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Trial registered on ANZCTR


Registration number
ACTRN12621001294842
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
24/09/2021
Date last updated
24/09/2021
Date data sharing statement initially provided
24/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative efficacy of intermittent pneumatic compression and negative pressure therapy on muscle function and soreness. A randomized controlled trial
Scientific title
Comparative efficacy of intermittent pneumatic compression and negative pressure therapy on delayed-onset muscle soreness in young, healthy, physically active men. A randomized controlled trial
Secondary ID [1] 302690 0
None
Universal Trial Number (UTN)
U1111-1260-7055
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
delayed onset muscle soreness (DOMS)
 319681 0
exercise induced muscle damage (EIMD) 323726 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317610 317610 0 0
Physiotherapy
Musculoskeletal 319744 319744 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All procedures and therapies were conducted in a laboratory setting in the university research centre. Immediately after DOMS induction (5x20 jumps from a box of 60 cm high) participant performed a session of intermittent compression therapy (ICT) or intermittent negative pressure therapy (INPT) or sham microcurrent therapy (Control) for the lower body (legs and pelvis). A duration of 30 minutes was set for all groups. In all groups, therapy was repeated 24 and 48 hours after DOMS induction. All therapies sessions were provided by an experienced physiotherapist. INPT was performed by Vacusport Regeneration System (Weyergans LTD, Germany) and ICT was performed by BOA - Max 2 (Metrum CryoFlex, Poland). For INPT, program # 2 was used. The program consisted of five six-minute stages. In the first stage, the ratio of the duration of the vacuum and pause, measured in seconds, was 7: 7 at the turbine power level 8, which corresponded to a vacuum of -33 mbar; in the second, respectively 8: 6 and power 10 (- 37mbar); services 8: 8 and 13 (-43mbar); on the fourth 9: 9 and 15 (- 49mbar); on the fifth 10:10 and power 15 (- 49mbar). For ICT sport massage program was set. The pressure in the ventricles corresponded to the diastolic pressure of the examined patients and was in all cases 70-80 mmHg. The "sports massage" program was selected, consisting in pumping three chambers in each leg simultaneously, starting from the distal parts of the lower limbs. 10 treatment cycles were set, with each cycle time being 3 minutes, a typical gradient and a pace of 15. For the potential increase of the massage effect, the option of a pulsating massage was set, which was activated after the chambers were completely filled. After all 24 chambers were inflated, the machine aspirated these chambers simultaneously and the next cycle began.
Intervention code [1] 319026 0
Rehabilitation
Intervention code [2] 319027 0
Treatment: Devices
Comparator / control treatment
Sham therapy (simulated microcurrent therapy) was performed using the Sonicator Plus 940 (Mettler Electronics Corporation. Anaheim, USA). Two current circuits were used (both lower limbs). Self-adhesive electrodes were placed on the quadriceps muscle. The procedure lasted 30 minutes without turning on the device. The respondents had no insight into the control panel, and the device did not inform about the elapsed time with sound signals. In all groups, therapy was repeated immediately, 24 and 48 hours after DOMS induction.
All procedures and therapies were conducted by experienced physiotherapists in a laboratory setting in the university research centre.
Control group
Active

Outcomes
Primary outcome [1] 325655 0
Muscle soreness assessed using a 100mm Visual Analogue Scale (VAS), following pressing a participant’s leg for 3 seconds (central area between the base of the patella and anterior superior iliac spine).
Timepoint [1] 325655 0
Assessments conducted: prior to and following DOMS induction and in 1h, 24h, and 48h after exercise.
The primary timepoint is 48 hours post eccentric exercise (DOMS induction).
Primary outcome [2] 325656 0
Maximal isokinetic strength of knee extensors muscles, measured with the use of the Biodex System 4 Pro measuring device (Biodex Medical System, USA). Participants were in a sitting position, pelvis, thighs and trunk stabilised with straps. both legs examined. 5 repetitions in a 60 deg/sec mode.
Timepoint [2] 325656 0
Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary time point is 48 hours post-DOMS induction.
Primary outcome [3] 325657 0
Maximal active range of motion-ROM of knee measured with the use of the goniometer. Participants were in a lying position, pelvis and trunk stabilised with straps. both legs examined by physiotherapist
Timepoint [3] 325657 0
Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary timepoint is 48 hours post DOMS induction
Secondary outcome [1] 388701 0
Creatine kinase (CK) activity in plasma, Determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland
Timepoint [1] 388701 0
Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction.
Secondary outcome [2] 401238 0
Lactic dehydrogenase (LDH) activity in plasma, Determined with the use of a diagnostic kit Cat. No. C6428-075, Alpha Diagnostics, Poland
Timepoint [2] 401238 0
Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction.
Secondary outcome [3] 401239 0
Additional primary outcome
Maximal isokinetic strength of knee flexor muscles, measured with the use of the Biodex System 4 Pro measuring device (Biodex Medical System, USA). Participants were in a sitting position, pelvis, thighs and trunk stabilised with straps. both legs examined. 5 repetitions in a 60 deg/sec mode.
Timepoint [3] 401239 0
Assessed at timepoints: before DOMS exercise, 1, 24, 48 hours after DOMS induction. The primary timepoint is 48 hours post DOMS induction.

Eligibility
Key inclusion criteria
Healthy, moderatey physically active participants. No smoking , no drug taking.
Minimum age
18 Years
Maximum age
28 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
competitive physical activity;
sedentary lifestyle;
lower limb or spine injuries within a year prior to the study;
current inflammations;
contraindications to INPT or ICT

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)
The randomisationwas conducted using sealed and opaque envelopes to conceal each upcoming allocation during experiment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants assigned to the groups through randomisation done online on https://www.randomizer.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results are expressed at mean (+/-SD) and were analysed using a repeated measures analysis of variance (ANOVA) to determine time, therapy and interaction effects. A Greenhouse–Geisser correction was done to produce the F ratio adjusting for lack of sphericity in a repeated measures ANOVA. Tukey's post-hoc paired samples t-test was used to determine any differences between trials. The alpha level was accepted at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
7/10/2019
Date of last data collection
Anticipated
Actual
11/10/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 23096 0
Poland
State/province [1] 23096 0
Biala Podlaska

Funding & Sponsors
Funding source category [1] 307126 0
University
Name [1] 307126 0
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Country [1] 307126 0
Poland
Primary sponsor type
University
Name
Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Address
Akademicka 2, 21-500 Biala Podlaska, Poland
Country
Poland
Secondary sponsor category [1] 307702 0
None
Name [1] 307702 0
Address [1] 307702 0
Country [1] 307702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307238 0
The Research Ethics Committee, University of Physical Education, Warsaw, Poland
Ethics committee address [1] 307238 0
Ethics committee country [1] 307238 0
Poland
Date submitted for ethics approval [1] 307238 0
01/02/2018
Approval date [1] 307238 0
13/03/2018
Ethics approval number [1] 307238 0
SKE 01-02/2018

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

Contacts
Principal investigator
Name 106518 0
Dr Szczepan Wiecha
Address 106518 0
Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska
Country 106518 0
Poland
Phone 106518 0
+48 602349181
Fax 106518 0
Email 106518 0
szczepan.wiecha@awf-bp.edu.pl
Contact person for public queries
Name 106519 0
Szczepan Wiecha
Address 106519 0
Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska
Country 106519 0
Poland
Phone 106519 0
+48 602349181
Fax 106519 0
Email 106519 0
szczepan.wiecha@awf-bp.edu.pl
Contact person for scientific queries
Name 106520 0
Szczepan Wiecha
Address 106520 0
Jozef Pilsudski University of Physical Education in Warsaw. Akademicka 2, 21-500 Biala Podlaska
Country 106520 0
Poland
Phone 106520 0
+48 602349181
Fax 106520 0
Email 106520 0
szczepan.wiecha@awf-bp.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers
Available for what types of analyses?
Available for statistical analyses with lack of sufficient data in manuscript
How or where can data be obtained?
Principal Investigator, with requirement to sign data access agreement.
Contact by email: szczepan.wiecha@awf-bp.edu.pl


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9674Ethical approval    380865-(Uploaded-10-11-2020-01-30-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe efficacy of intermittent pneumatic compression and negative pressure therapy on muscle function, soreness and serum indices of muscle damage: a randomized controlled trial.2021https://dx.doi.org/10.1186/s13102-021-00373-2
N.B. These documents automatically identified may not have been verified by the study sponsor.