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Trial registered on ANZCTR


Registration number
ACTRN12616001661460
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
1/12/2016
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of vibroswing system exercises on physiological, functional and psychological changes in older adults with low back pain.
Scientific title
The effects of vibroswing system exercises on balance, body composition, bioelectrical activity of muscles and quality of life in older adults with low back pain.
Secondary ID [1] 290460 0
None
Universal Trial Number (UTN)
U1111-1186-6363
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 300823 0
Condition category
Condition code
Musculoskeletal 300648 300648 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300815 300815 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of study is to assess physiological, functional and psyhological changes after 10 weeks vibroswing system exercises in older adults.

Intervention:
All participants (n=100) will be randomized and randomly assigned into two comparative groups (A, B). Group A will be the study group, where vibroswing exercises equipment will be used. Group B will be a control group where the participants will exercise with the same equipment but without vibration effect.
All participants will be instructed how to use the smovey vibroswing system (is a swinging-ring system and consists of a spiraled tube, four steels balls, and a grip with cushioning elements ) and will complete 30-minute group sessions of exercise twice a week for 10 weeks with attendance at all sessions. Participants will be assessed at pre and post intervention by the instruments: electromyograph, balance platform, body analyzer and Quality of life SF-36 questionnaire (the Polish version). All sessions for groups A & B (study & control) will be supervised by University staff or trained students (all with 1st aid certification).

The nature of the program for both groups will be the same:

Vibroswing system exercises (participants always hold in each hand the vibroswing equipment while performing the exercises) with 15 repetitions (the number of repetitions is decrease to 10 when Borg rating reaches 6 out of 10) :
1. 5 min Warm Up
2. 15 min Aerobic Exercise with equipment in upright body position with knees slightly bent:
(e.g. coordination and balance exercises):
- Swing forward and backward alternatively with the right and left arms. Slightly lift right or left leg off the ground for a few swings.
- Swing parallel and evenly forward and backwards from the shoulders.
- Swing the arms horizontally back as far as possible at shoulder height & bring the arms together in front of the body. The more the arms are extended the more intensity.
- Crossover start position. Swing the arms so that they cross alternately in front of the body (without touching).
- Swing the arms alternately to the right or left side at the same time. Swing both arms to the left side as you step with the right leg at the same time – and reversed.
- Step one leg back and lower the buttocks so the rear knee is slightly off the ground and the front knee does not move forward past the tip of the toes – perform even parallel swings – and change legs. From the same leg stance swing with alternating arms.

3. 10 min Stretching: major muscle groups
4. 5 min Cool-down: relaxation and breathing

There will be breaks between exercises and the exercise program is progressive and tailored towards individual capabilities and preferences (Borg rating of perceived exertion scale measured during exercise 0-10).
Intervention code [1] 296309 0
Treatment: Devices
Comparator / control treatment
Participants in the B group (control) will exercise with the same equipment than A group (study) but with no vibration effects.
Control group
Placebo

Outcomes
Primary outcome [1] 300066 0
Surface electromyography: Noraxon MyoSystem 1400A (Noraxon, USA) will be used to assess the resting muscle bioelectrical activity of the erector spinae muscles (microV) in prone position with the lumbar vertebral columns slightly flexed (SENIAM Recommenadtions).
Timepoint [1] 300066 0
Baseline and after the 10-week intervention
Primary outcome [2] 300067 0
Static balance will be assessed by stabilometric platform: measurement of centre of gravity excursions in the anteroposterior (AP) and mediolateral (ML) directions.
Timepoint [2] 300067 0
Baseline and after the 10-week intervention
Primary outcome [3] 300239 0
Body composition assessed by means of Bio-electrical impedance using InBody120
Timepoint [3] 300239 0
Baseline and after the 10-week intervention.
Secondary outcome [1] 329462 0
Visual Analog Scale for back pain (VAS Pain).
Timepoint [1] 329462 0
Baseline, after 10 and 20-week intervention.

Eligibility
Key inclusion criteria
Individuals are potentially eligible if they meet all of the following criteria: reported chronic low back pain that has lasted for a minimum of 6 months, aged 60 + , can provide written informed consent to participate in the study, can perform all the physical fitness tests, have capacity to understand instructions
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physicians may consider a patient unsuitable to enroll if they have any of the following: Participation in regular physical exercise programs more than once a week for 30 minutes or more, during two weeks, in the last five years.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2016
Date of last participant enrolment
Anticipated
25/11/2016
Actual
25/11/2016
Date of last data collection
Anticipated
3/02/2017
Actual
10/02/2017
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8367 0
Poland
State/province [1] 8367 0

Funding & Sponsors
Funding source category [1] 294870 0
University
Name [1] 294870 0
Opole Medical School
Country [1] 294870 0
Poland
Primary sponsor type
University
Name
Opole Medical School
Address
Katowicka 68 street, 45-060 Opole,
Country
Poland
Secondary sponsor category [1] 293709 0
None
Name [1] 293709 0
Address [1] 293709 0
Country [1] 293709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296250 0
Opole Medical School Ethics Committee
Ethics committee address [1] 296250 0
Katowicka 68 street, 45-060 Opole,
Ethics committee country [1] 296250 0
Poland
Date submitted for ethics approval [1] 296250 0
10/10/2016
Approval date [1] 296250 0
24/10/2016
Ethics approval number [1] 296250 0
44/2016

Summary
Brief summary
The research hypothesis is that the vibroswing system exercise will show short term and/or long term effects in decreasing pain and disability in older adults with non specific low back pain. Low back pain is still a significant medical problem and challenge for the medicine specialist as well as physiotherapist. Recent interest has emerged on the use of Whole Body Vibration (WBV) and specially designed exercise equpiment as a potential therapy that may produce improvements in muscle strength, balance and decrease pain. There is a lot of exercise programs are used to treat low back pain with tool (pilates, yoga, manual therapy).
The Smovey is a new exercise tool, which can be used for regular activity and exercise. It is a spiraled tube, four steels balls inside and a grip. When the patient is performing a forward motion the four steel balls roll inside the tube and create a pulsating vibration. The weight of one ring (at rest) is approximately 500 grams, and through the centrifugal forces, created by the swinging motion, the perceivable weight can increase to almost 5 kilos with a frequency of 60 hertz.
The main scientific aim of the project is an objective evaluation of the influence of vibroswing system exercise on older adults with chronic low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70150 0
Prof Grzegorz Zurek
Address 70150 0
Opole Medical School
Katowicka 68 street
45-060 Opole
Country 70150 0
Poland
Phone 70150 0
+48 77 44 10 882
Fax 70150 0
Email 70150 0
[email protected]
Contact person for public queries
Name 70151 0
Martyna Kasper
Address 70151 0
Opole Medical School
Katowicka 68 street
45-060 Opole
Country 70151 0
Poland
Phone 70151 0
+48512471544
Fax 70151 0
Email 70151 0
[email protected]
Contact person for scientific queries
Name 70152 0
Grzegorz Zurek
Address 70152 0
Opole Medical School
Katowicka 68 street
45-060 Opole
Country 70152 0
Poland
Phone 70152 0
+48 77 44 10 882
Fax 70152 0
Email 70152 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
The authors tend to publish patients, but the decision has not yet been made. This is due to the lack of experience in publishing this type of data and the fear of improper use of this data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4634Study results articleYes Zurek, G.; Kasper-Jedrzejewska, M.; Dobrowolska, I... [More Details]

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