Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000488000
Ethics application status
Approved
Date submitted
7/06/2010
Date registered
15/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of cycloid vibration therapy for promoting exercise recovery
Scientific title
Efficacy of cycloid vibration therapy for promoting exercise recovery in sedentary males
Secondary ID [1] 251697 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delayed onset muscle soreness 257172 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257321 257321 0 0
Physiotherapy
Musculoskeletal 257720 257720 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Muscle damage will be induced by performing 100 maximal voluntary eccentric isokinetic contractions of the knee extensors of the right leg at 45°/sec through an 80° range of motion. The cycloidal vibration therapy treatment will involve the participant placing a therapy cushion under their right thigh while in a seated position with their legs hanging at approximately 90° which will vibrate their upper leg. Participants will undergo 15 min of treatment immediately after the post-exercise assessments are completed, and then twice daily for 20 min for seven days.
Intervention code [1] 256319 0
Treatment: Devices
Comparator / control treatment
The stretching/self massage treatment will involve participants massaging their upper leg for 14 minutes [4 minutes of effleurage; 2 minutes of tapotement (clapping); and 8 minutes of petrissage (kneading)] and 6 minutes of stretching their quadriceps by bringing their heel up to their buttocks while standing and pulling the knee back to lengthen the quadriceps. Three lots of stretches will be performed, each time the stretch will be held for 30 seconds with 30 seconds between for 2 minutes. This treatment will be applied immediately after the post-exercise assessments are completed, and then twice daily for 20 min for seven days. Participants will be trained in the massage and stretching techniques.
Control group
Active

Outcomes
Primary outcome [1] 258225 0
Recovery of muscle force generating capacity. Maximal isometric knee extensor strength will then be assessed as the best of 3 maximal contractions with the knee flexed to an angle of 90 degrees on an isokinetic dynamometer (Biodex System 4, Chattanooga Group, USA).
Timepoint [1] 258225 0
There will be 6 timepoints. Baseline assessments will be conducted before muscle soreness induction and then further assessments will be conducted immediately after the muscle soreness induction, and again at 24 hours, 48 hours, 72 hours and 7 days post muscle soreness induction.
Secondary outcome [1] 263891 0
Alleviation of muscle pain. Muscle soreness will be evaluated using a visual analogue scale (VAS). The VAS will consist of a 100 mm horizontal line with anchor points consisting of 'no soreness' on the left to the 'worst soreness possible' on the right hand end. Participants will be seated and requested to extend the knee of the right leg (so the leg is horizontal) while a 5 kg mass is suspended from the ankle. The participants will place a mark at the point on the VAS corresponding to their perception of the soreness in the quadricep muscles of the leg. The extent of the muscle soreness will be quantified using the measured distance (in mm) from the left hand end of the continuum to the mark made by the participant.
Timepoint [1] 263891 0
There will be 6 timepoints. Baseline assessments will be conducted before muscle soreness induction and then further assessments will be conducted immediately after the muscle soreness induction, and again at 24 hours, 48 hours, 72 hours and 7 days post muscle soreness induction.
Secondary outcome [2] 263892 0
Change in muscle edema (measured by thigh circumference). Thigh circumference will be measured at the level of the mid-trochanterion-tibiale laterale site. The mean of three measures will be determined at each point.
Timepoint [2] 263892 0
There will be 6 timepoints. Baseline assessments will be conducted before muscle soreness induction and then further assessments will be conducted immediately after the muscle soreness induction, and again at 24 hours, 48 hours, 72 hours and 7 days post muscle soreness induction.
Secondary outcome [3] 263893 0
Change in markers of muscle damage and inflammation. Serum creatine kinase and myoglobin will be measured as markers of muscle damage using standard commercial assays. Serum C-reactive protein concentrations will be measured as a marker of inflammation using a commercial autoanalyser (Konelab 20 XTi, Thermo Electron Corporation).
Timepoint [3] 263893 0
Blood samples will be taken at 6 timepoints. Baseline sample will be taken before muscle soreness induction and then further samples will be taken immediately after the muscle soreness induction, and again at 24 hours, 48 hours, 72 hours and 7 days post muscle soreness induction.

Eligibility
Key inclusion criteria
sedentary (i.e. participate in regular physical activity no more than once per week for the purpose of improving or maintaining their physical fitness)
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have undertaken resistance training of the quadriceps muscles during the three months prior to their anticipated participation in this study, have knee, quadricep or other musculo-skeletal or medical problem which might interfere with their ability to perform the required exercise to induce muscle soreness or have experienced significant delayed onset muscle soreness (DOMS) in their quadriceps muscles during the three months prior to their anticipated participation in this study.

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)
Subjects will be recruited by newspaper advertisement and flyers. Volunteers will be screened via questionnaire to access their eligibility for the trial. Eligibility will be determined by the study coordinator. Treatment will be randomly allocated and will involve contacting the holder of the allocation schedule who is not directly involved in testing. The study will be single-blinded and treatment allocation will be concealed to research staff making the assements, but due to the nature of the treatments the participants will not be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256823 0
Commercial sector/Industry
Name [1] 256823 0
Advanced Lifestyle International
Country [1] 256823 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Jon Buckley
Address
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 256100 0
Individual
Name [1] 256100 0
Dr Rebecca Thomson
Address [1] 256100 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [1] 256100 0
Australia
Secondary sponsor category [2] 256101 0
Individual
Name [2] 256101 0
Professor Peter Howe
Address [2] 256101 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [2] 256101 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258842 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258842 0
Ethics committee country [1] 258842 0
Australia
Date submitted for ethics approval [1] 258842 0
Approval date [1] 258842 0
04/06/2010
Ethics approval number [1] 258842 0
P053/10

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

Contacts
Principal investigator
Name 31056 0
Address 31056 0
Country 31056 0
Phone 31056 0
Fax 31056 0
Email 31056 0
Contact person for public queries
Name 14303 0
Dr Rebecca Thomson
Address 14303 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 14303 0
Australia
Phone 14303 0
+61 8 8302 1822
Fax 14303 0
Email 14303 0
[email protected]
Contact person for scientific queries
Name 5231 0
Associate Professor Jon Buckley
Address 5231 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 5231 0
Australia
Phone 5231 0
+61 8 8302 1853
Fax 5231 0
Email 5231 0
[email protected]

No information has been provided regarding IPD availability


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.