, with age, the efficiency of the postural and motor systems responsible for postural stability gradually decreases, which translates into, among others, to an increased risk of falls.
Physiotherapists working with older people are constantly looking for new solutions thanks to which they could better and more effectively activate older people, improve their physical capacity, and thus prevent, among others: falls and their consequences. Opinions of practitioners show that seniors prefer to exercise with various types of equipment. They allow for diversification of repeated exercise regimens and may also have a positive impact on commitment and greater willingness to participate in rehabilitation. One of the newest offerings of exercise equipment dedicated to seniors are the smovey® Vibroswing rings. Smovey® Vibroswing is a vibrating ring system consisting of a spiral hose, 4 steel balls and a handle with a vibration damping element. By moving forward and then moving in the opposite direction, the 4 movable steel balls start to move freely. smovey® Vibroswing rings are recommended for patients with, among others: Parkinson's disease, diabetes, obesity, rheumatic disease, depression or children with ADHD. However, there are no publications in the available Polish and English literature confirming the above-described effectiveness of smovey® Vibroswing rings. There are no publications in the available literature comparing the effectiveness of training/rehabilitation using smovey® Vibroswing rings with other training equipment, including dumbbells.
The use of both smovey® Vibroswing rings and dumbbells is simple and intuitive. Thanks to their vibration properties, smovey® Vibroswing rings can be a promising type of therapy used in various ailments, diseases and dysfunctions, especially in the elderly, while dumbbells are one of the most commonly used training and rehabilitation tools, also used in work with the elderly. Therefore, due to the potential of the described accessories and the lack of scientific reports comparing their effectiveness, the aim of our research will be to compare the effectiveness of two rehabilitation programs using smovey® Vibroswing rings and dumbbells on balance, foot load and the risk of falls in older women.
3. Material – 60 women aged between 60 and 70 will take part in the research. The examined women will be divided into 3 groups:
ES group (20 women) – experimental – original exercise program using smovey® Vibroswing rings
ED group (20 women) – experimental – original exercise program using dumbbells
C group (20 women) – control – without therapeutic intervention.
The weight of the rings and dumbbells will be the same.
Inclusion criteria for studies: age between 60 and 70; no contraindications to undertake physical activity; no injuries within the musculoskeletal system up to 12 months before the start of the project; no cognitive impairment (MMSE score above 27 points).
Procedure - In both study groups, an identical rehabilitation program will be carried out, which will consist of 3 parts: a 5-10-minute warm-up (general development exercises), a 30-minute main part (aerobic, balance and strength exercises) and a 5-10-minute cool down ( breathing, relaxation and stretching exercises). Women from the first study group (ES group) will perform all exercises using smovey® Vibroswing rings, and women form the second study group (ED group) will perform all exercises using dumbbells. Both study groups will participate in physical activities three times a week for 6 weeks. Each session will last about 45 minutes, and the intensity of the effort will not exceed 40-60% of maximum heart rate. The heart rate of the study women will be monitored using a heart rate monitor (Polar Sport Tester, Polar Electro Oy, Finland). To monitor adherence to the intervention session attendance checklists will be used. Each session will be provided and supervised by a physiotherapist. Women will exercise in groups of 10 in a special room at the university.
Examples of the exercises:
Warm-up
Exercises in place while standing:
- circulation of the wrists, forearms and shoulders backwards
- active walking in place, with alternately working arms
- lifting arms sideways up, return
- moving the arms forward and backward (drawing a circle)
- side bends of the torso, arms along the torso
- arms crossed over the chest, torso twists
Walking exercises:
- march with alternating arm work
- skipping A marching (above the knee) with alternating shoulder work
- skipping C marching (heels towards the buttocks)
Main part
Exercise in place:
- learning and consolidating the correct grip of the equipment (equipment held in both hands) - learning the correct posture during exercise - parallel and alternating swings of varying intensity
- foot activation (transition from heels to toes) - balance
- activation of knee and hip joints during parallel and alternating swings
- raising the knees higher and higher (maximum to a right angle) during parallel and alternating swings
- cross swings in place
- parallel lateral swings in place
- parallel swings - switching from heels to toes – swings alternately - switching from heels to toes
- cross swings - switching from heels to toes
Movement exercises:
- parallel/alternating/crossing swings with lifting the leg, bent at the knee
- parallel/alternating/crossing swings with swinging legs forward and backward
- parallel/alternating/crossing swings and quarter squats
- parallel/alternating swings with a lunge/stride
- side swings parallel with leg abduction and adduction
- cross swings with abduction to change legs
- coordination exercises criss-cross in place / with footwork
Cool down part
- equipement on the shoulders
- activation of the lymphatic system in the sagittal, frontal and transverse planes
- massage of legs and arms with equipement while sitting or lying down
- breathing exercises
- lower rib breathing, in a standing, sitting or lying position.
Research tools
Senior Fitness Test – physical fitness
BioSway balance platform – balance and risk of falls
FreeMED platform – foot load
Biobit – gait
SF – 36 - quality of life
4. Provider of all intervention - physiotherapist (Master degree)
5. Model of delivery: face to face
6. Type of location where the intervention occurred - Central Research and Development Laboratory, University of Physical Education in Krakow, Poland
Intervention code [1] 328647 0
Prevention
Intervention code [2] 329003 0
Treatment: Devices
Comparator / control treatment
C group (20 women) – control – without therapeutic intervention (no exercise at all).
Control group
Active

Outcomes
Primary outcome [1] 338310 0
Senior Fitness Test – Muscle strength (lower and upper body)
Timepoint [1] 338310 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Primary outcome [2] 339125 0
Senior Fitmess Test - Aerobic endurance
Timepoint [2] 339125 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Primary outcome [3] 339126 0
Senior Fitness Test - Flexibility
Timepoint [3] 339126 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [1] 435388 0
BioSway balance platform – Postural Stability Test
Timepoint [1] 435388 0
First assessment of the parameter will take place at the beginning of the exercise program. The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [2] 435389 0
FreeMED platform – foot load
Timepoint [2] 435389 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [3] 435390 0
Biobit (wearable motion analysis system) - gait
Timepoint [3] 435390 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [4] 435391 0
SF – 36 short survey (questionnaire) - quality of life
Timepoint [4] 435391 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [5] 438641 0
Senior Fitness Test - Motor skills
Timepoint [5] 438641 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [6] 438642 0
Senior Fitness Test - Body composition
Timepoint [6] 438642 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [7] 438643 0
Biosway balance platform - Limits of Stability Test
Timepoint [7] 438643 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).
Secondary outcome [8] 438644 0
Biosway balance platform - Modified Clinical Test of Sensory Interaction and Balance (m-CTSIB)
Timepoint [8] 438644 0
First assessment of the parameter will take place at the beginning of the exercise program (week 0). The parameter will be assessed at the end of the exercise program (after 6 weeks).

Eligibility
Key inclusion criteria
Inclusion criteria for studies: age between 60 and 70; no contraindications to undertake physical activity; no injuries within the musculoskeletal system up to 12 months before the start of the project; no cognitive impairment (MMSE score above 27 points).
Minimum age
60 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

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)
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 (coss toin)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26331 0
Poland
State/province [1] 26331 0
Malopolska Voivodship

Funding & Sponsors
Funding source category [1] 313572 0
Government body
Name [1] 313572 0
Ministry of Science and Higher Education
Country [1] 313572 0
Poland
Funding source category [2] 316577 0
Government body
Name [2] 316577 0
Ministry of Science and Higher Education
Country [2] 316577 0
Poland
Primary sponsor type
Government body
Name
Ministry of Science and Higher Education
Address
Country
Poland
Secondary sponsor category [1] 315357 0
None
Name [1] 315357 0
Address [1] 315357 0
Country [1] 315357 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312753 0
Bioethics committee at the district medical chamber in Krakow
Ethics committee address [1] 312753 0
Ethics committee country [1] 312753 0
Poland
Date submitted for ethics approval [1] 312753 0
06/03/2024
Approval date [1] 312753 0
29/04/2024
Ethics approval number [1] 312753 0

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

Contacts
Principal investigator
Name 125782 0
Prof Katarzyna Filar-Mierzwa
Address 125782 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 125782 0
Poland
Phone 125782 0
+48 12 683 13 70
Fax 125782 0
Email 125782 0
[email protected]
Contact person for public queries
Name 125783 0
Aneta Bac
Address 125783 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 125783 0
Poland
Phone 125783 0
+48 12 683 13 70
Fax 125783 0
Email 125783 0
[email protected]
Contact person for scientific queries
Name 125784 0
Aneta Bac
Address 125784 0
University of Physical Education in Krakow Institute of Applied Science al. Jana Pawla II 7831-571 Krakow, Poland
Country 125784 0
Poland
Phone 125784 0
+48 12 683 13 70
Fax 125784 0
Email 125784 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.