Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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3 March 2020 |
Main ID: |
ACTRN12616001661460 |
Date of registration:
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01/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effects of vibroswing system exercises on physiological, functional and psychological changes in older adults with low back pain.
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Scientific title:
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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. |
Date of first enrolment:
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02/11/2016 |
Target sample size:
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100 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616001661460.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);
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Phase:
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Countries of recruitment
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Poland
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Contacts
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Name:
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Miss Martyna Kasper
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Address:
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Opole Medical School
Katowicka 68 street
45-060 Opole
Poland |
Telephone:
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+48512471544 |
Email:
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kasperm@wsm.opole.pl |
Affiliation:
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Name:
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Prof Grzegorz Zurek
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Address:
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Opole Medical School
Katowicka 68 street
45-060 Opole
Poland |
Telephone:
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+48 77 44 10 882 |
Email:
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zurekg@wsm.opole.pl |
Affiliation:
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Key inclusion & exclusion criteria
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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
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.
Age minimum:
60 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Musculoskeletal - Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation
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Chronic low back pain; Chronic low back pain
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Intervention(s)
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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.
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Primary Outcome(s)
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Static balance will be assessed by stabilometric platform: measurement of centre of gravity excursions in the anteroposterior (AP) and mediolateral (ML) directions.[Baseline and after the 10-week intervention]
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Body composition assessed by means of Bio-electrical impedance using InBody120[Baseline and after the 10-week intervention.]
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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). [Baseline and after the 10-week intervention]
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Secondary Outcome(s)
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Visual Analog Scale for back pain (VAS Pain).[Baseline, after 10 and 20-week intervention.]
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Source(s) of Monetary Support
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Opole Medical School
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Ethics review
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Status: Approved
Approval date: 24/10/2016
Contact:
Opole Medical School Ethics Committee
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Results
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Results available:
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Yes |
Date Posted:
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27/02/2020 |
Date Completed:
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10/02/2017 |
URL:
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