Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000384459
Ethics application status
Approved
Date submitted
5/02/2016
Date registered
23/03/2016
Date last updated
15/06/2021
Date data sharing statement initially provided
15/06/2021
Date results provided
15/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The assessment of the efficacy of different recovery strategies after fatiguing exercise.
Scientific title
The assessment of the efficacy of different recovery strategies after fatiguing exercise.
Secondary ID [1] 288483 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tissue overload 297518 0
muscle recovery after fatigue 297519 0
Condition category
Condition code
Musculoskeletal 297718 297718 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 297719 297719 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will be invited to laboratory for 3 visits with one week intervals and for 1 pre-test visit for familiarisation. Each visit will begin with a warm-up, which consists of cycling for 5 minutes at a comfortable, self-selected speed. Measurements of the bioelectrical activity (EMG) of the vastus lateralis oblique (VLO), the vastus medialis oblique (VMO), and the rectus femoris (RF) muscles and the torque, work and power of the knee flexor and extensor muscles will be performed during isokinetic testing at a velocity 90 degrees/s. The measurements will be perform before fatiguing exercise, after exercising and after one of the recovery modes. During pre-test visit the maximum velocity of each subject’s treadmill running will be determined. The initial speed of the treadmill is 5 km/h and will be increased 1 km/h every 2 minutes, and physical effort will be performed to exhaustion, or to refusal to continue by the subject. From the maximal treadmill speed determined during pre-test visit the 120% will be calculated. The 100% it is the speed at the end of the effort when the subject is exhausted, but the 120% of this speed will be applicated during the effort when the subject will not be fatigued. The fatiguing exerccise will involve ten treadmill runs, each one-minute long (performed at the intensity of 120% of maximal treadmiil speed determined during pre-test visit) interspaced with two-minute breaks. During each two-minute break, the treadmill will be stopped and the subject will rest by standing on the treadmill. Then the treadmill will be started and accelerated to the 120% of maximal treadmill speed. The test physical effort will last 30 minutes (10 one-minute runs and 10 two-minute breaks). If the subject will not be able to complete the test at the required intensity, the velocity will be reduced by 0.5 km/h. Each of the recovery mode applied for 20 minutes immediately following completion of the fatiguing exercise. It will involve pedaling on the cycle ergometer (at a velocity of 60 rpm with a 10W load) pedaling on the arm ergometer (at a velocity of 60 rpm with a 10W load), or passive rest in a sitting position. Each measurements will be performed by one physiotherapists during one-on-one consultation.
Intervention code [1] 293819 0
Prevention
Comparator / control treatment
The 20 min of passive rest in sitting position administrated after fatiguing exercise will be the control intervention
Control group
Active

Outcomes
Primary outcome [1] 297263 0
The efficacy of two modes of post-exercise active recovery and passive recovery in removing of fatigue assessed by changes in lower limbs muscles strength (isokinetic dynamometer) and bioelectrical activity (EMG)
Timepoint [1] 297263 0
The measurements are performed at 3 visits with one week intervals, and at each visit directly before fatiguing exercise, immediately after exercising and after 20 minutes in one of the recovery modes
Secondary outcome [1] 320516 0
The influence of 3 recovery methods on muscle recovery after fatigue assessed by lower limb muscles strength analysis - evaluated by isokinetic dynamometer
Timepoint [1] 320516 0
The measurements are performed at 3 visits with one week intervals, and at each visit directly before fatiguing exercise, immediately after exercising and after 20 minutes in one of the recovery modes
Secondary outcome [2] 320518 0
The influence of 3 recovery methods on muscle recovery after fatigue assessed by bioelectrical activity of the lower limb muscles.
Timepoint [2] 320518 0
The measurements are performed at 3 visits with one week intervals, and at each visit directly before fatiguing exercise, immediately after exercising and after 20 minutes in one of the recovery modes

Eligibility
Key inclusion criteria
Mountain canoeists and football players belonged to a regional team
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous history of acute injury in the one year prior to the enrollment on the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/09/2010
Date of last participant enrolment
Anticipated
Actual
8/12/2017
Date of last data collection
Anticipated
Actual
15/01/2018
Sample size
Target
60
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 7572 0
Poland
State/province [1] 7572 0

Funding & Sponsors
Funding source category [1] 292820 0
Self funded/Unfunded
Name [1] 292820 0
Country [1] 292820 0
Primary sponsor type
Individual
Name
prof. Anna Mika
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 291563 0
None
Name [1] 291563 0
Address [1] 291563 0
Country [1] 291563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294337 0
The Ethical Committee of Regional Medical Chamber in Krakow
Ethics committee address [1] 294337 0
Ethics committee country [1] 294337 0
Poland
Date submitted for ethics approval [1] 294337 0
Approval date [1] 294337 0
23/04/2008
Ethics approval number [1] 294337 0
31/KBL/OIL/2008

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

Contacts
Principal investigator
Name 63310 0
Prof Anna Mika
Address 63310 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63310 0
Poland
Phone 63310 0
+48 12 6831134
Fax 63310 0
+48 12 6831300
Email 63310 0
[email protected]
Contact person for public queries
Name 63311 0
Anna Mika
Address 63311 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63311 0
Poland
Phone 63311 0
+48 12 6831134
Fax 63311 0
+48 12 6831300
Email 63311 0
[email protected]
Contact person for scientific queries
Name 63312 0
Anna Mika
Address 63312 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 63312 0
Poland
Phone 63312 0
+48 12 6831134
Fax 63312 0
+48 12 6831300
Email 63312 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
SourceTitleYear of PublicationDOI
EmbaseComparison of two different modes of active recovery on muscles performance after fatiguing exercise in mountain canoeist and football players.2016https://dx.doi.org/10.1371/journal.pone.0164216
N.B. These documents automatically identified may not have been verified by the study sponsor.