Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12623001240639
Ethics application status
Approved
Date submitted
17/03/2023
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the impact of an original exercise program using smovey® Vibroswing rings on physical fitness, balance, foot load, risk of falls and upper limb muscle strength, hand-eye coordination and quality of life in older women.
Scientific title
Evaluation of the impact of an original exercise program using smovey® Vibroswing rings on balance, feet load, risk of falls, physical fitness, upper limb muscle strength and quality of life in older women.
Secondary ID [1] 309226 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
older people 329383 0
elderly 330671 0
risk of falls 330672 0
physical fitness 330673 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326325 326325 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Original exercise program using smovey® Vibroswing rings
2. Currently, a progressive aging of societies is observed. Senility is a period of life in which involutionary processes take place concerning all body systems, including anatomical and functional systems. Therefore, the key task is to undertake such actions, the implementation of which will be conducive to the so-called successful model of senility. Physiotherapists working with the elderly are constantly looking for new solutions thanks to which they could better and more effectively activate the elderly, improve their physical capacity, and thus prevent e.g. failures and their consequences. The opinions of practitioners show that seniors prefer to exercise with various types of equipment. One of the latest offers of exercise equipment dedicated to seniors are smovey® Vibroswing rings. According to the manufacturers of this equipment, exercises with the use of smovey® Vibroswing rings, e.g. they activate 97% of muscles, affect the balance of the body, prevent falls, make the connective tissue more flexible, strengthen the cardiovascular system and stimulate metabolism. However, in the available literature, there are very few publications confirming the above-described effectiveness of smovey® Vibroswing rings.
Smovey® Vibroswing System is an exercise set, a system of two swinging rings, consisting of a spiral hose inside, with 4 steel balls and a handle. The movement of the balls creates vibrations, from 0-460 Hz, which are transmitted through the handle and provide local vibrations transmitted through the hands to the rest of the body. The average amplitude measured by the manufacturer on the handle using a special sensor is about 60 Hz. The weight of the equipment is 0.5 kg. During movement, it can reach up to 5 kg due to the centrifugal force. Smovey® is an exercise device that generates vibrations stochastically, i.e. with a constantly and rapidly changing frequency. During the exercises, two rings held in the hands are used.
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
E group (20 women) – experimental – original exercise program
C group (20 women) – control – without therapeutic intervention.
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 second study group (ES group) will perform all exercises using smovey® Vibroswing rings. 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.
Examples od 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
- rings on the shoulders
- activation of the lymphatic system in the sagittal, frontal and transverse planes
- massage of legs and arms with smovey 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
Pablo system - upper limb muscle strength and hand-eye coordination
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] 325669 0
Prevention
Comparator / control treatment
C group (20 women) – control – without therapeutic intervention (no exercise at all).
Control group
Active

Outcomes
Primary outcome [1] 334186 0
Senior Fitness Test – physical fitness
Timepoint [1] 334186 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).
Primary outcome [2] 336172 0
BioSway balance platform – balance and risk of falls
Timepoint [2] 336172 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).
Primary outcome [3] 336173 0
FreeMED platform – foot load
Timepoint [3] 336173 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 [1] 419773 0
Pablo system - upper limb muscle strength and hand-eye coordination
Timepoint [1] 419773 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] 427209 0
SF – 36 - quality of life
Timepoint [2] 427209 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).

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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25329 0
Poland
State/province [1] 25329 0
Malopolska Voivodship

Funding & Sponsors
Funding source category [1] 313414 0
Government body
Name [1] 313414 0
Ministry of Science and Higher Education
Country [1] 313414 0
Poland
Primary sponsor type
Government body
Name
Ministry of Science and Higher Education
Address
ul. Hoza 20 00-528 Warsaw, Poland
Country
Poland
Secondary sponsor category [1] 315186 0
None
Name [1] 315186 0
Address [1] 315186 0
Country [1] 315186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312630 0
Thematic team for ethics in scientific research of physiotherapists at the National Chamber of Physiotherapists
Ethics committee address [1] 312630 0
al. Jerozolimskie 9302-001 Warsaw, Poland
Ethics committee country [1] 312630 0
Poland
Date submitted for ethics approval [1] 312630 0
03/04/2023
Approval date [1] 312630 0
05/06/2023
Ethics approval number [1] 312630 0
KIF/33/5.06.2023

Summary
Brief summary
Introduction: Currently, a progressive aging of societies is observed. Senility is a period of life in which involutionary processes take place concerning all body systems. Physiotherapists working with the elderly are constantly looking for new solutions thanks to which they could better and more effectively activate the elderly. The opinions of practitioners show that seniors prefer to exercise with various types of equipment. One of the latest offers of exercise equipment dedicated to seniors are smovey® Vibroswing rings. However, in the available literature, there are very few publications confirming the above-described effectiveness of smovey® Vibroswing rings. Aim: Evaluation of the impact of an original exercise program using smovey® Vibroswing rings on selected parameters in older women. The hypothesis: The original rehabilitation program using smovey® Vibroswing rings will have a significantly greater impact on the physical fitness, balance, foot load, risk of falls and upper limb muscle strength, hand-eye coordination and quality of life of the examined women compared to the rehabilitation program itself and the control group. Material: 60 women aged between 60 and 70 divided into 3 groups: ES group (20 women) – experimental – original exercise program using smovey® Vibroswing rings, E group (20 women) – experimental – original exercise program, C group (20 women) – control – without therapeutic intervention. Procedure: In both study groups, an identical rehabilitation program will be carried out. Women from the second study group (ES group) will perform all exercises using smovey® Vibroswing rings. Both study groups will participate in physical activities three times a week for 6 weeks, each session will last about 45 minutes. Research tools: Senior Fitness Test, BioSway balance platform, FreeMED platform, Pablo system, SF – 36 questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125346 0
Prof Aneta Bac
Address 125346 0
University of Physical Education in KrakowInstitute of Applied Scienceal. Jana Pawla II 7831-571 Krakow, Poland
Country 125346 0
Poland
Phone 125346 0
+48 12 683 13 70
Fax 125346 0
+48 12 683 14 62
Email 125346 0
aneta.bac@awf.krakow.pl
Contact person for public queries
Name 125347 0
Prof Aneta Bac
Address 125347 0
University of Physical Education in KrakowInstitute of Applied Scienceal. Jana Pawla II 7831-571 Krakow, Poland
Country 125347 0
Poland
Phone 125347 0
+48 12 683 13 70
Fax 125347 0
+48 12 683 14 62
Email 125347 0
aneta.bac@awf.krakow.pl
Contact person for scientific queries
Name 125348 0
Prof Aneta Bac
Address 125348 0
University of Physical Education in KrakowInstitute of Applied Scienceal. Jana Pawla II 7831-571 Krakow, Poland
Country 125348 0
Poland
Phone 125348 0
+48 12 683 13 70
Fax 125348 0
+48 12 683 14 62
Email 125348 0
aneta.bac@awf.krakow.pl

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.